News / Health & Wellness
Warning for Diabetic Drugs sought by FDA
The U.S. Food and Drug Administration has requested a "black box" warning on two type 2 diabetes drugs. They want to warn patients that taking the medication might raise their risk of congestive heart failure.
The two drugs Avandia, made by GlaxoSmithKline, and Actos, made by Takeda Pharmaceuticals, need a "more prominent" warning because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."
FDA Commissioner Dr. Andrew von Eschenbach gave a testimony before a Congressional committee requesting the strictest warning issued to both companies producing the drugs. The warning was issued to both companies on May 23.
A study in the New England Journal of Medicine found Avandia controversial. The study revealed the drug could increase a patient’s risk of a heart attack by 43 percent. After the report on Avandia was released the FDA issued a safety alert but said more studying was needed before they would issue a stronger warning label.
"The Food and Drug Administration is aware of a potential safety issue related to rosiglitazone," said the director of the FDA’s Office of Drug Evaluation ll, Dr. Robert J. Meyer. , "At this point, we have not reached a definitive conclusion on the data. We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."
A study funded by GlaxoSmithKline showed Avandia did not increase the risk of a heart attack or death from heart disease.
"Overall, there was no significant difference between those on rosiglitazone and those not on rosiglitazone," said Stuart J. Pocock of the London School of Hygiene & Tropical Medicine. "The concern about cardiovascular death, I think, we have clearly deflated. The concern on heart attack -- our data are modifying that concern, but it's still inconclusive."
Takeda Pharmaceuticals announced Wednesday they would be putting the black box warning on their prescription labels for Actos. "Takeda remains confident in the safety and efficacy of Actos when used according to its label, and with this revision, we can heighten patient and physician awareness of an already known, but serious side effect," Dr. Robert Sphanheimer of Takeda said.
GlaxoSmithKline say they are confident the British study should reveal to type 2 diabetes patients that Avandia is safe to use.
"They [the findings] add to the weight of evidence, from both previously published long-term clinical trials and other studies, that the overall ischemic cardiovascular safety profile of Avandia is comparable to the traditional anti-diabetes treatments. Patients and physicians should find these data reassuring," said GlaxoSmithKline company chairman Moncef Slaoui.
The American Diabetes Association issued a statement saying "As a result of all of this information, the American Diabetes Association strongly encourages patients taking this medication to consult with their physician as to its benefits and risks," the statement read. "The Association also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health-care provider."
