Entries in Food and Drug Administration (30)


Wary Doctors Put the 'Wait' in Weight Loss Drugs

iStockphoto/Thinkstock(NEW YORK) -- After a 13-year dry spell, the U.S. Food and Drug Administration has approved two new drugs promising weight loss in a pill.  But will you be able to get a prescription for them?

The answer may depend on which doctor you see.

"I'll probably take a wait-and-see attitude myself," said Greg Anderson, an assistant professor of family medicine at the Mayo Clinic.  "The track record has not been particularly good for diet medications."

By contrast, Dr. Albert Levy, assistant professor of medicine at the Mount Sinai School of Medicine, said he has already been prescribing the same combination of drugs in the newest offering off-label for two years, a decision based on data from previous clinical trials.  He said almost all of his patients lost weight when they were given the medications.

"Once the patient has learned how to control the appetite and has lost a good amount of weight, she or he is stimulated to continue to lose weight without the medications," Levy said.

The two medications in question are Belviq and Qsymia.  Belviq, which contains a new medication called lorcaserin, was approved on June 27.  Qsymia, approved earlier this week, is a combination of two medications which had already been on the market, phentermine and topiramate.

In trials, patients taking Belviq lost about 5 percent of their total weight, while studies showed those on Qsymia lost about 10 percent of their weight.  The results aren't dramatic, but many are hopeful that these medications will help millions of Americans deal with obesity and related conditions like heart disease, hypertension and diabetes.

Investors are banking on these drugs too.  The U.S. weight loss market is estimated to be worth more than $60 billion per year.  Stocks for manufacturers of both drugs jumped at the news of the drugs' approval.  Analysts predict that Belviq and Qsymia sales can reach $1 billion annually.

But that's only if doctors prescribe them.  Ultimately, primary care physicians will be the gatekeepers who determine the fate of these medications.  Will they turn to a simpler remedy for obesity than urging their patients to eat right and exercise?  Or will they view these medications as more trouble than they're worth?

"I will predict that neither will be on the market in five years," said Dr. Lee Green, professor and chair of family medicine at the University of Alberta.  They really just don't do that much.  'Up to 10 percent weight loss' sounds great, until you look closely. That's when used by selected volunteer patients in carefully designed, closely monitored clinical trials. We'll be lucky to get half that in the real world."

Copyright 2012 ABC News Radio


Prescriptions for ADHD Drugs Increasing, Says New FDA Research

Comstock/Thinkstock(WASHINGTON) -- The number of children who received prescriptions for drugs used to treat attention deficit hyperactivity disorder (ADHD) increased over an eight-year period while the number of antibiotic prescriptions declined, according to a new study by the Food and Drug Administration.

Using a large national database, FDA researchers analyzed prescription drug trends among children up to age 17 between 2002 and 2010 on an outpatient basis.

The study, published in the journal Pediatrics, found that the number of overall prescriptions for this age group decreased by 7 percent, in contrast to the 22 percent increase in prescriptions given to adults over the same period.  However, the authors noted that their research did not track whether the drugs were actually used, only that they were prescribed.

There were also significant decreases in the number of antibiotics, allergy medicines, pain medicines, drugs used to treat depression and certain cough and cold medications prescribed for children. But ADHD prescriptions increased by 46 percent, and there were also higher numbers of medications prescribed for asthma and birth control.

"Identification of drugs with the highest numbers of patients exposed can help focus research efforts on those drugs that could have a large impact on the pediatric population, " wrote the authors, led by Grace Chai of the FDA's Center for Drug Evaluation and Research.

Contraceptive prescriptions also skyrocketed, increasing among adolescents by 93 percent. The study did not offer in-depth analysis of reasons behind these trends, but the authors did suggest that birth control use could actually be explained by a number of factors.  Recent surveys did not find much of an increase in the number of girls using birth control, so the trend may be the result of longer use or using these medications for other reasons, such as acne.

They also found that a considerable number of infants less than 1 year old were prescribed acid reflux-controlling proton pump inhibitors -- particularly Prevacid -- although these medications are not FDA-approved for use in children this young.

On the other hand, antibiotic use decreased by 14 percent, and the authors suggest that large-scale efforts by the American Academy of Pediatrics and other children's health experts to decrease antibiotic use "by educating parents about the futility of treating viral infections with antibiotics and about concerns of antibiotic resistance" have been successful.

Similarly, the number of antidepressant prescriptions for children declined.

Copyright 2012 ABC News Radio


US Has Drug Recall Problem, Study Says

Comstock/Thinkstock(BOSTON) -- Drug recalls in the U.S. happen frequently -- about once every month -- according to researchers at Brigham and Women’s Hospital in Boston.

