Heart Disease Warnings Included in Labeling for Diabetes Drug Avandia
By Jim Greene
Published on December 31, 2009
Warning labels on the diabetes drug Avandia® (rosiglitazone maleate), marketed by GlaxoSmithKline (GSK), caution that the medication can cause or worsen heart disease and that those who have experienced heart failure cannot be started on the drug. According to several lawsuits filed against GSK, the warnings came too late for some.
Concern about Avandia® centers on possible damage to the muscles of the heart wall, responsible for maintaining blood circulation. The warnings advise caution for those with a history of chronic congestive heart failure, heart attack, angina, fluid in the lungs, edema, anemia, high cholesterol, and several other conditions.
Cardiovascular Warnings Required FDA Intervention
Some plaintiffs who claim damage from Avandia® fault GSK for not including cardiovascular side effects warnings when the drug was first released, in 1999. The actions claim the warnings only appeared in 2007, when they were ordered by the U.S. Food and Drug Administration (FDA).
Avandia® is used to control blood sugar levels in patients with type 2 diabetes, but it is advised that it not be used by those with type 1 diabetes. Also advised not to take it are those with very high blood glucose, heart failure, or past or current liver disease.
Additional Side Effects Listed for Approved Patients
Those who are cleared to take Avandia® are warned that it may cause blurred vision, dizziness, or drowsiness, because of extremely low or high blood sugar levels. Users are advised not to drive, use machinery, or perform any activity that requires alertness or clear vision until they are certain they can do so safely.
If you or someone you know took Avandia® and suffered new or worsened heart disease or other health problems associated with this medication, you need to contact an experienced personal injury attorney. This is especially true if your injury occurred before GSK was forced by the FDA to include warnings about cardiovascular damage in its packaging and advertising. You may be eligible for financial compensation to help you deal with the consequences of taking Avandia® without adequate warning of possible side effects.
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