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News Articles >> FDA Internal Memo: Early "Black Box" Rec..
FDA Internal Memo: Early "Black Box" Recommendation Ignored
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| July 14, 2007. By Anne Borden |
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Washington, DC: A 2006 internal FDA memorandum suggests that the FDA recommended GlaxoSmithKline, the maker of Avandia, add a "black box" (the strongest warning) about congestive heart failure to the drug's label more than a year ago. As well, a warning about macular edema, which can lead to blindness, was also recommended.
Even though the recommendations were approved by the Deputy Director of the FDA's Division of Drug Risk Evaluation, they were not added to Avandia's label. In fact, the Deputy Director who made the recommendations, Dr. Johann-Lang, was demoted shortly thereafter.
Former Director Speaks Out
Congestive heart failure (CHF) "is a very, very clear adverse reaction syndrome" with Avandia, Dr Johann-Lang told USA Today recently.
Dr. Johann-Lang has since left the FDA, stating that she would like to have continued working with the FDA, "if the agency had a vision of promoting and protecting public health."
In response to the Avandia scandal, the Senate Finance Committee sent a letter to the FDA questioning its practices and suggesting that retaliatory action may have been taken against FDA whistleblowers.
According to a recent Bloomberg News investigation, the FDA may have known about risks associated with Avandia as far back as April 1999. Some health advocates suggest that Big Pharma has too much influence in FDA decision-making, and that dangerous drugs are too readily approved by the agency.
Going to Court and to Congress
Not surprisingly, lawsuits against Avandia are on the rise.
Some lawsuits are being pursued by family members of people who have died from CHF and other complications. For example, Peggie Stanford has filed suit against GlaxoSmithKline claiming that Avandia use led to her husband's death. Larry Alan Stanford, 60, of Beaumont, Texas, suffered a heart attack and died May 21. Mr. Stanford had been taking Avandamet, a form of Avandia, since early 2005.
But it's not just families who are taking their case to the courts. GlaxoSmithKline has also been hit with a lawsuit from its shareholders, who claim that the drug maker withheld information from the investing public as to the safety of Avandia.
Congress has also taken notice of the issues. A congressional hearing was held about the FDA and Avandia on June 6, where FDA representatives gave testimony, as did employees of GlaxoSmithKline. That same day, the FDA requested that GlaxoSmithKline put new information, in the form of a Black Box warning on Avandia. This time, the company complied.
In the face of lawsuits and an upcoming FDA advisory panel on Avandia's safety, GlaxoSmithKline is "going into full damage-control mode," in the words of an industry watchdog.
New Health Concerns
Adding grease to the fire, Reuters has reported that a new study suggests Avandia could lead to bone fractures in men as well as women. The study, published in Diabetes Care, provides evidence that men might be exposed to similar risks as those previously reported in women - that is, a significant reduction in bone mineral density seen in those taking Avandia.
Analysts at Morgan Stanley say that this new data further increases the likelihood that Avandia's label will be toughened to include stronger warnings about bone safety.
Physicians are increasingly reluctant to prescribe the drug, and many patients are also concerned. If you have taken Avandia, it is recommended that you speak to your doctor. If you believe that you or a loved one may have suffered as a result of Avandia, legal counsel is recommended.
Coming soon: more information about Avandia risks from a recent report in The New England Journal of Medicine.
Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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