From The Washington Post:

Tackling a serious and long-standing public health problem, Deborah Autor of the Food and Drug Administration (FDA) leads an ongoing, multi-year initiative to remove hundreds of potentially dangerous prescription medicines from the market that were never approved for their safety or effectiveness as required by law.

As director of the FDA's drug compliance office, Autor designed the program to identify the unapproved drugs, evaluated the public health consequences, explored the legal challenges, set up incentive, education and outreach programs, and initiated an aggressive enforcement effort.

The FDA so far has taken enforcement actions to remove more than 500 unapproved prescription drugs from the market, impacting more than 275 drug manufacturers and distributors. Autor estimates that unapproved medicines represent less than two percent of prescriptions filled every year. But in the multibillion-dollar U.S. prescription drug market, this means that many thousands of consumers are exposed to drugs that may be unsafe.

The targeted medications have included cough medicines, antihistamines, certain single-ingredient narcotics, analgesics for pain, anti-inflammatory drugs, migraine medicines, gastrointestinal pharmaceuticals and many other products, including some prescribed to children and some reportedly linked to deaths.

Many of these unapproved medications were on the market before Congress made successive changes to the drug approval process, including 1962 amendments that required that pharmaceuticals not only be safe but also effective. While most pre-1962 prescription remedies were later evaluated by the FDA, many claimed exemptions because they or similar drugs were marketed without FDA approval before the changes to the law.

Autor's team found that most of the "grandfathered" drugs had been changed their formulations, dosages, how they are administered, and for what patients and conditions they are recommended making them "new" drugs requiring formal review and approval. Other unapproved drugs were not even grandfathered, yet manufacturers ignored the FDA approval requirement. The unapproved drugs have names and packaging that look just like approved drugs and they are even in the Physicians' Desk Reference.

For example, the FDA ordered a number of manufacturers to stop marketing unapproved drugs that contain quinine, which is often used to treat leg cramps. The agency said it has received 665 reports of serious adverse events associated with quinine use since 1969, including 93 deaths. Among the side effects of quinine are cardiac arrhythmias, thrombocytopenia and severe hypersensitivity reaction.

From Business Week:

The Wisconsin state Senate has passed a bill that would ban the chemical bisphenol A from baby bottles and other cups for children.

The Senate passed the bill unanimously Tuesday. A similar bill also passed unanimously out of an Assembly committee on Tuesday as well.

The Senate bill would ban BPA in cups and bottles intended for children under age 3.

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And from The News Tribune:

A bill to ban the use of an industrial chemical found in food and beverage containers used by children sailed through the House on Monday on a 95-1 vote.

If the legislation becomes law, Washington will join Minnesota and Connecticut as the only states to eliminate bisphenol A (BPA) in children’s products.

The vote came 10 days after the U.S. Food and Drug Administration voiced concerns about BPA’s potential effects on the brain, behavior and prostate gland of fetuses, infants and young children.

The BPA ban in children’s food and beverage containers, and water bottles was one of three priorities of the environmental community in the 2010 state Legislature.

The state legislation is necessary because the FDA didn’t endorse an outright ban on BPA in children’s products, supporters of the bill said.

From The New York Times:

European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.

On Thursday, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.

The F.D.A. said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Abbott, which sells Meridia in Europe under various brand names, including Reductil and Ectiva, indicated Friday that it would comply with the F.D.A.’s labeling request and with the European advisory by suspending sales of the drugs in Europe.

Meridia contains the ingredient sibutramine, which works by increasing neurotransmitter activity in the brain, helping people to feel full after a meal and thereby reducing their food intake. The company said the drug was safe and effective when used in appropriate patients.

The study, called the Scout trial, was the first test to see if a diet drug could reduce the risks of heart attacks.

Some experts said the finding that Meridia actually increased such risk in some high-risk patients rather than reduce it could raise questions about the safety of other diet drugs. The findings might also raise the safety hurdle for new obesity drugs to win approval. However, some experts said the problems might be unique to Meridia, which clearly raises blood pressure and heart rate.

In any case, the significantly different actions by the two health authorities is stirring debate among drug makers and consumer advocates. Did the European agency act too quickly on a set of preliminary data — or was it moving more forcefully to defend consumer health than its American counterpart?

Meanwhile, the F.D.A. said it planned to wait for the company’s complete report on the study, due in March, before considering further action on the drug.

From the U.S Food and Drug Administration:

The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.

The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug and to dispose of it immediately. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.

