Hersh & Hersh Represents Diabetes Patients Harmed by the Use of Avandia
In 1999, GlaxoSmithKline began selling a drug for Type II diabetes called Avandia. This medication has one active ingredient in it -- rosiglitazone.
Due to the risks of heart attack, heart failure and other serious side effects with this drug, in 2007 the FDA issued a “Black Box” warning for Avandia. Several safety alerts have also been issued by the FDA.
Black Box warnings are the strongest and most serious form of warning from the FDA. The upgraded warning emphasizes the drug Avandia may cause or worsen heart failure in certain patients.
The Black Box warning makes it clear that patients with symptomatic heart failure should not take Avandia. In some patients, the medication can make congestive heart failure worse.
The FDA is reviewing data from a study called "Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes" or RECORD. The findings from this study are expected to be reported by the FDA in July 2010.
The Black Box warning states as follows:
WARNING: CONGESTIVE HEART FAILURE (Avandia labeling with boxed warning approved 8/14/2007)
- Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.
- AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. (See CONTRAINDICATIONS and WARNINGS.)
FDSA post marketing surveillance addresses concerns of significant weight gain and edema-warning signs of heart failure sometimes leading to death associated with use of the drug Avandia.
Other serious diseases including congestive heart failure, stroke, edema, macular edema, macular degeneration, Primary Pulmonary Hypertension (PPH), and bone fractures have all been reported with Avandia usage.
Passionate Representation, Historic Results -- Hersh & Hersh has expertise representing patients who have been injured by Avandia use. If you or a loved one has been injured due to taking Avandia, please contact us or call our offices at 1-800-441-5545 for more information.
As with all prescription medications, please consult your physician for your own treatment options. Do not discontinue taking this drug without medical supervision.
Avandia Risks Can Be Serious
FDA to issue report on data from the "RECORD" study in July 2010.
FDA has issued Safety Alerts on Avandia in 2007 and 2010 which specifically warn of the potential and significant risk of heart attack and heart related deaths from the use of Avandia.
The FDA issued a BLACK BOX warning for AVANDIA labels in 2007.
Avandia is one of a class of drugs used to treat diabetes mellitus type II. Avandia acts by lowering plasma levels of insulin while increasing insulin sensitivity. Over 6 million Americans have used the drug to treat adult-onset, or type 2, diabetes.
In May 2007 the New England Journal of Medicine published a pooled analysis of over 40 clinical trials studying cardiac events and the use of Avandia. The rate of heart attack and risk of death from cardiovascular events was significantly increased in Avandia users. The study suggested that diabetic Avandia patients have a 43% higher rate of heart attack and 64% increase in the death from all cardiac events over diabetics not using Avandia. However, the study noted there were limitations to the study and recommended additional studies. In actuality, the cardiovascular risks from Avandia may be much higher than this study suggested. Other adverse effects potentially include congestive heart failure, stroke, macular edema, macular degeneration, edema, PPH and increased chest pain.
Contact Hersh & Hersh for help.
If you believe you or a loved one has suffered serious side effects associated with Avandia please keep in mind that there may be time limits on when you can commence suit. As with all medications, patients should consult a physician prior to changing or stopping any medication.