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Social Security Administration Warns About Online Look-Alikes
08/01/2014 14:17:51
Social Security Administration Warns About Online Look-Alikes

Looking for information about Social Security? Make sure you’re going to the right place.

The Social Security Administration (SSA) is warning that it’s found Twitter handles, Facebook pages, websites and apps that look official but aren’t connected to the agency. Sometimes they’re outright scams to steal your personal information.

For official information from the Social Security Administration, go to SocialSecurity.gov or ssa.gov, or follow the Twitter handles @SocialSecurity and @TheSSAOIG. Read SSA’s Office of the Inspector General blog post for more.

Rapid Price Increases for Some Generic Drugs Catch Users by Surprise
07/18/2014 15:31:32
Rapid Price Increases for Some Generic Drugs Catch Users by Surprise

The first sign of trouble came when Dr. Barry Lindenberg, a cardiologist, received a three-page insurance form in January, demanding he get preapproval to prescribe one of the oldest known heart medicines.

His patient had been on the drug, digoxin, for many years. A mainstay of treating older patients with rapid rhythm disturbances, it was first described in the medical literature in 1785. Millions of Americans still use it every day, and many had long paid just pennies a pill.

“I wrote on the form: ‘ARE YOU KIDDING ME?’ ” said Dr. Lindenberg, who practices in Schenectady, N.Y.

What the cardiologist did not know then was that the price of generic digoxin was rapidly rising. The three companies selling the drug in the United States had increased the price they charge pharmacies, at least nearly doubling it since late last year, according to EvaluatePharma, a London-based consulting firm.

For patients, that meant the prices at pharmacies often tripled from last October to this June, according to Doug Hirsch, chief executive of GoodRx.com, a website that tracks drug pricing to help consumers find good deals. And while the average price tag at the pharmacy for a month of digoxin this year is still relatively cheap, about $50, he said, some patients are now encountering costs of more than $1,000. That can translate into co-pays of hundreds of dollars.

No wonder, Dr. Lindenberg said, that he began hearing from patients requesting a drug change because they could not afford digoxin. He noted that one patient did not fill her prescription because it would have cost her $1.60 per pill, and that she ended up in intensive care.

Large price increases in the United States for vital medicines for the young, such as vaccines, have been mirrored by similar rises in some of the most basic treatments for older patients, like digoxin. Though there are many newer types of drugs to treat heart disease, for some patients there are no effective substitutes; digoxin is on the World Health Organization’s list of essential medicines.

In recent years, generics have curbed the rise of drug prices, saving the American health care system billions of dollars. After the patents for Lipitor, the cholesterol drug, and Ambien, the sleeping pill, expired in the last few years, for example, generics entered the market and prices plummeted.

But increasingly, experts say, the costs of some generic drugs are going the other way. The prices paid by pharmacies for some generic versions of Fiorinal with codeine (for migraines) and Synthroid (a thyroid medicine) as well as the generic steroid prednisolone have all more than doubled since last year, EvaluatePharma found. In January, the National Community Pharmacists Association called for a congressional hearing on generic drug prices, complaining that those for many essential medicines grew as much as “600, 1,000 percent or more” in recent years. The price jumps especially affected smaller pharmacies, which do not have the clout of big chains to bargain for discounts.

Digoxin provides a telling case study. There was no drug shortage, according to the Food and Drug Administration, that might explain the increase. There was no new patent or new formulation. Digoxin is not hard to make. What had changed most were the financial rewards of selling an ancient, lifesaving drug and company strategies intended to reap the benefits.

Though generic medicines are far cheaper to bring to market than brand-name drugs because they involve little research and development, they also are priced lower because generics typically face intense competition. But Dr. Aaron Kesselheim, a professor of health economics at the Harvard School of Public Health, noted, “Studies show it is not until you have four or five generics in the market that the prices really are down.”

By late 2013, a number of generic manufacturers had largely stopped producing and distributing digoxin, then a cheap medicine whose use had declined, leaving only two companies dominant in the market. Both businesses — the Lannett Company and Global Pharmaceuticals, a division of Impax Laboratories — are small companies whose bottom line can rise and fall on the sales of a single drug.

Then this January, the Swiss manufacturer Covis began selling an “authorized generic.” Such medicines are made according to the specific formula of the company that makes the branded drug and holds the original patent (GlaxoSmithKline in the case of digoxin), and tend to be more expensive than a typical generic.

In late 2013, one of the companies began a price increase, and the others soon followed, records show. “It’s quite difficult to pinpoint who was the catalyst, but we are seeing a big step up,” said Anthony Raeside, an analyst at EvaluatePharma.

In January, the price pharmacies paid for the dose of digoxin Dr. Lindenberg had prescribed his patient was about $1.10 per pill for the authorized generic and about 40 cents a pill for the two other products, about double that just six months before.

Only one of the companies, Lannett, responded to calls and emails for comment and would not discuss the specific case of digoxin, saying only in an emailed statement, “On occasion and for a variety of reasons generic drug makers can and do raise prices.” Those factors, it said, included problems acquiring raw material, increased costs of complying with Food and Drug Administration requirements and manufacturers exiting the market.

Lannett, the major supplier in the United States, has benefited. The company’s reported sales for cardiovascular products — its major drug in that category is digoxin — rose to $16.9 million from $4.5 million in just a few months, according to company conference calls with investors. In a February call, Arthur Bedrosian, the chief executive, said Lannett’s net sales had increased 84 percent year on year, and were the best in the company’s history.

