Entries in FDA (230)


FDA Issues Warning About Potentially Dangerous Vitamin Supplement

Jupiterimages/Thinkstock(NEW YORK) -- The Food and Drug Administration has issued a warning about a vitamin supplement which reportedly contains two possible dangerous anabolic steroids.

The FDA wants consumers to avoid a Vitamin B dietary supplement from Healthy Life Chemistry by Purity First. The agency says the company's B-50 supplements tested positive for two steroids used by some bodybuilders illegally. Neither ingredient is on the product label.

According to the FDA, Healthy Life Chemistry has declined a government request for a voluntary recall of the product.

Copyright 2013 ABC News Radio


Blood Drive Protests FDA Ban on Gay Donors

Gillian Mohney/ABC News(NEW YORK) -- After Marshall Duer-Balkind, 30, exited a blood donation center on Friday morning, he held up a long green form as evidence that he had been rejected as a blood donor.

On the form Duer-Balkind pointed out that section that disqualified him from being a blood donor because of a U.S. Food and Drug Administration policy that bans men who have sex with men from giving blood.

After Duer-Balkind showed the form to two volunteers from the National Gay Blood Drive demonstration, the volunteers pulled out a red ink pad and stamped "Rejected" on his forearm.

The stamp was proof that Duer-Balkind had taken part in a nationwide demonstration to protest the FDA policy, which pervents men who engage in homosexual sex from donating blood, since they are considered at a higher risk for having HIV.

"I think it's an absolutely ridiculous and antiquated policy," said Duer-Balkind, who had come to participate in the demonstration during a vacation in New York.

There were more than 50 demonstrations planned as part of the National Gay Blood Drive in various U.S. cities on Friday. The drive was planned to help draw attention to the number of potential blood donors who are automatically disqualified due to their sexual orientation. In addition to men who have sex with men, women are disqualified from giving blood if within the last 12 months they have had sex with a man who at any point since 1977 has had sex with another man.

At designated blood donation centers across the country, participants in the National Gay Blood Drive were tested for HIV and if they tested negative, attempted to donate blood at a blood donation center. When they were rejected due to FDA regulations, they received a stamp and turned in their HIV testing results to be sent to the FDA.

The FDA's decades-long ban stared during the AIDS crisis and restricts any man, who has had sex with another man since 1977, from donating blood.

In recent years as HIV testing has improved, the policy has come under fire for being discriminatory and outdated. In June the American Medical Association voted to oppose the ban.

The National Gay Blood Drive was organized by independent filmmaker Ryan James Yezak, 26, who was inspired to act after he was forced to explain to co-workers he could not donate blood because he was gay.

"There's a really alienating feeling," said Yezak, who is working on a documentary about discrimination based on sexual orientation. "That's the first time I felt direct anti-gay discrimination and once you feel that you can't ignore it."

Yezak said that 1,400 people have said they would attend different demonstrations. At one New York City location, there had been over 20 participants by noon.

The demonstration comes just days after the American Red Cross issued an emergency request for blood and platelet donations since June donations were down 10 percent.

Yezak said the he hopes the FDA will craft a new blood donor policy that is based on behavior associated with high HIV risk rather than just sexual orientation. He also said one step could be adopting a policy similar to other countries, such as Canada or the United Kingdom, where men who have sex with men can donate blood if they abstain from sex for a certain period of time.

In 2010 an FDA Advisory Committee on Blood Safety found that the current ban on gay men as blood donors was "suboptimal" but voted to keep the policy pending further research. The U.S. Health and Human Services is performing additional studies to see what policy revisions should be undertaken.

According to the FDA, men who have sex with men made up 61 percent of all new HIV infections in the U.S. in 2010. Although HIV testing is performed on all donated blood, there are rare cases where HIV is not detected because the infection is too new. According to the FDA there is an HIV risk in 1 out of every 2 million units of donated blood.

In response to a request for comment from the FDA regarding the National Gay Blood Drive, an FDA spokesperson wrote that the "FDA's primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products … We applaud the critical contributions made by blood donors and we are sensitive to the concerns of potential donors and other individuals affected by current blood safety policies."

Copyright 2013 ABC News Radio


FDA Rule Could Make Generic Drugmakers More Liable to Lawsuits

iStockphoto/Thinkstock(NEW YORK) -- A new rule could open the door for lawsuits against generic drugmakers, which are currently protected by a legal obligation to copy the formulas and labels of their name-brand counterparts.

The rule, proposed Wednesday by the U.S. Food and Drug Administration, would allow generic drugmakers to change their labels to reflect "newly acquired information," such as safety risks.

The proposal comes a week after the Supreme Court stripped Karen Bartlett of $21 million in damages awarded to her by a jury after she was burned and blinded by the generic painkiller Sulindac.

"I was numb," Bartlett said of the moment her lawyer delivered the news. "I don't even have words to describe it because I can't believe that they would do that."

