U.S. OKs heart failure warning on diabetes drugs
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Diabetes drugs made by GlaxoSmithKline Plc and Takeda Pharmaceutical Co Ltd will carry new, stronger warnings saying they may or cause or worsen heart failure, U.S. health officials said on Tuesday.
The warnings will appear in a “black box” on Glaxo’s Avandia, Avandaryl and Avandamet, as well as on Takeda’s Actos and Duetact, the Food and Drug Administration said in a statement. A black box is the strongest type of warning in the United States for prescription drugs.
Congestive heart failure is a chronic condition in which the heart does not adequately pump blood through the body. Symptoms may include shortness of breath and excessive, rapid weight gain.
Heart failure is different from a heart attack, which cuts off blood flow and damages the muscle. Heart failure occurs when the heart muscle weakens and can no longer efficiently pump enough blood into the circulatory system. A review of Avandia and a possible increased risk of heart attacks is ongoing, the FDA said.
The warning finalized on Tuesday says patients with heart failure in either of the two most severe classes should not start taking the drugs, and they are not recommended for patients with heart failure that causes symptoms.
If patients develop heart failure after they start taking the medicines, doctors should try to manage the symptoms and use of the drugs “should be reconsidered,” the FDA said.
The drugs had come with less prominent warnings about heart failure, but FDA officials were concerned that doctors were still prescribing the medicines to patients with the condition.
The agency said it had received reports of patients with heart failure symptoms who were continued on the drugs and died.
“This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed on the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure,” Dr. Steven Galson, director of the agency’s Center for Drug Evaluation and Research, said in a statement.
The FDA disclosed in June that it had asked Glaxo and Takeda to add a stronger heart failure warning to the medicines.
Chris Viehbacher, Glaxo’s president of U.S. pharmaceuticals, said doctors have known about the heart failure issue.
“I don’t, at this stage, think we’re going to see a significant impact on prescribing in terms of dollar value,” Viehbacher told reporters on a conference call.
A Takeda spokesman could not immediately be reached for comment.
Sales of Avandia, which were $3 billion last year, have been hurt recently by questions about whether the drug raises the chances of having a heart attack. An advisory panel concluded in July that Avandia did carry that risk and urged a new warning on the drug.
Avandia is known generically as rosiglitazone. Avandamet combines rosiglitazone with the drug metformin, while Avandryl pairs rosiglitazone with glimepiride.
The generic name for Actos is pioglitazone. Duetact is a combination of pioglitazone and glimepiride.
Avandia and Actos are so-called thiazolidinediones that were designed to make the body more sensitive to insulin, a hormone the body needs to convert sugar into energy.
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