The Federal Trade Commission has been examining anticompetitive practices in the generic drug industry, but there is often little the agency can do if businesses take advantage of a monopoly or near monopoly, “if it happens naturally” through companies leaving the market, said Jaime King, a professor at the University of California Hastings College of the Law. Mitch Katz, a spokesman for the agency, would not say if it was looking into digoxin.

Insurers can sometimes react to high drug prices by bargaining with manufacturers for better rates. But, Dr. Kesselheim said, those negotiations tend to focus on very expensive new products, like infused drugs to treat arthritis and some cancer treatments, where a good discount could save tens of millions a year.

With cheaper drugs, insurers use simpler tools to discourage use and prod doctors to think about other options: They require physicians to fill out forms — like the one that landed on Dr. Lindenberg’s desk — and move the drug to a category that requires larger patient co-pays.

If markets function, the current high price of digoxin might induce some more drug companies to begin selling it, which should in turn bring prices back down. But a few years of higher bills could be a strain for older patients, most of them on Medicare, who must contribute to prescription drug costs.

Antoinette Newell, 85, said she was shocked when her co-pay for digoxin suddenly jumped this year to $30 a month from $1.15 for a three-month supply. She takes several other medicines as well.

A widow from Schenectady, she lives on $1,600 a month. “I was so upset, I at first told the pharmacist I didn’t want it,” she said about her digoxin refill. “But I know I need it. It’s the only pill that works for me.”

Recall: Undeclared Drug Found in Supplement to Treat High Cholesterol
07/11/2014 11:47:47

Recall: Undeclared Drug Found in Supplement to Treat High Cholesterol

Doctor’s Best Red Yeast Rice has been found to contain undeclared lovastatin, which makes the product an unapproved drug. Lovastatin is a prescription drug for the treatment of high cholesterol. As a result Doctor’s Best is recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles.

Doctor’s Best Red Yeast Rice was distributed nationwide through retail and internet outlets. The product is marketed as a dietary supplement for lowering cholesterol and is packaged in white plastic bottles with an orange flip-top lid, and a clear tamper-evident outer seal. UPC code 753950001183 and expires February 2017.

Risk:Consumers who use supplements found to contain lovastatin in rare cases could experience serious muscle injury, particularly if taking with prescription “statins” such as lovastatin, simvastatin, or atorvastatin. Statins are a class of drug commonly used to lower cholesterol. Patients with pre-existing liver disease may be at an increased risk for liver injury following chronic use of statins.

Recommendations

  • Consumers should stop using any product with lot number 3121005.
  • Consumers with questions regarding this recall can contact Doctor’s Best at 1-844-717-0190 Mon. – Fri. 9 a.m. until 5 p.m. PT.
  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
FDA Warns about Undeclared Drugs Found in Weight Loss Product
07/10/2014 11:51:18

FDA Warns about Undeclared Drugs Found in Weight Loss Product

FDA is advising consumers not to purchase or use La Jiao Shou Shen, a product promoted and sold for weight loss. The product has been found to contain undeclared phenolphthalein, sibutramine or a combination of both, which makes it an unapproved drug. Sibutramine is a controlled, FDA-approved substance for the treatment of obesity. Sibutramine was removed from the U.S. market in 2010 for safety reasons. Phenolphthalein, once used in over-the-counter laxatives, is not approved for marketing in the U.S. because of concerns that the substance can cause cancer.

Risk: Products containing sibutramine pose a threat to consumers because the drug substantially increases blood pressure and pulse rate in some patients. These products may pose a significant risk to those with a history of coronary artery disease, congestive heart failure, abnormal heart rhythm or stroke. These products may also interact badly with medications the consumer may be taking. Consumption of these pills could also cause potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Recommendations

  • Consumers should stop using this product immediately.
Know the Risks of Feeding Raw Foods to Your Pets
07/02/2014 12:24:44
FDA’s Advice: Know the Risks of Feeding Raw Foods to Your Pets

Food poisoning isn’t only a human problem: our four-legged friends are also at risk if they eat foods that are contaminated with disease-causing bacteria. Two of these bacteria—Salmonella and Listeria monocytogenes — are particularly dangerous to both pets and humans. Here is one way to avoid them—and why.

Knowing the Risk to Your Pet

Raw pet food consists primarily of meat, bones, and organs that haven’t been cooked, and therefore are more likely than cooked food to contain organisms that can make your dog or cat sick, says William J. Burkholder, DVM, PhD, Veterinary Medical Officer in the Food and Drug Administration’s (FDA’s) Division of Animal Feeds. Moreover, raw food can make you sick as well if you don’t handle it properly. FDA does not believe feeding raw pet foods to animals is consistent with the goal of protecting the public from significant health risks.

The agency therefore recommends cooking of raw meat and poultry to kill harmful bacteria like Salmonella and Listeria monocytogenes before you give the food to your pets. And as always, when working with food, you should follow FDA’s instructions on how to handle it safely.

Salmonella bacteria are commonly found in such foods as raw or undercooked meat, poultry, eggs and egg products. Salmonella can also contaminate raw or unpasteurized milk and other dairy products, as well as raw fruits and vegetables.