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004 "wrapped up like a mummy" as the skin eroded over two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including nonsteroidal anti-inflammatory drugs such as Clinoril and Sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing, she said.

"I have no independence," said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. "This ruined my life, basically."'

At the time of Bartlett's reaction, Sulindac's label did not specifically warn about Stevens-Johnson syndrome, the Supreme Court acknowledged, although it did warn that the drug could cause "severe skin reactions" and "fatalities." But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

"Here, it is impossible for Mutual [the maker of Sulindac] to comply with both its federal-law duty not to alter Sulindac's label or composition and its state-law duty to either strengthen the warnings on Sulindac's label or change Sulindac's design," Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

Under the new rule, generic drugmakers could strengthen the language of their warning labels independently.

Consumer watchdog group Public Citizen applauded the FDA, having petitioned for a similar rule in 2011.

"Many potential hazards are not discovered until years after drugs have been on the market," Public Citizen's Health Research Group founder Dr. Sidney Wolfe said in a statement. "Yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk."

"The proposed rule is a classic example of harm reduction," Wolfe added. "When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

Copyright 2013 ABC News Radio


FDA Approves New Drug for Hot Flashes

iStockphoto(NEW YORK) -- The Food and Drug Administration approved a new and somewhat controversial drug to treat moderate to severe hot flashes and night sweats associated with menopause on Friday.

There are several drugs that treat hot flashes, which up to 75 percent of women experience, but Brisdelle is the first one that is non-hormonal. It contains a low dose of paroxetine, which is used in higher doses in the antidepressant drug Paxil.

Many are surprised that the FDA approved the drug after an expert advisory panel voted ten to four against it, saying it risks outweighed its benefits. But the FDA says many women are now opposed to hormonal treatments since being linked to increased risk of breast cancer.

“There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” said Hylton V. Joffe, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “[Friday’s] approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.”

According to the FDA, the most common side effects of Brisdelle are headache, fatigue, and nausea and vomiting.

Copyright 2013 ABC News Radio


FDA Investigating Hepatitis A Outbreak in Five States

iStockphoto/Thinkstock(NEW YORK) -- The U.S Food and Drug Administration and the Centers for Disease Control and Prevention are investigating an outbreak of Hepatitis A in five states that may be linked to a frozen food blend.

According to a press release from the FDA, at least 30 people have been infected with Hepatitis A in Colorado, New Mexico, Nevada, Arizona and California. Thus far, 11 of 17 patients interviewed by the CDC said they ate Townsend Farms Organic Anti-Oxidant Blend before they got sick.

The FDA has already begun to inspect Townsend Farms' processing facilities in Fairview, Ore. Additionally, the FDA is working on a method to test berries for the Hepatitis A virus and will be testing samples related to the outbreak, including the frozen blend.

Hepatitis is a contagious liver disease that can range from mild to severe. According to the FDA, the infection is most commonly spread through ingestion of fecal matter, even in microscopic amounts. Symptoms of Hepatitis A include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool.

The CDC is recommending that consumer do not eat Townsend Farms Organic Anti-Oxidant Blend and that any remaining product should be thrown away, even if the product has already been partially eaten and no one has gotten sick. Retailers and food service operators are also being advised not to sell the anti-oxidant blend pending the end of the investigation.

Copyright 2013 ABC News Radio


Seven People Suffer Complications After Using Common Pain-Reliever

iStockphoto/Thinkstock(NEWBERN, Tenn.) -- Seven people in Midwest and south are suffering complications after being injected with medicine routinely used to treat back pain and joint swelling, and health officials are on the case because this particular medication already has a controversial history.

The Food and Drug Administration is focusing their investigation on the Main Street Family Pharmacy, a small pharmacy in Newbern, Tenn.

Health officials say seven people developed skin abscesses after being treated with an injectable steroid made at the pharmacy that is possibly contaminated.

While there is no conclusive evidence that the drugs are contaminated, health officials recommend that doctors immediately stop using any drugs sold by the pharmacy, and are conducting a thorough investigation. It's too soon to tell how many people were injected with the drug. It's already been shipped to 13 states, including California and both Carolinas.

“They shouldn't be in business if they’re doin’ that,” said Bob Newhouse, a Newbern resident. “When you talking about somebody's health, that's serious.”

The steroid in question, methylprednisolone acetate, is the same drug at the center of last year's deadly outbreak of functional meningitis which killed 55 people and sickened more than 700. Those cases were traced back to a single pharmacy in Massachusetts.

Copyright 2013 ABC News Radio


FDA Approves Over-the-Counter Plan B for Woman 15 and Older

Scott Olson/Getty Images(WASHINGTON) -- The Food and Drug Administration has approved Plan B One-Step, a brand of emergency contraceptive, to be available for women 15 and older without a prescription.

This comes almost a month after a federal judge ordered the FDA to make Plan B available to everyone over-the-counter, which will go into effect on May 5, unless the FDA appeals the ruling.

