Legal Nurse Consulting News: The Controversy and Adverse Effects of Avandia
Monday, August 23, 2010
The anti-diabetic drug Avandia (Rosiglitazone) had been under review due to new information suggesting additional hazards associated with the drug. In particular, it may result in an increased chance of heart failure. Avandia works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. In a report given back in November of 2007 (Parker Waichman Alonso LLP), the American Diabetes Assocation's board updated its 'consensus statement' on the use of oral diabetes medications due to the increased heart attack risks linked to some diabetes medicines, such as Avandia. The revised consensus statement reads in part: 'New information suggests additional hazards associated with the use of either thiazolidedione, and rosiglitazone (Avandia) in particular may result in an increased frequency of myocardial infractions....We therefore recommend greater caution in using thaizolidediones, especially in patients at risk of or with, congestive heart failure.' There have been over 13,000 lawsuits against GlaxoSmithKline due to effects of this drug. In 2010, the Cleveland Clinic published an analysis of 42 clinical trials which showed that patients taking the drug had a 43% higher risk of having a heart attack. As of July 2010, GSK has agreed to settlements on more than 11,500 of the suits against them. According to the FDA panelists, the committee voted 20-12 with 1 absentation that the diabetes drug can continue to stay on the market, but they urged the agency to impose new restrictions and warnings on use of the drug. The drug's patent expires in 2012.As a Product Safety Specialist it is important to be aware of the adverse effects of this drug. Since Avandia remains on the market, it is important to be aware of the side effects linked to Rosiglitazone. Some of which include: heart failure, swelling, weight gain, liver problems, nasea/vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, yellowing of your skin or the white in your eyes, increase risk of pregnancy, fractures, anemia, hypoglycemia, and hepatotoxicity.There are thousands of cases out there that are linked to this drug and drugs just like this. With the pharmaceutical companies working hard to get new drugs on the market by the dozens, it is easy to see why it is vital to cases to have Certified Product Safety Specialists involved. So many of these drugs get passed through inspections and fall under that radar until the public speaks up and begins to file lawsuits. Until the regulations of the FDA are strengthened and regularly enforced, we will continue to see an increase of prescription related deaths and injuries.