Burkholder says people who choose a raw diet for their pets often point out that feral dogs and cats catch prey and eat it raw. “That’s true,” he adds, “but we don’t know how many of these animals get sick or die as a result of doing that. Since sick feral animals are rarely taken to a veterinarian when they’re ill, there’s no way to collect that information.”

Symptoms of salmonellosis in animals include:

  • Vomiting
  • Diarrhea (which may be bloody)
  • Fever
  • Loss of appetite
  • Decreased activity level

Listeria bacteria are commonly found in uncooked meats, vegetables and unpasteurized milk and soft cheeses. Unlike most bacteria, Listeria like cold temperatures and can grow and spread in the refrigerator. So if you refrigerate Listeria-contaminated food, the germs not only multiply at the cool temperature, they could contaminate your refrigerator and spread to other foods there, increasing the likelihood that you and your family members would be exposed to Listeria and get sick.

Symptoms of listeriosis in animals include:

  • Nausea
  • Diarrhea
  • Fever
  • Neurological disease can happen in a small percentage of situations

Raw Foods Can Also Affect Human Health

Consumers also run the risk of getting sick if they handle contaminated pet foods and accidentally transfer the bacteria to their mouths.

“If you’re going to handle raw foods, you need to pay particular attention to good hygienic practices,” Burkholder says. “Wash your hands and anything else that comes into contact with the product with hot, soapy water for at least 20 seconds.”

Feeding raw food to a pet also increases the risk of contaminating food contact surfaces and other places.

“Even if the dog or cat doesn’t get sick, they can become carriers of Salmonella and transfer the bacteria to their surroundings, and then people can get the disease from contact with the infected environment,” Burkholder says.

Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.

Symptoms of Salmonella and Listeria Infection in Humans

Salmonella infection (salmonellosis) symptoms in humans include:

  • Fever
  • Nausea
  • Vomiting
  • Diarrhea (which may be bloody)
  • Stomach pain
  • More rarely: entry of Salmonella into bloodstream from intestines, followed by spread to joints, arteries, heart, soft tissues, and other areas of body

Symptoms associated with salmonellosis most often begin 12 hours to 3 days after ingestion of the bacteria and can last 4 to 7 days without treatment. All consumers are at risk for contracting salmonellosis from contaminated foods, but pregnant women, children under five, the elderly and those with weak immune systems are at risk of developing severe symptoms.

Compared to salmonellosis and other foodborne illnesses, infection with Listeria monocytogenes (listeriosis) is rare, but has serious and potentially fatal risks.

Listeria can infect multiple locations in the body:

  • The brain
  • Membranes surrounding the brain and spinal cord
  • Gastrointestinal tract
  • Bloodstream

Symptoms associated with listeriosis begin 11 to 70 days after coming in contact with the bacteria, with a mean (or average) of 31 days, and they can last up to a few weeks. Listeriosis occurs almost exclusively in pregnant women and their fetuses, newborns, the elderly and those with weak immune systems. Listeriosis can cause life-threatening infection in a fetus and newborns, as well as in persons with weakened immune systems, although the infection can often be treated with antibiotics.

“Feeding raw foods to pets increases the risk that both the pet and the people around the pet will encounter bacteria that cause foodborne illness, particularly if the products are not carefully handled and fed,” Burkholder says. “This is certainly one factor that should be considered when selecting diets for your pet.”

A Scam-Free Vacation
06/28/2014 11:52:48
A Scam-Free Vacation

Heading out of town? Make sure you come back with a nice post-vacation glow and not a case of identity theft. Here are some things you can do to lessen the chances you’ll be a victim.

Limit what you carry. Take only the ID, credit cards, and debit cards you need. Leave your Social Security card at home. If you’ve got a Medicare card, make a copy to carry and blot out all but the last four digits on it.

Know the deal with public Wi-Fi. Many cafés, hotels, airports, and other public places offer wireless networks — or Wi-Fi — you can use to get online. Two things to remember:

  • Wi-Fi hotspots often aren’t secure. If you connect to a public Wi-Fi network and send information through websites or mobile apps, the info might be accessed by someone it’s not meant for. If you use a public Wi-Fi network, send information only to sites that are fully encrypted (here’s how to tell), and avoid using apps that require personal or financial information. Researchers have found many mobile apps don’t encrypt information properly.
  • That Wi-Fi network might not belong to the hotel or airport. Scammers sometimes set up their own “free networks” with names similar to or the same as the real ones. Check to make sure you’re using the authorized network before you connect.

Protect your smartphone. Use a password or pin, and report a stolen smartphone — first to local law enforcement authorities, and then to your wireless provider. In coordination with the Federal Communications Commission (FCC), the major wireless service providers have a stolen phone database that lets them know a phone was stolen and allows remote “bricking” so the phone can’t be activated on a wireless network without your permission. Find tips specific to your operating system with the FCC Smartphone Security Checker at fcc.gov.

ATMs and gas stations — especially in tourist areas — may have skimming devices. Scammers use cameras, keypad overlays, and skimming devices — like a realistic-looking card reader placed over the factory-installed card reader on an ATM or gas pump — to capture the information from your card’s magnetic strip without your knowledge and get your PIN. The FBI offers tips to avoid being scammed by a skimmer.