"The Department of Justice is considering next steps in the litigation," the FDA said in a statement. "In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older."

Judge Edward Korman ordered emergency contraceptive to be made available over the counter on April 5, citing "bad faith" that resulted in restricted access to the drug in the past. Prior to that, it was available to everyone 17 and older without a prescription.

When Korman, who presides over the District Court of Eastern New York, wrote his ruling, Teva Pharmaceutical Industries, which makes Plan B One-Step, had an application pending with the FDA to get the prescription-free age lowered from 17 to 15, according to the FDA statement.

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," said President of Planned Parenthood Federation of America's President Cecile Richards.

The morning-after pill is intended to be used when other contraception fails, such as when a condom breaks. Containing the synthetic hormone levonorgestrel, the pill works by preventing a fertilized egg from attaching itself to the uterine wall. But it must be taken within 72 hours of unprotected sex. It cannot terminate an existing pregnancy.

Although Wednesday's FDA approval means women seeking Plan B will need to have identification to prove they are of age to purchase it, the drug will no longer be available only when the pharmacy is open, according to an FDA statement. Instead, it will be available in the family planning and female health aisles.

In December 2011, Health and Human Services Secretary Kathleen Sebelius sparked controversy when she overruled the FDA after it recommended that emergency contraception be sold over the counter. The FDA spent 10 months reviewing scientific data before making its decision, but Sebelius said there wasn't enough data to declare the product safe.

"Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable," Korman wrote in his ruling.

Although the FDA has not yet made an announcement regarding Korman's order, some women's health organizations are concerned.

"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release.

She said requiring proof of age is a "significant barrier that all too many women of all ages will still find" even with the prescription-free age lowered to 15.

"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances," she said. "And we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."

Copyright 2013 ABC News Radio


FDA Investigating Connection Between Energy Drinks and Heart Risks

David Paul Morris/Bloomberg via Getty Images(NEW YORK) -- The Food and Drug Administration is investigating possible links between energy drinks and sudden death.

According to a study presented to the American Heart Association, there is a connection. Energy drinks, which can have up to three times the amount of caffeine as colas, were found to raise blood pressure and change heart rhythm in a way that was associated with life-threatening arrythmias.

The study found that energy drinks could increase the risk of sudden cardiac death.

Young adults consume as many as half of the energy drinks in the United States.

The FDA regulates the amount of caffeine in soft drinks because they are classified as food. Because energy drinks are considered dietary supplements, caffeine levels are not regulated.

Copyright 2013 ABC News Radio


FDA Approves First Artificial Retina for Rare Eye Disease

Comstock/Thinkstock(NEW YORK) -- The Food and Drug Administration approved the first retinal implant on Thursday, an advancement that could restore some vision to adults with a particular genetic disorder.

The Argus II system approved by the FDA on Thursday is the first implanted device approved for treatment of advanced retinitis pigmentosa, a rare genetic eye condition that affects the light-sensitive cells that line the retina. The system is intended for use in adults over the age of 25 and may help patients with day-to-day activities such as recognizing letters and words, detecting street curbs and matching pairs of socks.

After an artificial retina is implanted, patients are equipped with a pair of eyeglasses containing a small video camera and a video processing unit. The images from the video camera are converted into electrical impulses which stimulate the implanted retina to produce images, according to an FDA press release.

According to the Washington Post, the artificial retina was approved by European regulators in 2011 and costs approximately $100,000 there. In Europe, the implant is covered by insurance plans.

The Post reports that the surgery to implant the device takes approximately two hours and will be available at about 10 U.S. clinical centers initially. Additional clinical centers are expected to offer the treatment in the future.

The system was approved by the FDA as a "humanitarian use" device, which is limited to products that treat fewer than 4,000 people in the country per year. The FDA reviewed data collected from a clinical trial that included 30 participants and lasted at least two years in order to ensure that patients did not suffer any adverse effects.

While the current technology does not allow patients to see in color, the expectation is that future versions of the implant will provide high-resolution and color images.

Copyright 2013 ABC News Radio


FDA to Consider Tighter Rules for Prescription Painkillers

iStockphoto/Thinkstock(NEW YORK) -- The Food and Drug Administration is considering tighter controls on prescription painkillers like Vicodin -- a response to a spike in addiction rates and overdose deaths.

High profile battles with Vicodin have been well documented; even Eminem once rapped about his addiction.  Now, the U.S. Drug Enforcement Administration wants tighter controls on Vicodin and other narcotic painkillers containing the drug hydrocodone.  

The DEA argues patients shouldn't be able to get as many prescriptions at once, and pharmacies should have to keep the drugs locked in secure cabinets -- the same way they treat narcotics like OxyContin and Percocet.  

The FDA will consider the request during two days of hearings, beginning Thursday.

Copyright 2013 ABC News Radio

ABC News Radio