Actos and Avandia Black Box Warning for risk of heart failure

By Harvey Kirk
Posted August 15, 2007

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The FDA announced late yesterday that the manufacturers of Avandia and Actos have agreed to add a stronger black box warning regarding the increased risk of heart failure.  The announcement comes two months after federal regulators testified at a congressional hearing that they would be requesting the drug makers add such a warning. 

This black box warning does not address the concerns regarding the increased risk of heart attacks which has been associated with Avandia.  The heart attack risk was reviewed last month by an FDA advisory panel.  The FDA indicates that they are still evaluating the panel’s recommendation that a specific warning should be added to Avandia about the increased risk of heart attacks.

>>INFORMATION: Avandia Heart Attack Risk

BLACK BOX HEART FAILURE WARNING

The new black box warning which will be added to the type 2 diabetes drugs is the strongest warning which can be affixed to a prescription medication.  The entire class of anti-diabetic drugs, known as thiazolidinediones (TZDs), will indicate that they may cause or worsen heart failure.  The class includes Avandia (rosiglitazone), Actos (pioglitazone), and all combo-drugs containing these medications, such as Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepride).

Heart failure is a serious condition which occurs when the heart does not adequately pump blood.  The warning will indicate that the drugs should not be used by those with serious or severe heart failure and that doctors should carefully monitor their patients for signs of problems.  Symptoms of heart failure could include rapid weight gain, shortness of breath or edema.

AVANDIA HEART ATTACK RISK

Following a report released by the New England Journal of Medicine in May, a lot of concern and debate has surrounded the Avandia heart attack risk.  An independent review of data from clinical trials found that Avandia increases the risk of heart attacks and heart related death. 

A heart attack is different from heart failure.  Heart attacks are a much more serious concern, which occurs when the blood flow to the heart is cut off.  This could result in severe injuries or even death.

An increased risk of heart attacks is especially troubling for type 2 diabetics.  A new study published today in the Journal of the American Medical Association (JAMA), found that a heart attack is much deadlier for those with diabetes than for those who do not have the disease.  Researchers found that after a year, people with diabetes who have a mild heart attack face the same risk encountered by a person without diabetes who suffers a severe heart attack.

Last month, an FDA advisory panel reviewed the heart problems linked to Avandia.  Although the panel voted against an Avandia recall, they clearly indicated that Avandia side effects increase the risk of a heart attack.  Some panel members recommended that an Avandia black box warning should be added about the increased risk of heart attacks as well.  The FDA is expected to take action on the recommendation in the coming weeks.  While the FDA is not required to follow the recommendations of their advisory panels, they usually do.

AVANDIA LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential Avandia lawsuits for users of the diabetes drug who suffered a heart attack, stroke, heart failure or death.  It has been estimated that as many as 200,000 heart attacks and deaths have been caused by Avandia since it was approved by the FDA.  Many of these injuries could have been prevented if the drug manufacturer had provided earlier warnings.

If you, a friend or family member believe you may have a case, request a free Avandia claim evaluation.