DRUG ALERTS AND “BLACK BOX” WARNINGS
After a prescription drug is approved for sale in the U.S. by the U.S. Food and Drug Administration (“F.D.A.”), if reports of problems begin to surface, the F.D.A. will take one of various types of actions to address the issue. Depending on the problem—whether the drug is linked to adverse consumer reactions, injuries, deaths, or if the drug is found to be improperly advertised, labeled or manufactured—the F.D.A. can take the appropriate action. The F.D.A. issues various types of alerts, warnings, and restrictions to consumers, healthcare professionals, drug manufacturers, drug company sales representatives and others in the industry. These warnings include public health and safety alerts, dear doctor letters, sales/labeling restrictions, and the most serious: the “black box” warning. The F.D.A. issues its black box warning, placing it right on the drug’s label, to warn the drug’s users of potentially serious threat of dangerous or deadly side effects.
All prescription drugs have side effects. The true side effects of a new prescription drug about to be released on the market are never known in their entirety; pre-marketing clinical studies are, of necessity, limited in scope. It’s only after the drug’s launch and its widespread consumption by the public, that a true understanding of its adverse side effects is discovered. If reports begin to surface of a drug’s adverse side effects, either through new clinical studies or through an unusually high number of adverse patient reports, the F.D.A. can either issue its black box warning, or, it can try to force the manufacturer to voluntarily recall the drug.
Over the last five years, the F.D.A. has issued a high number of black box warnings for drugs found to pose a serious risk to the public. For example, in 2007 the F.D.A. issued a black box warning for the diabetes drug rosiglitazone, marketed under the brand names Avandia, Actos, Avandamet, Avandaryl, as their use was linked to danger of congestive heart failure. The black box warning was revised twice in the six months after the original warning, due to several reports, including a study in New England Journal of Medicine linking rosiglitazone to fatal cardiovascular events. Avandia and the related drugs are still on the market, with the black box warnings in place, but have not been recalled.
Yaz (Yasmine/Ocella) a popular birth control drug, approved by the F.D.A. in 2006, had a black box warning issued for it in August 2009, due to its use being linked to serious cardiovascular side effects, such as blood clots, heart attacks, and strokes, for those who use smoke while using the drug. It is still on the market and among the top three highest selling birth control pills in the U.S.
Darvon/Darvocet (Propoxyphene) is a widely used pain reliever, on the market in the U.S. for over 50 years. In 2009, pills with its active ingredient Propoxyphene were prescribed to over 9 million Americans. The F.D.A. issued a black box warning on it in July 2009, allowing it to stay on the market so long as it contained the warning that its use was linked to fatal overdose. Only in November 2010, did the F.D.A. order a recall, finding that its use altered the electrical activity of the heart.
Plavix, a hugely popular anti-clotting medication, received a black box warning in March 2010, due to reports of its ineffectiveness, due to metabolism problems, with certain patients who were using it to reduce risk of heart attack and stroke.
- Drug-Recalls.Org. Disclaimers and Notices: Not all drugs mentioned herein have been recalled. The F.D.A.’s black box warnings are found on a lot of drugs that have been approved, are still on the market, and that may be helping millions of people a year with their medical conditions. It only means that the user must be aware of the potential problems and risks associated with the drug’s use.
- FDA warns that you should not stop taking any prescribed medication without first consulting with to your doctor.
- Reports of serious drug side effects should be made to the US FDA MedWatch program.
- The prescription drug names contained herein are registered trademarks of the respective drug companies.
- Drug-Recalls.org is not affiliated with any of the drug companies, nor the F.D.A.