The counterfeit Alli looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• a missing LOT code on the outer cardboard packaging
• an expiration date that includes a MONTH, DAY, and YEAR—the expiration date of the real Alli only contains a MONTH and a YEAR
• a plain foil for the inner safety seal without any words on it—the safety seal of the real Alli has the words “SEALED FOR YOUR PROTECTION” prominently printed on it.
• large capsules with white powder, as opposed to small white pellets found in the real Alli
• a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli

Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; instead it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician.

From The New York Times:

In a shift of position, the Food and Drug Administration is expressing concerns about possible health risks from bisphenol-A, or BPA, a widely used component of plastic bottles and food packaging that it declared safe in 2008.

The agency said Friday that it had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans.

Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula, and that nearly everyone is exposed to it, starting in the womb.

But health officials said there was no proof that BPA was dangerous to humans.

Nonetheless, health officials suggested a number of things people could do to limit their exposure to BPA, like throwing away scratched or worn bottles or cups made with BPA (it can leak from the scratches), not putting very hot liquids into cups or bottles with BPA and checking the labels on containers to make sure they are microwave safe. The drug agency also recommended that mothers breastfeed their infants for at least 12 months; liquid formula contains traces of BPA.

The government will spend $30 million on BPA research in humans and animals, to take place over 18 to 24 months, health officials said at a news briefing on Friday.

Dr. Linda Birnbaum, director of the National Institute of Environmental Health Sciences, said the research would involve potential effects on behavior, obesity, diabetes, reproductive disorders, cancer, asthma, heart disease and effects that could be carried from one generation to the next.

From The Wall Street Journal:

U.S. government fines have made big drug makers "more sensitive than we've ever been" about preventing illegal promotion of their drugs, the chief executive of AstraZeneca PLC said in an interview.

AstraZeneca in September reached a preliminary agreement to pay $520 million to settle a U.S. investigation into its marketing of the schizophrenia drug Seroquel, including allegations that the company promoted the drug for uses for which it isn't approved by the Food and Drug Administration. This practice, called "off-label marketing," is illegal.

AstraZeneca officials have declined to say whether the company will admit wrongdoing as part of the settlement, the terms of which are still under discussion. In an interview in London, chief executive David Brennan said: "We don't promote products off-label."

But he said off-label marketing has become "a much bigger issue in the last few years as a result of the government's position on this."

A number of drug companies, including Pfizer Inc. and Eli Lilly & Co., have reached large settlements in recent months with U.S. investigators probing marketing practices.

Doctors are free to prescribe drugs any way they see fit, but drug makers aren't allowed to promote them for unapproved uses.

Controversy has long dogged Seroquel. AstraZeneca is facing thousands of lawsuits filed by patients who allege that Seroquel caused them to develop health problems including diabetes.

Earlier this year, lawyers representing those plaintiffs released documents that they said showed that AstraZeneca executives discussed promoting the drug for unapproved uses. The documents cited plans to "broaden Seroquel use on and off-label," including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups.

From the Associated Press:

Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient's kidneys and raise their risk of death?

Chances are you didn't, and neither did your doctor. Much of what the Food and Drug Administration knows about a drug's safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible.

In this week's issue of the New England Journal of Medicine, researchers from Dartmouth College argue that drug labels don't reflect the nuanced decisions the FDA makes when deciding to approve a drug. The editorial from Drs. Lisa Schwartz and Steven Woloshin recommends easy-to-read fact boxes to help patients weigh the benefits and risks of medications.

If drug labels sometimes exaggerate benefits and play down drug risks, the authors say there's a very good reason: they are written by drugmakers.

While FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists.

The labeling is based on results from company studies, which generally compare results for patients taking the drug versus those taking placebo.

If FDA decides the drug's ability to treat or prevent a disease outweighs its side effects, the agency is obligated to approve it. But Schwartz and Woloshin point out that benefits may be slim and potential harms may not be fully understood.

In the case of Sepracor Inc.'s blockbuster sleeping pill Lunesta, it's virtually impossible to tell how well the drug works based on the labeling, which only indicates that it worked better than placebo, or a dummy pill.

Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.

"Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness," the authors state.

Despite that lackluster finding, the drug has grown into a $600 million-a-year drug for Sepracor, helped by the company's advertisements featuring a green Lunesta moth.

FDA review documents can also hide critical safety information.

The authors point to the example of Novartis' Zometa, which was approved in 2001 to prevent skeletal fractures in cancer patients with brittle bones. The drug was approved in both 4-mg and 8-mg doses, despite FDA findings of increased kidney damage and death with the higher dose.