Watch that laptop. If you travel with a laptop, keep a close eye on it — especially through the shuffle of airport security — and consider carrying it in something less obvious than a laptop case. A minor distraction in an airport or hotel is all it takes for a laptop to vanish. At the hotel, store your laptop in the safe in your room. If that’s not an option, keep your laptop attached to a security cable in your room and consider hanging the "do not disturb" sign on your door.

Still, despite your best efforts to protect it, your identity may be stolen while you’re traveling. Here’s what you can do.

Breast Cancer - Men Get It Too
06/27/2014 11:54:26
Breast Cancer - Men Get It Too

Breast cancer is a disease usually associated with women, as reflected by pink ribbons and gear, but men get it too, albeit rarely.

Because male breast cancer is rare, the Food and Drug Administration (FDA) doesn’t have very good clinical trial data on treatments. “We tend to treat men the same way we treat women,” says Tatiana M. Prowell, MD, a medical oncologist and breast cancer scientific lead at FDA’s Office of Hematology & Oncology Products.

“Men have historically been excluded from breast cancer trials,” she adds. “We are actively encouraging drug companies to include men in all breast cancer trials unless there is a valid scientific reason not to. The number of men in breast cancer trials will still be small because male breast cancer is a rare condition, but any information to help men facing this disease is better than none.”

Men vs. Women

Each year, about 2,000 cases of male breast cancer (1% of all cases) are diagnosed in the United States, resulting in fewer than 500 deaths, according to the National Cancer Institute. Although it can strike at any age, the disease is usually diagnosed in men 5 to 10 years older than in women and is found most often among men ages 60 to 70.

Prowell says one reason for the late-age (and later stage) diagnosis may be that men don’t think of themselves as being at risk of breast cancer. “You’d think that because men have smaller breasts they would notice a lump instantly,” Prowell says. “But men don’t expect a breast lump to be cancer, whereas most women who feel a breast lump immediately assume the worst.”

Most men with breast cancer have painless lumps they can feel. The lumps can develop anywhere on the breast but often are underneath the nipple and areola complex—right in the center. Because men don’t have regular mammograms, their breast cancer is usually discovered when they feel sore, such as from a fall or injury.

“Men often attribute breast lumps to some sort of injury. The mass was already there, but they didn’t notice it until it got sore,” Prowell says.

Men and women share some similar risk factors for breast cancer: high levels of estrogen exposure, a family history of the disease and a history of radiation to the chest. Although all men have estrogen in their bodies, obesity, cirrhosis (liver disease) and Klinefelter’s syndrome (a genetic disorder) increase estrogen levels. All are known risk factors for male breast cancer.

If a first-degree relative—their mother, father, brother, sister, children—has breast cancer, men are also at slightly higher risk to develop the disease themselves. Men who have a BRCA mutation (a mutation or change in a gene that predisposes them to breast cancer) are at a greater risk. While their chance of developing breast cancer is still low (only about 5% to 6%), men with a mutation in BRCA2 have a 100-fold greater risk of developing breast cancer than men in the general population.

“In men and women, having a tumor with estrogen and progesterone hormone receptors is more common than not—but that appears to be even more true in men,” Prowell adds.

Treating Male Breast Cancer

Treatment options for men are similar to women’s: mastectomy (surgery to remove the breast) or in some cases lumpectomy, radiation, chemotherapy, targeted therapies and hormone therapy.

“Our data on treatments for men are largely based from trials that were conducted in women, or they are retrospective data from a collection of men who were treated over a period of time. We don’t have large randomized trials or high-level evidence for treatment of breast cancer in men as we do for women,” Prowell says.

Hormonal drug treatments include tamoxifen, a selective estrogen receptor modulator (SERM) that inhibits estrogen receptors, and aromatase inhibitors, which block the production of estrogen from androgens such as testosterone.

“For postmenopausal women, we preferentially use aromatase inhibitors as first-line treatment for early stage breast cancer, and regard tamoxifen as an alternative. It’s the opposite for men because what data we have suggest that aromatase inhibitors don’t work as well in men. So for men, aromatase inhibitors are usually an alternative or second-line treatment, after tamoxifen,” Prowell says.

For men with larger tumors, positive lymph nodes or cancer that has spread, chemotherapy is often recommended in addition to hormonal treatment, just as it is for women. And men with tumors that are HER2-positive are recommended to receive treatment with trastuzumab, an antibody that targets HER2, just as women are.

Genetic Counseling Is a Must

All men with breast cancer should be referred for genetic counseling, Prowell advises.

That’s another difference from women, who are not automatically referred to a genetic counselor for genetic testing, such as for mutations in BRCA-1 or 2. These “tumor suppressor genes” allow breast and other types of cancer to develop when they fail to function normally. Only women with a significant family history or certain other characteristics, such as being young or having triple-negative breast cancer (which don’t have estrogen, progesterone or HER2 receptors), are recommended to have genetic testing.

Even among men there are differences. African American men are more likely than white men to have advanced stage tumors at diagnosis and to develop triple-negative cancers. Their types of tumors are more likely to recur and have fewer treatment options.

People should tell their health care provider if any man in their family has had breast cancer. Prowell says. “Even if your grandfather is deceased, if he had breast cancer, that’s important for your health care provider to know. Because male breast cancer is so rare, seeing just one man in a family lineage raises concerns about hereditary breast cancer.”

