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Avandia Side Effects Linked To Saudi Drug Recall

March 24, 2010

Avandia Side Effects Linked to Saudi Drug Recall

Avandia, also known by the scientific name of Rosiglitazone, is an anti-diabetic drug that was first introduced in 1998 and works as an insulin sensitizer. The use of the drug makes fat cells more responsive to insulin by binding to the fat cells PPAR (peroxisome proliferator-activated receptor) receptors. The pharmaceutical company GlaxoSmithKline has been the sole marketer of Avandia, but the pharmaceutical giant’s marketing efforts have recently been suspended in Saudi Arabia due to concerns about the drug.

While this drug that has been used to treat patients with type-2 diabetes has seen billions of dollars in sales over the years, the reports of negative side effects may mean that diabetes patients, especially those in Saudi Arabia, will have to consider other medical options. Avandia shipments have been banned in Saudi Arabia for at least the next six months while the issue of harmful side effects is being looked into more closely.

The side effects that have been reported include bone fractures, congestive heart failure, risk of heart attacks, eye damage, and acute hepatitis. Saudi Arabia, specifically the Saudi Food and Drug Authority (SFDA), has the opinion that the side effects from Avandia outweigh the benefits received from taking the drug, and that there are other safer alternatives on the market for type-2 diabetes patients. While the drug will still be available on pharmacy shelves until sold, there will be no new shipments allowed for at least the next six months.

Information gathered by the SFDA during a safety evaluation has revealed that a number of FDA drug safety reviewers from the U.S. have been pushing for a recall of the drug since 2007. It also revealed that the marketer of the drug, GlaxoSmithKline, had prior knowledge of Avandia’s connection to causing heart problems but did not report this fact to U.S. drug regulators. Experts have estimated that anywhere between 60,000 and 200,000 deaths and heart attacks have been caused by the drug in the seven year period between 1999 and 2006.

Avandia is classified as a type of medication known as a thiazolidinedione agent, which is known to help regulate the blood sugar levels of people with type-2 diabetes. A similar drug to Avandia, Actos or pioglitazone, has now been cited in the SFDA report as a better alternative due to the absence of harmful side effects and the fact that it is just as effective as Avandia for people with type-2 diabetes.

A permanent recall of Avandia in Saudi Arabia will be likely unless GlaxoSmithKline can somehow convince the SFDA over the next six months that the drug is not as harmful as it has been reported.

If you or a loved one has experienced health complications or illness while using Avandia or related drugs, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.
 

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