In a new study published Monday in the Archives of Internal Medicine, the researchers found that although the U.S. Food and Drug Administration has systems for communicating these recalls, they might not be enough to warn health care providers of important drug recall information.

Researchers also found that the FDA issued official public notices for only about half of the recalls deemed the most serious, called Class I recalls.

”The FDA offers this communication service, and we anticipate that a lot of providers may rely on it and in doing so may not be getting the information they need when drugs are recalled,” said Joshua Gagne, an epidemiologist at Brigham and Women’s Hospital and one of the authors of the study.

Gagne and his colleagues analyzed eight years of data from the FDA’s Enforcement Reports and the archives of the agency’s two chief drug recall-reporting systems: the Recall Alert System and the FDA MedWatch Safety Alert database.  According to the study, FDA records show 1,734 drug recalls from 2004 to 2011; 91 of those recalls were tagged Class I recalls, meaning they had the greatest likelihood to cause patients serious harm, even death.

Of the 91 Class I recalls, the FDA issued official Recall Alert System notices for 55 of them.  For the remaining 36, half were reported through the FDA’s MedWatch system.  The remaining 18 Class I recalls were not communicated through either system.

Gagne also noted that the Recall Alert System is used also for recalls of products that have no bearing on patient care, such as veterinary drugs.

“It’s very possible that these important recalls are being lost in the less important ones,” Gagne said.

Responding to the article, FDA spokeswoman Sarah Clark-Lynn said the agency used many different methods of communicating information about drug recalls and safety, including email list serves, news releases, Twitter and text messaging.  And recalls, she said, were not up to the FDA alone.

“The recall system depends on full and open disclosure [by manufacturers], trust and the industry’s acceptance of its responsibilities to protect the public from violative products,” Clark-Lynn said in an email.

Gagne said the study didn’t look into how many times manufacturers notified physicians about drug recalls, which they frequently do via “Dear Doctor” letters sent directly to health care providers.

The researchers also found that drug recalls weren’t usually limited to a few pills here and there.  Of the Class I recalls from 2004 to 2011, 34 percent affected more than 100,000 units of a drug, and 64 percent of recalled drugs had been distributed nationwide.  Forty percent of the recalls were because of contaminated drugs, and 25 percent of the drugs were recalled for having the wrong doses or release mechanisms.  The rest were the result of product mix-ups or mislabeling.

Copyright 2012 ABC News Radio


FDA Issues Warning About Experimental Therapy

iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration has issued a warning about the potential risks of an experimental therapy used to treat a condition -- chronic cerebrospinal venous insufficiency, or CCSVI -- often linked to multiple sclerosis.

CCSVI is characterized by a narrowing of veins in the neck and chest, and some researchers believe that the narrowing can lead to some of the central nervous system inflammation that is a hallmark of multiple sclerosis.

"However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established," the FDA said in a news release.

CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as "liberation therapy," or a "liberation procedure," the agency said.

But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.

CCSVI was first identified in 2009 by Dr. Paolo Zamboni, an Italian vascular surgeon. He later tried inflating the veins using the balloon procedure in 65 patients and, despite the fact that the study was unblinded and had no placebo group, Zamboni found some improvement in MS symptoms among most of them.

Despite Zamboni's reported success, MS researchers in the U.S. said it's too soon to know for certain how -- and if -- CCSVI and MS are related. There have been many patients in the U.S. and Europe who have had CCSVI therapy, though not as part of any clinical trial. Feedback about the therapy, experts said, has been mixed.

"Some patients will say they've had improvement, and others will say there's been no symptom improvement," said Timothy Coetzee, chief research officer at the National Multiple Sclerosis Society. "We need to assess whether or not opening up veins has any beneficial effect in changing the course of the disease."

The CCSVI Alliance, a group dedicated to promoting education and research on CCSVI, says on its website that while it does not promote or deter against having CCSVI therapy, patients should make risk assessments based on their individual situation and by careful discussion with their doctor.

A clinical trial to assess the safety and efficacy of the treatment is about to get underway in Canada, and as research continues, so will the debate over CCSVI.

Copyright 2012 ABC News Radio


FDA Still Cautious About Bone Drugs

Peter Dazeley/Getty Images(NEW YORK) -- The U.S. Food and Drug Administration says doctors need to reassess which women are likely to benefit from popular bone-building drugs, given the lack of evidence showing that taking them for the long term really helps and the possibility that they put some women at risk for rare but serious side effects.

In a report published in the New England Journal of Medicine on Wednesday, the U.S. Food and Drug Administration raised concerns about the potential for some serious side effects in women taking bone-building drugs called bisphosphonates, specifically Fosamax, Actonel and Reclast.

