Manufactured by GlaxoSmithKline, the medication Avandia is linked to heart attack and other severe complications. The primary ingredient in this drug, rosiglitazone, is an effective substance in treating type 2 diabetes. Its popularity was highest in 2006, when it profited $2.2 billion for the manufacturer. Since 2006, safety concerns associated with the drug have forced healthcare providers to limit its usage. The FDA has also called for updates to safety literature regarding the medication and the addition of warnings to the packaging. However, multiple FDA investigations into rosiglitazone have revealed unsettling details regarding its safety, as well as the nature of drug safety regulations in the country.
Rosiglitazone is classified as a thiazolidinedione, which is a group of drugs that increase insulin sensitivity. Like all thiazolidinedione medications, rosiglitazone binds to a certain set of receptors inside the cell. These receptors are located on the membrane of the cell nucleus and are known as peroxisome proliferator-activated receptors, or PPARs. PPARs determine some forms of DNA expression in the cell, which can affect many cellular functions. In particular, PPARs are capable of profoundly affecting the concentration of several substances in the blood, including insulin. While this can help treat diabetes, Avandia can cause heart attack, stroke, and bone fractures in some cases.
According to several patient analyses and meta-analyses, the linkage between Avandia and heart attack events is significant. A meta-analysis in 2007 concluded that patients taking rosiglitazone were at a much greater risk of developing edema and, consequently, cardiac failure. However, after reviewing the study, the FDA concluded that because it did not seem to cause greater risks than similar drugs on the market, it did not need to be restricted from consumers. In 2010, though, the FDA’s associate director of drug safety, David Graham, stated that the medication needed to be removed from shelves. He cited a study containing more than 220,000 patients on the medication, which showed that Avandia was linked to heart attack 500 more times than its main competitor every month.
Even with this information, the FDA still hasn’t demanded a recall or barred the sale of rosiglitazone in the country. This has been met with major controversy, especially in light of troubling actions taken by GlaxoSmithKline to keep it on the market. Multiple reports suggest that the manufacturer intimidated doctors and other healthcare providers who have attempted to criticize the medication. Also, an FDA review panel investigating rosiglitazone in 2010 produced a mixed vote on whether or not to keep the drug on the market. One of the members of the panel who voted to keep the drug on the market was later found to be paid by GlaxoSmithKline as a speaker. This has raised significant questions regarding any conflict of interest.
The Senate Finance Committee also investigated the linkage between Avandia and heart attack events, and produced troubling findings. The committee discovered multiple e-mails circulated within the company that showed GlaxoSmithKline was aware of side effects related to the drug since 2000. Congress and the FDA are still investigating the manufacturer for further wrongdoing. This act of gross negligence has resulted in many lawsuits being filed against the company. GlaxoSmithKline has already paid out hundreds of millions of dollars to victims, and this number is expected to climb much higher.