Product News and Recalls

FDA doing reassessment of diabetes drug

The Wall Street Journal says the U.S. Food and Drug Administration is doing a reassessment of Avandia – a diabetes drug manufactured by GlaxoSmithKline that was once regarded as a blockbuster in the pharmaceutical market.

In 2007, a study linked Avandia to heart attacks. In 2010, the FDA imposed restrictions requiring the manufacturer to advise patients of the risk information. Health-care providers must also provide documentation verifying that the risk information has been shared with each patient.

According to the Wall Street Journal, the drug’s sales plummeted after that. Annual sales, which once amounted to about $3 billion annually, dropped to just over $1.9 million last year.

Other diabetes drugs have generated health concerns in recent years.

Studies have linked both Merck’s Januvia and Bristol-Myers Squibb’s Byetta to a higher risk of pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

The U.S. Food and Drug Administration is examining unpublished findings by a group of academic researchers, which suggest a potential link between newer diabetes drugs – including Januvia and Byetta — and pancreatic cancer.

According to the Wall Street Journal, the FDA is planning a two-day hearing of outside medical advisers in June to study the results of a re-evaluation on Avandia, conducted by scientists at Duke University.

The FDA declined to discuss why the hearing is planned, but a GlaxoSmithKline spokeswoman said the company isn’t looking to ease restrictions on sales of the drug.

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.

http://online.wsj.com/article/SB10001424127887324240804578418700347247658.html