The published findings are not new. In 2011, the agency voiced concerns that taking the drugs long-term may actually make bones weaker and increase the risk of rare but serious side effects such as atypical fractures of the thigh bone, esophageal cancer and osteonecrosis of the jaw, a rare but painful condition in which the jaw bone crumbles. To investigate, the FDA reviewed data from women who had taken the drugs for six to 10 years.

In Wednesday's report, the agency repeated its 2011 conclusions: Women without osteoporosis seem to get few to no benefits to their bones from taking the drugs beyond five years. In light of the concerns about the potential side effects, the authors said some patients should be able to safely stop taking the drugs after that time, particularly if they are younger and at low risk of fractures.

They suggested that women who continue to have very low bone density, measured by a "T score" lower than minus 2.5, are the ones who may benefit the most from taking the drugs after five years.

A commentary accompanying the FDA's report said it is older women who have a history of fractures or are at an increased fracture risk, particularly of spine fractures, who stand to benefit from taking the drugs for longer than five years.

Dennis Black, a professor of epidemiology at the University of California, San Francisco and the lead author of the commentary, said the drugs appear to be safe and helpful for women taking them for just few years at a time.

"These drugs in general have very strong proven benefits for the first five years," Black said. "I would want a patient with osteoporosis to not let the worry about these very rare side effects overwhelm the very strong benefits they would get."

The reports reflect overall uncertainty about the optimal length of time a patient should take these drugs. Clinical trials of bisphosphonates have studied large numbers of women for up to five years and have shown that the drugs are effective for that length of time. But the trials looking at the effects after five years have included a much smaller number of patients, meaning their results are less certain.

According to the FDA, doctors wrote more than 150 million prescriptions for bisphosphonates between 2005 and 2009. The drugs work by targeting the body's process of breaking down and regenerating bone cells. After age 30 or so, a woman's bones start to break down faster than the body can rebuild them, which can lead to the brittle, vulnerable bones of osteoporosis. The drugs work to slow down the bone-dissolving process, letting the cells that work to build bone mass catch up.

The drugs are incorporated into the newly formed bone and can stay there for years, even after a woman stops taking them.

It's not clear how many women are affected by the FDA's recommendations, but the researchers estimated that as many as 70 percent of women currently taking bisphosphonates could be candidates for stopping the drugs after five years. A number of women stop taking the drugs after only one or two years anyway, because of several inconvenient aspects of the prescriptions, such as needing to remain upright for several hours after taking the drug.

Doctors emphasize that the risk of atypical fractures associated with bisphosphonates is very low and appears to account for less than 1 percent of leg and hip fractures overall. Dr. Beatrice Edwards, an associate professor of orthopedic surgery at the Northwestern University Feinberg School of Medicine, said she thinks the drugs are generally safe for as long as five years, but still keeps a close eye on her patients who take them.

The FDA's report said additional research is needed before doctors can determine if interruption of treatments is helpful.

For now, the FDA and other experts say women should be mindful of how long they have been taking the drugs and talk to their doctors about whether continuing to use the drugs is best for them. The FDA already placed a statement on the drugs' labels saying patients should be reevaluated periodically.

For patients at low risk of osteoporosis, experts recommend regular exercise and diets rich in calcium and vitamin D for staving off the disease.

Copyright 2012 ABC News Radio


FDA Announces New Warning Labels for Cholesterol Drug

iStockphoto/Thinkstock(WASHINGTON) -- Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes.  Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year.  She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear.  Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.

Many experts said the added labels should not deter patients from statins.  Instead, they should report any side effects they experience to their physician.

Consumers will be able to see the label changes on their medications within the next 30 days, Egan said. 

video platformvideo managementvideo solutionsvideo player

Copyright 2012 ABC News radio


Watchdog Group to Ask FDA to Define 'Whole Grains' Label

Hemera/Thinkstock(WASHINGTON) -- The Center for Science in the Public Interest will petition the Food and Drug Administration on Wednesday to stop letting manufacturers label their foods “Whole Grain” when they really aren’t and to start putting the percentage of whole grain on the packaging.

The government has encouraged Americans to eat more whole grains because they help prevent heart disease, but the FDA has never established a legal definition of what constitutes a whole grain.

“Multigrain,” “Whole Grain,” and “Whole Wheat” -- It turns out none of these terms have legal meaning.  By law, only whole wheat bread must be made with 100 percent whole wheat, but any other wheat product can have as much or as little wheat as the manufacturer decides.

The same thing is true for whole grain. According to Michael Jacobson, executive director of Center for Science in the Public Interest, a nutrition watchdog group, there is twice as much white flour as whole wheat flour in Old London Melba Toast. The story is true for Eggo Nutrigrain Whole Wheat Waffles, too.  According to CSPI, the waffles contain more white flour than whole wheat.