Blood Pressure Monitoring Kiosks Aren
06/26/2014 08:28:18
Blood Pressure Monitoring Kiosks Aren't for Everyone
Convenience can come with tradeoffs. The next time you put your arm in the cuff at a kiosk that measures blood pressure, you could get an inaccurate reading unless the cuff is your size.

Correct cuff size is a critical factor in measuring blood pressure. Using a too-small cuff will result in an artificially high blood pressure reading; a too-large cuff may not work at all or result in an inaccurately low blood pressure reading. The Food and Drug Administration (FDA) is advising consumers that blood pressure cuffs on public kiosks don’t fit everyone and might not be accurate for every user.

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These desk-like kiosks for checking blood pressure are available in many public places—pharmacies, grocery and retail stores, gyms, airports, hair salons and even cafeterias. “They are easily accessible and easy to use. But it’s misleading to think that the devices are appropriate for everybody. They are not one-size-fits-all,” says Luke Herbertson, PhD, a biomedical engineer at FDA.

Cuff Size Matters

Blood pressure is an important indicator of cardiovascular health. High blood pressure (hypertension) is called a “silent killer” because it may not show any symptoms. It increases the risk of stroke, heart attack, heart failure, kidney failure and death. The higher the blood pressure, the greater the risk. Hypertension affects nearly one in three adults in the United States, and in most patients, it is found only when they have their blood pressure checked.

In a clinic or a medical office, this is done by using blood pressure cuffs of various sizes to ensure the reading is accurate. For example, a toddler’s blood pressure is checked by using an extra-small children’s cuff, but a football lineman’s arm may require an extra-large adult cuff.

Not so at kiosks. Most have just one fixed-size cuff that fits arms of only a certain size. The blood pressure reading is reliable only if the user’s arm is within the range that has been validated for that cuff size. Moreover, not all kiosks have the same size cuff. There is no such thing as a “standard” cuff to fit a “standard” arm.

Why does that matter? Correct cuff size is a critical factor when measuring blood pressure. If the cuff doesn’t fit your arm properly, your reading won’t be accurate.

“Different kiosks have different cuff sizes that will fit different people—so it’s important to know the circumference of your upper arm because not all devices are alike,” says Stephen Browning, a biomedical engineer at FDA. “Many people will be outside the arm size range for a particular kiosk, and the information from that kiosk won’t be reliable for them.”

Other factors, including how someone uses a device, might cause an inaccurate reading. “The user might not have placed the cuff on his arm properly or might not be sitting properly. These things will affect accuracy,” Herbertson says.

That’s why people shouldn’t overreact to any one reading from a kiosk.

“Hypertension isn’t diagnosed solely based on one reading. Inaccurate blood pressure measurements can lead to the misdiagnosis of hypertension or hypotension (low blood pressure), and people who need medical care might not seek it because they are misled by those inaccurate readings,” Browning says.

“Next time you see your doctor, get his or her opinion about whether blood pressure kiosks are right for you and if so, learn to use them properly—using the right size cuff so you can get accurate readings,” Herbertson advises.

Advice for Consumers

Consumers use kiosks for various reasons. They might have been advised by their doctor to monitor changes to their health. They may be concerned about hypertension. Or they may just be curious about their blood pressure.

Health care providers diagnose hypertension based on several blood pressure measurements over a period of time. Remember that one measurement—from a kiosk or other device—doesn’t a diagnosis make.

Like your heart rate, your blood pressure can change quickly. It might be higher during a stressful meeting, after a brisk walk or because you’re sick. Those variations are normal. That’s why people with hypertension monitor their blood pressure frequently. And health care providers often depend on the patient’s own readings to augment the reading in a doctor’s office, so kiosks can be useful in many circumstances.

Although blood pressure kiosks have their limitations, they can provide valuable information when used properly and under the guidance of a health care provider.

Safe Use of Flea and Tick Products in Pets
06/23/2014 13:17:57
Safe Use of Flea and Tick Products in Pets

Fleabites may be more than an itchy annoyance to some dogs and cats. They can cause flea allergy dermatitis—an allergic reaction to proteins in flea saliva. And a pet’s constant scratching can cause permanent hair loss or other skin problems. Fleas feasting on your pet’s blood can lead to anemia and, in rare cases, death.

Ticks can also harm your pet, transmitting infections such as Lyme disease. And pets can bring ticks into the home, exposing you and your family to illness from a tick bite.

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Hundreds of pesticides, repellents, and growth inhibitors are available to protect your pet from flea and tick bites. Some of these products are available only from a veterinarian; others can be bought over the counter.

Flea and tick products range from pills given by mouth to collars, sprays, dips, shampoos, powders, and “spot-ons,” liquid products squeezed onto the dog’s or cat’s skin usually between the shoulder blades or down the back. A few spot-on products are available for flea control in ferrets, and fly and tick control in horses.

Pet owners need to be cautious about using flea and tick products safely, says Ann Stohlman, V.M.D., a veterinarian in the Food and Drug Administration’s (FDA) Center for Veterinary Medicine. “You need to take the time to carefully read the label, the package insert, and any accompanying literature to make sure you’re using the product correctly.”

Regulation of Flea and Tick Products

Flea and tick products for pets are regulated by either FDA or the Environmental Protection Agency (EPA).

