Dangerous Products – Avandia

                                                                                         

Avandia is a thiazolidinedione class drug that is used to treat "type-2" or "adult-onset" diabetes. While Diabetes is a very serious and life threatening disease the cure is actually also pretty dangerous. This drug and a number of related drugs carry the "black box" warnings on the risk of heart failure while using the drugs. From the moment the drug was approved it was monitored by the heath organizations. A number of heart-related events were similar to signals seen during the clinical trials of Avandia. It was uncertain what side effects do the drug has especially in combination with other drugs. Finally after few years of monitoring the package was updated with additional warnings. The patients who are taking this medicine are recommended to consult with their doctors before they start taking the drug. Especially if these patients have high risk of heart attack. With every year this drug gets more and more warning labels and the sales rapidly dropped from $2.2 billion in 2006 to $252 million in 4Q 2007 in the United States.

Already in September 2005 Canadian journal CMAJ has documented several occurrences of partial blindness in various spots of the angle of vision. While it can be an effect of diabetes, the magazine recommended recommends discontinuation at the first sign of vision problems. Therefore laying suspicion on both Rosiglitazone and Pioglitazone. In February 2007 an official press release based on information form the ADOPT trial, noted that there is greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide. Similar increase was also found in pioglitazone (Actos), another thiazolidinedione.

Another meta-analysis in May 2007 showed that the usage of rosiglitazone was associated with a significantly increased risk of heart attack (43% more likely) and even higher risk of death from all cardiovascular diseases (64% more likely). On May 21, 2007 first alert was issued and on July 30, 2007 the Advisory Committee of the Food and Drug Administration of the United States concluded that use of rosiglitazone for the treatment of type 2 diabetes created even more risk of heart attack. But clinical trials showed that when rosiglitazone was compared to metformin, or sulfonylurea (other medicines for diabetes treatment), there was no difference in the risk of heart attack. This caused a controversy because the data together with the meta-analysis, prompted the FDA to state that the data on the association between rosiglitazone and myocardial ischemia were inconclusive. The meta-analysis was not supported by clinical trials and that caused the controversy.

There is a big controversy between the reports on Avandia, some reports clearly show that the drug is influencing health, some show that there is no connection between heart attacks and Avandia. Still one thing is certain, compared to other dangerous drugs, Avandia still had no lawsuits and especially class-action lawsuits during its history. Maybe a big part of that is because of the warning labels that were placed at the right moment.

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