Sometimes companies even add coloring to give their products that beige whole wheat look, if they don’t contain much whole wheat.  Lance Whole Grain Crackers are one example.

“They add caramel coloring,” Jacobson told ABC News.

Multigrain is another undefined term.

“The only thing it means is that it has more than one grain,” Jacobson said.  “It doesn’t mean that any of them are healthful.”  In other words, the multiple types of grain could all be refined flour, not whole grains.

So how can you choose wisely? Nutritionists say if the front of the package boasts “Whole Grain” make sure the first and most prevalent item in the ingredient list on the back really is whole grain.

video platformvideo managementvideo solutionsvideo player

Copyright 2012 ABC News Radio


All Imported Orange Juice to Be Tested for Fungicide, FDA Says

iStockphoto/Thinkstock(WASHINGTON) -- The Food and Drug Administration says it will be testing all orange juice entering the U.S., after low levels of the fungicide carbendazim were found in imported OJ.

“We have initiated testing of orange juice both at ports of entry and in the United States,” Michael Taylor, the FDA’s deputy commissioner for food told ABC News via email on Wednesday. “Very preliminary results show levels well below the level of any safety concern. … Our testing is just getting started.”

Carbendazim is used on fruit to kill fungi or fungal spores. It is not approved for use on oranges in the U.S., but it is used in Brazil.

The FDA was alerted to the presence of the fungicide by a company that found carbendazim in its own juice as well as the juice of competitors. The FDA has not identified the company or said where the juice originated.

According to the U.S. Department of Agriculture, 26.4 percent of orange juice consumed in the U.S. in 2010 was imported, and 56.4 percent of those imports came from Brazil.

However, the FDA spokeswoman said via email that the U.S., “does not receive fresh oranges from Brazil.”

Carbendazim has been found to cause birth defects in rodents. Studies also have shown that in human cells in laboratories, the chemical can cause chromosome problems. However, the chemical has not been shown to harm humans.

The FDA said on Wednesday that if the chemical is detected in any juice, it will not be allowed in the country. The U.S. agency said that the highest level of carbendazim found so far was still 1,000 times lower than the level of concern.

Although the FDA has started testing orange juice on store shelves, no products have been recalled.  In addition, the Environmental Protection Agency believes the fungicide levels in juice do not pose a public health threat and has not found any juice with levels higher than its level of concern.

No recalls are planned if the detected levels in juice found in stores are low.

Copyright 2012 ABC News Radio


Adderall Drug Shortage Will Continue in 2012, Gov't Officials Say

iStockphoto/Thinkstock(NEW YORK) -- A contentious relationship between drug manufacturers and the Drug Enforcement Agency may cause a continuing shortage of the attention deficit medication Adderall, which the Food and Drug Administration just added to its official drug shortages list, the New York Times reported.

As of 2007, about 9.5 percent of school-aged children, or 5.4 million, were diagnosed with Attention Deficit Hyper Disorder (ADHD), according to the Centers for Disease Control and Prevention. Since then, prescriptions for Adderall have numbered in the millions and continue to increase. And as demand for the drug grows, more and more patients have found the medication is out of stock at local pharmacies.

Experts say it’s difficult to say where the reason for drug shortage lies. To manage controlled substances that can potentially be abused, the DEA sets manufacturing quotas for drug ingredients each year to control supplies like Adderall. But Adderall drug manufacturers, which include Shire Plc and Novartis, Teva and CorePharma LLC, say they cannot meet the growing demand for the product without looser limits from the DEA.

The DEA questions whether there is actually a shortage of generic supplies, which are at an especially low supply, or whether the drug companies want to sell more of the expensive brand-name drugs.

Despite the growing demand, Special Agent Gary Boggs of the DEA’s office of diversion control told the New York Times, "We believe there is plenty of supply."

Copyright 2012 ABC News Radio


Unsanitary Conditions at Chicago Food Manufacturer Halts Production

GK Hart/Vikki Hart/Getty Images(CHICAGO) -- Chicago-based Triple A Services Inc. has agreed to stop making its ready-to-eat sandwiches and produce after unsanitary conditions were discovered at its facility, the U.S. Food and Drug Administration announced Thursday.

The FDA says its investigators have repeatedly found unsanitary conditions and bacterial contamination, and that the company has agreed to stop making and distributing its products as part of a consent decree filed in a Northern Illinois district court. The company is also required to hire a sanitation expert to establish an effective sanitation program.

There have not been any reports of illness as a result, the FDA said.

Click here for more from the U.S. Food and Drug Administration.

Copyright 2011 ABC News Radio

ABC News Radio