FDA went back and added language about kidney toxicity in 2008, but the information about death rates is still missing from the label.

While FDA reviews are posted online, they are often hundreds of pages long and written in extremely dense medical language.

From Forbes:

The Food and Drug Administration said Tuesday makers of the antihistamine and anti-nausea drug promethazine have to warn consumers over the potential risk of tissue injuries including gangrene if the injectable drug is administered incorrectly.

The FDA is requiring companies to include a warning on the drug's label to state that it should not be administered into an artery or under the skin because of the risk. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue, the agency said.

The drug should be injected deep into a muscle.

Also, a requested revision to the label proposes that if health care professionals choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration.

Companies making the drug are required to submit safety label changes to the FDA within 30 days or provide a reason why they feel changes are not necessary.

Promethazine was previously sold under the brand name Phenergan by Wyeth ( WYE - news - people ), but the company discontinued the formulation. Several generic drug developers now make formulations of the injectable drug. The drug first hit the market in 1956 and prior warnings over potential tissue injuries have been stated, but have not been required to be included in a box warning.

From WJLA News:

Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.
A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.

After two tours of duty in Vietnam, O'Donnald Parker depends on acetaminophen -- through Percocet and Tylenol -- to manage his pain.

In the mid-1990s he was diagnosed with severe liver damage. Parker's doctor said the medication may partly be to blame.

"I have to take it in moderation," he said. "I have to be real careful with it. I only take it when I absolutely need it."

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson's Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

The drugs in question, such as Procter & Gamble's NyQuil or Novartis' Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.

The panel voted 24-13 to keep the products on the market.

From The New York Times:

Federal regulators warned consumers on Tuesday not to use body-building products that are sold as nutritional supplements but may contain steroids or steroidlike substances, citing reports of acute liver injury and kidney failure.

The Food and Drug Administration said it issued the warning because of increased reports of medical problems in men who had used such products.

But except for naming eight specific supplements sold by a single company, the Food and Drug Administration did not provide much clear guidance to consumers on what other products to avoid. The F.D.A. acknowledged that it did not know how many products its warning affects.

Generally, the F.D.A. said, buyers should beware of body-building products that claim to enhance or diminish the effects of hormones like testosterone, estrogen or progestin. In particular, the agency said consumers should not buy products labeled with code words like “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno.” The references to estrogen and “gyno” are meant to indicate the products do not have a feminizing effect on the body, like swelling breasts or shrinking testicles, which can be unwanted side effects of steroid use in men.

The F.D.A. cited eight popular products from American Cellular Labs, including Mass Xtreme and Tren Xtreme, that the agency found to contain hidden and potentially hazardous steroids. The agency sent a letter on Monday warning the company to make the products comply with federal regulations. Last week, federal agents in San Francisco executed search warrants for the company and for a San Francisco outlet of Max Muscle, a chain of sports nutrition stores, some of which sold the products cited by the F.D.A.

“We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same,” Michael Levy, director of the Division of New Drugs and Labeling at the agency’s Center for Drug Evaluation and Research, said in a conference call with reporters on Tuesday. The agency, he said, is considering taking action against those firms as well.

The warning is part of a larger investigation into body-building products that contain hidden steroids, according to court documents in the American Cellular Labs case. A spokesman for Joseph P. Russoniello, the United States attorney for the Northern District of California, said he could not comment on open investigations.

But Travis Tygart, the chief of the United States Anti-Doping Agency, which oversees the drug testing of Olympic athletes, estimated that there could be 50 or more other brands on the market that contain the same steroids as those in the American Cellular products. The F.D.A. warning follows the agency’s crackdown on more than 70 brands of weight-loss supplements that the agency found to illegally contain hidden and potentially dangerous active pharmaceutical ingredients.

But the federal regulations governing dietary supplements are inadequate to protect consumer health, according to some experts who have studied the safety of such products.

Unlike drug makers, which must demonstrate that a drug is safe and effective before the agency approves it for sale to the public, dietary supplements are a largely self-regulating industry. Manufacturers of such products are themselves responsible for the safety and effectiveness and marketing claims of their products, and for voluntarily recalling them if problems arise. The F.D.A. has authority to act only after it has received reports of serious health problems associated with products already on sale and it is able to prove a serious health hazard. If a company refuses to voluntarily recall problem products, the agency can then file an injunction and seize the products.

Such a reactive strategy puts consumers at risk, critics said.