Side effects of Avandia outlined in new Medication Guide
This week, the FDA and GlaxoSmithKline released a new Medication Guide for Avandia (rosiglitazone maleate), which will be provided with each prescription dispensed. The Guide includes detailed information about the side effects of Avandia, including a potential increased risk of heart attacks, congestive heart failure and death.
>>MEDICATION GUIDE: Avandia Side Effects
The Medication Guide is designed to provide specific information about the side effects of Avandia. Under the authority of FDA regulation 21 CFR 208, the regulatory agency is requiring that the Medication Guides be provided every time a prescription for Avandia is filled. Such Guides are only required for certain medications that the FDA determines pose a serious and significant public health concern.
Concerns about the side effects of Avandia gained national attention in May 2007 when a study was published in the New England Journal of Medicine which found that users of the diabetes drug face a 43% increase in the risk of heart attacks. At that time, the manufacturers did not provide adequate warnings about these heart side effects and some experts have estimated that over 100,000 heart attacks could have been suffered since the drug was introduced in 1999.
>>INFORMATION: Timeline of Avandia Heart Problems
The new Medication Guide now indicates that the side effects of Avandia may increase the risk of heart failure, heart attacks and heart-related chest pain caused by reduced blood flow to the heart. Avandia can result in fluid retention, which can cause new or worsening of heart failure.
Individuals who have severe heart failure have been advised that they cannot start the Avandia diabetes medication and even if symptoms of heart failure (such as shortness or breath or swelling) are not severe, the risks could still apply. The Guide also indicates that most people who take insulin or nitrate medications should not also use the drug, since the risk of these Avandia heart side effects may be higher among those users.
AVANDIA SIDE EFFECT LAWSUITS
The Avandia lawyers at Saiontz & Kirk, P.A. represent users throughout the United States who have suffered a heart attack, stroke, congestive heart failure or death which may have been caused by side effects of Avandia. To determine if you, a friend or family member may be eligible for an Avandia lawsuit, request a free consultation and claim evaluation.
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