FDA is responsible for regulating animal drugs; however, some products to control external parasites come under the jurisdiction of EPA. FDA and EPA work together to ensure adherence to all applicable laws and regulations. In general, flea and tick products that are given orally or by injection are regulated by FDA.

Before an animal drug is allowed on the market, FDA must “approve” it. Before a pesticide can be marketed, EPA must “register” it.

Both agencies base their decision on a thorough review of detailed information on the product’s safety and effectiveness provided by the manufacturer or other product sponsor. The sponsor must show that the drug or pesticide meets current safety standards to protect

  • the animal
  • people in contact with the animal
  • the environment

The sponsor must also show that the drug or pesticide produces the claimed effect, and the product must carry specific labeling so that it can be used according to the directions and precautions.

After a product is allowed on the market, manufacturers are required by law to report any side effects of their flea or tick products to the regulating agency.

Caution with Spot-On Products

In spring 2009, EPA noticed an increase in pet incidents being reported involving spot-on pesticide products for pets. EPA received a large amount of bad pet reaction information reported to the companies that hold registrations for these products. EPA formed a veterinarian team with the Food and Drug Administration’s Center for Veterinary Medicine (CVM) and Canada’s Pest Management Regulatory Agency (PMRA) to review this information. The team studied incidents involving cats and dogs, looked at the ingredients, studied labeling, and discussed data needs for the future to improve analyses and regulation.

Based on its analysis, EPA determined that some changes need to be made in how spot-on products are regulated, how companies report data on pet incidents, and how packages are labeled for cats, dogs, and size of animals to ensure the safety of these products. Based on reported incidents, EPA also concluded that many but not all pet incidents took place because the products were misused.

In September 2011, EPA required the following actions in response to the analysis of spot-on treatments:

  • Requiring manufacturers of spot-on pesticide products to improve labeling, making instructions clearer to prevent product misuse, including repeating the word “dog” or “cat” and “only” throughout the directions for use and applicator vial, and detailed side effect language.
  • Requiring clear marking to differentiate between dog and cat products and more precise label instructions to ensure proper dosage per pet weight.
  • Restricting the use of any inert ingredients that EPA finds may contribute to incidents.
  • Launching a consumer information campaign to explain new label directions and to help users avoid making medication errors.

Spot-on flea and tick products can be effective treatments, and many people use the products with no harmful effects to their pets. EPA does not advise pet owners to stop using spot-ons, but asks them to use caution and make informed decisions when selecting treatment methods.

EPA advises pet owners to

  • carefully follow label directions and monitor their pets for any signs of a bad reaction after application, particularly when using these products for the first time
  • talk to a veterinarian about responsible and effective use of flea and tick products

When to Treat

It's best to treat your pet at the beginning of flea and tick season, says Stohlman. The length of flea season, which peaks during warm weather months, varies depending on where you live. “It can last four months in some places, but in other places, like Florida, fleas can live all year long,” says Stohlman. And fleas can live inside a warm house year-round no matter where you live.

Ticks are found in some places year-round. The Centers for Disease Control and Prevention report that in most parts of the United States, the greatest chance of infection by a tick bite is spring and summer.

Tips for Using Flea and Tick Products

  • Read the label carefully before use. If you don't understand the wording, ask your veterinarian or call the manufacturer. “Even if you’ve used the product many times before,” says Stohlman, “read the label because the directions or warnings may have changed.”
  • Follow the directions exactly. If the product is for dogs, don't use it on cats or other pets. If the label says use weekly, don't use it daily. If the product is for the house or yard, don't put it directly on your pet.
  • Keep multiple pets separated after applying a product until it dries to prevent one animal from grooming another and ingesting a drug or pesticide.
  • Talk to your veterinarian before using a product on weak, old, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown signs of sensitivity to flea or tick products.
  • Monitor your pet for side effects after applying the product, particularly when using the product on your pet for the first time.
  • If your pet experiences a bad reaction from a spot-on product, immediately bathe the pet with mild soap, rinse with large amounts of water, and call your veterinarian.
  • Call your veterinarian if your pet shows symptoms of illness after using a product. Symptoms of poisoning include poor appetite, depression, vomiting, diarrhea, or excessive salivation.
  • Do not apply a product to kittens or puppies unless the label specifically allows this treatment. Use flea combs to pick up fleas, flea eggs, and ticks on puppies and kittens that are too young for flea and tick products.
  • Wash your hands immediately with soap and water after applying a product, or use protective gloves while applying.
  • Store products away from food and out of children's reach.

Source: FDA and CDC

Reporting Problems

Keep the product package after use in case side effects occur. You will want to have the instructions available, as well as contact information for the manufacturer.

  • To report problems with spot-on flea or tick products, contact the National Pesticide Information Center (NPIC) at 1-800-858-7378.
  • To report problems with FDA approved flea or tick drug products, contact the drug manufacturer directly (see contact information on product labeling) or report to FDA's Center for Veterinary Medicine on a Form FDA 1932a.
  • If your pet needs immediate medical care, call your local veterinarian, a local animal emergency clinic, or the National Animal Poison Control Center at 1-888-426-4435. The NAPCC charges a fee for consultation.
Hackers Score a Goal with World Cup Scams
06/18/2014 17:23:28

Hackers Score a Goal with World Cup Scams

Last Thursday, the world jumped into the World Cup—the premier celebration of soccer (or football, depending on where you call home). It’s an exciting time for sports fans, but it’s also a perfect time for criminals to peek into the pockets, both virtual and otherwise, of vulnerable spectators.

