Product News and Recalls

FDA diabetes drug review is controversial

According to U.S. News and World Report, the Food and Drug Administration’s decision to reevaluate the diabetes drug Avandia is proving controversial, with some detractors accusing the agency of unnecessarily wasting taxpayer resources.

Avandia was once a top-selling medication for its manufacturer, GlaxoSmithKline. But a 2007 study concluded that it raised the risk of heart attack by more than 40 percent. As a result, the FDA imposed restrictions on Avandia in 2011, restricting its use to very sick diabetics who have enrolled in a special program.

Some other diabetes drugs from different manufacturers have generated health concerns of their own. For example, recent studies are linking Januvia and Byetta to a higher risk of an inflammation of the pancreas called pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

GlaxoSmithKline has funded a review of an earlier clinical study that served as the basis of Avandia’s federal approval in the first place, which concluded the drug was safe.

While those Duke researchers did uncover some previously unreported cases of heart complications and deaths, they concluded that Avandia did not raise the overall risk of heart disease and the conclusions of the original trial were still valid.

Now the FDA has taken the unusual step of scheduling a panel to review those findings, with the possible outcome of reversing the earlier decision to restrict Avandia’s use. But some medical professionals are accusing the agency of trying to repair the damage to its own reputation, in approving a drug that subsequently proved to be dangerous.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

See the story here:

http://health.usnews.com/health-news/news/articles/2013/06/06/fda-mulls-lifting-tight-safety-limits-on-diabetes-drug-avandia