Large sporting events like the Olympics, the Super Bowl and, of course, the World Cup, tend to draw a lot of money for security. But most of that money is spent beefing up the physical security in and around the games. Some sporting events, such as the Olympics, try to protect visitors from both political and financial attacks, but there’s little event organizers can do when strangers to a new country do what they do best—wander.

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And it’s that wandering that hackers hope for. A destination sporting event can easily be ruined when travelers connect to a malicious network at a nearby pub or coffee shop, access a compromised automated teller machine (ATM), or try to take advantage of fantastic online deals for an event—only to find out it was a scam. And be careful performing an online search for Cristiano Ronaldo or Lionel Messi—two of the most popular soccer players in the world. They top our list of the riskiest soccer/football players on the web, meaning that their names are commonly used by hackers to draw fans to malicious websites.

For tourists and sports travelers, especially those currently at the World Cup, the burden of digital security at large events falls on you, the visitor.

So what can you do to stay protected when you attend or attempt to live stream the World Cup? Well you’ve got a few options:

  • Be leery of “free.” When you see links, emails, or online ads offering free game highlights, free streaming bundles, and free athlete-tracking software, you could be signing up for free malware. Hackers turn to this tried and true method to trick their victims into downloading malicious software onto their computers. If something looks too good to be true, it probably is.
  • Avoid logging into sensitive websites over public Wi-Fi. Avoid using public Wi-Fi both at home and abroad, as it’s typically insecure. If you must use public Wi-Fi, avoid logging into any sensitive accounts such as your bank. You should also avoid conducting any online transactions where your credit card information must be entered. Hackers may be monitoring networks in an effort to snatch your credentials out of the air.
  • Protect your devices with comprehensive security software. The best way to protect yourself in any location is to use a security program that’s built to protect you.

 

“My Medicines” ... This Brochure Can be a Lifesaver
06/17/2014 13:36:25

“My Medicines” ... This Brochure Can be a Lifesaver

Can carrying around a brochure help save your life? Yes, if it's the “My Medicines” brochure offered by FDA’s Office of Women's Health (OWH). It’s designed to help consumers track the medications they use.

My Medicines features a chart that allows you to list information about your prescription medicines, including the names of the medicines, how much you take, when you take them, what condition they are treating, and the number of refills.

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The brochure also offers advice on how to use labeling information, how to avoid problems with your medicines, and questions you should ask your doctor or pharmacist about your prescriptions.

The brochure is available online at www.fda.gov/womenshealthsafemeds, as well as through the mail and from insurance providers, pharmacies, hospitals, health fairs, senior centers, and other venues.

Case History

Coral Thomas, a resident of Clarksville, Tenn., is particularly glad that she picked up a My Medicines brochure during a visit to her doctor.

Thomas filled out the brochure, and placed it in her purse. It was there to help her when, at age 66, she suffered a heart attack. “The heart doctor at the hospital told me that (filling out and keeping the brochure) was the smartest thing I could have done,” she reported.

Seeing that Thomas was taking daily treatments for high blood pressure and other conditions, the doctor changed his treatment plan. He later told Thomas he wished that every patient would carry such a list because it helps caregivers know the best way to proceed.

After her recovery, Thomas ordered dozens more My Medicines brochures and distributed them to her friends. “It’s just the best thing to have,” she says. “Women should carry one in their purses and keep a spare in their cars. Believe me, it can save your life.”

Of course, the brochure can prove helpful to men as well.

Take Time to Care

My Medicines, which is available in 14 languages, is part of an outreach initiative called “Take Time to Care” (TTTC), which was launched by OWH in 1998 to provide reliable, science-based health information. Millions of My Medicine brochures have been distributed since the program’s launch.

OWH now offers more than 40 easy-to-read publications that include fact sheets and medication booklets. These free materials are also available in many languages and can be downloaded at www.fda.gov/womenshealthpubs.

FDA Takes Final Step on Infant Formula Protections
06/09/2014 17:32:21

FDA Takes Final Step on Infant Formula Protections

The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them.

In keeping with that mission, FDA announced on June 9, 2014 that it is finalizing a rule—first published as an interim final rule on February 10, 2014—that sets standards for manufacturers of infant formula. In light of comments received after the interim rule published, the final rule provides some modifications and clarifications, and sets a date of September 8, 2014 for manufacturer compliance.

Under the final rule, standards include:

  • Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
  • A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth.
  • A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.

“FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development,” says Stephen Ostroff, M.D., FDA’s acting chief scientist.

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. The agency notes that many companies now manufacturing infant formula for the U.S. market have been producing safe products and have voluntarily applied many of the current good manufacturing practices and quality control procedures included in the final rule. But this rule will set in place federally enforceable requirements for the safety and quality of infant formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Lookout for timeshare resale phonies
05/14/2014 19:28:40

Be on the lookout for timeshare resale phonies

May 14, 2014

The FTC and state consumer protection agencies have shut down dishonest timeshare resellers for bilking timeshare owners out of millions of dollars. If you’re selling a timeshare, listen carefully for the promise of lots of money quickly and a request for an upfront fee. Those are two key signs of timeshare resale scam — and someone you don’t want to do business with.     

In one recent case, Vacation Property Services claimed to represent big-name companies eager to buy timeshares for business travel and events. The company guaranteed timeshare owners hefty returns if they moved quickly on the offer. But first, the company said the owner had to pay from $500 to $2,000, via credit card, in “registration” and other fees to seal the deal.

Timeshare Resale Scams Infographic

Timeshare Resale Scams
Infographic

The company’s promises of ready buyers, fast sales, big profits and money-back guarantees turned out to be lies. What’s more, the timeshare owners were stuck with debt on their credit cards from paying the “fee” after the company told them that the sale would be complete — and that they’d have their money — by the time the credit card bill came.

If you own a timeshare, question any offers to help you resell it. Be skeptical of companies that:

  • claim the market in your area is “hot” and that they’re “overwhelmed” with buyer requests
  • say they have buyers ready to purchase your timeshare — or promise to sell your timeshare within a specific time
  • guarantee you’ll get big returns on your resale
  • require you to pay fees upfront — even if there’s the promise of a “money-back guarantee”
  • don’t provide a contract — or provide a contract that doesn’t accurately reflect conversations you had   

Read about buying and selling a timeshare, or check out our infographic to see how timeshare resale scams typically work.

Lights Out For Fake Utility Bill Collectors
05/09/2014 17:24:15

Lights out for fake utility bill collectors

May 9, 2014

The caller sounds convincing: If you don’t pay your utility bills immediately, your gas, electricity or water will be shut off. They ask you to pay using a specific — and unusual — method.

Be warned: The call probably is a trick to steal your money.

The Federal Trade Commission, state and local consumer protection agencies, and utility companies have gotten a slew of complaints from consumers about utility bill scams. Here are a few signs you may be dealing with a scammer:

  • You get a call or an email claiming your services will be cut off unless you call a number or click on a link and give your account information. Most utility companies don’t ask you to send your account information by email.
  • Someone calls demanding you wire the money or use a prepaid or reloadable debit or gift card to pay your bill. Legitimate companies don’t demand you use those methods to pay.  
  • The caller tells you to call a phone number and give your credit, debit or prepaid card number. But if you do that, the scammer can access the money from your credit, debit or prepaid card, and you can’t trace where your money went. Once it’s gone, it’s gone.

So if you get a call from someone threatening to shut off your utility service:

  • Make sure you’re dealing with your utility company before you pay any amount. Call the company using a number you’ve looked up. Or go to their website to determine the status of your account. Confirm where and how to pay your bill. Don’t give out your account information on the phone unless you place or expect the call.
  • Never wire money to someone you don’t know — regardless of the situation. Once you wire money, you cannot get it back.
  • Do not click links or call numbers that appear in unexpected emails or texts — especially those asking for your account information. If you click on a link, your computer could become infected with malware, including viruses that can steal your information and ruin your computer.
  • If you are falling behind on your utility bill, contact the utility company and see if they can work with you to come up with a payment plan and a way to keep your service on. 
  • If you think a fake utility bill collector or any other scammer has contacted you, file a complaint with the FTC and your state consumer protection agency.
Don’t get nailed by a home improvement scam
05/07/2014 17:27:03

Don’t get nailed by a home improvement scam

May 7, 2014

Spring has sprung, the grass is green, just watch out for scammers selling home improvement dreams.

If you’re thinking about building a deck, getting new windows, redoing the kitchen (like me!), repaving the driveway, or adding a fresh coat of paint to your home’s interior, it might makes sense to hire a pro rather than take on the job yourself. Finding a good contractor is important — a home improvement project gone wrong can cost you big time. Choosing the wrong contractor can cost you more than money; it can lead to delays, subpar work, and even legal problems.

Before you hire a contractor, get several estimates and ask plenty of questions, including:

How many projects like mine have you completed in the last year? Will my project require a permit? What types of insurance do you carry? And be sure to get a written contract. Contract requirements vary by state. Even if your state doesn’t require a written agreement, ask for one. It should be clear and concise and include the who, what, where, when, and cost of your project.

How can you tell if a contractor might not be reputable? You may not want to do business with someone who: knocks on your door for business, just happens to have materials left over from a previous job, pressures you for an immediate decision, only accepts cash, asks you to pay everything up-front, or asks you to get the required building permits.

For more around-the-house tips, check out Home Improvement.

Callers target timeshare owners for a second scam
05/01/2014 17:29:32

Callers target timeshare owners for a second scam

May 1, 2014

In June 2013, the FTC sued several companies that scammed timeshare owners. The companies claimed they had interested buyers for timeshare properties. In fact, if timeshare owners paid, they found out there was no buyer — and they couldn’t get a refund.

Now, somebody is trying to rip off those timeshare owners again. Several people who previously paid Resort Solution Trust have reported to the FTC that someone recently called them claiming to be an attorney working on a case against the company. The caller said the timeshare owner was eligible for a refund, generally $1,000-$4,000 — if they first paid a “bond” or “fee,” around $800.

It’s a refund scam, designed to get more money from people who lost money from the original timeshare resale scam. People who pay will lose more money.

If you know anyone who lost money to a timeshare resale scam, please let them know that scammers may call claiming to get their money back if they pay a fee. When the FTC is able to refund money to people who have been scammed, the agency never requires them to pay. If you get such a call, report it to the FTC; indicate the name of the timeshare reseller.


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