Avandia

About Avandia

Avandia, approved by the FDA in 1999, was developed to help control blood sugar in adults with Type 2 Diabetes. The drug is used by millions worldwide.

In 2007, The New England Journal of Medicine detailed an analysis of clinical trials suggesting that the drug significantly increases the risk of heart attacks and cardiovascular death. The study was conducted by doctors at the renowned Cleveland Clinic and was published on May 21, 2007.

The trials compared patients taking Avandia with those not using the drug. The results indicate that Avandia users had an increase of cardiac-related deaths by 64 percent and 43 percent increase in heart attacks.

On May 21, 2007, the U.S. Food and Drug Administration said patients taking Avandia, especially those with heart disease or at high risk of heart attack, should talk to their doctor about the risks. Since the drug was approved, the FDA has monitored several heart-related adverse events associated with Avandia, such as fluid retention, edema and congestive heart failure.

If you or someone you know have/has taken Avandia and may be suffering or injured - Please feel free to fill out our Confidential Questionnaire Form or CALL US AT 1-888-766-2690

Avandia Comes Under New Criticism

From: LA Times

The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week.

They wrote in the journal Pharmacoepidemiology and Drug Safety that a review of adverse events reported to the Food and Drug Administration found 11 deaths due to liver toxicity between 1997 and 2006 associated with the drug, which is sold under the brand name Avandia. The group had petitioned the FDA in October to ban the drug because of the heart risks, and they renewed their call for action.

"Because of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug," said Dr. James Floyd of Public Citizen. He estimated that 1 in every 44,000 patients who take the drug develops liver failure.

Avandia Side Effects

Avandia and Heart Attacks

A New England Journal of Medicine article suggests that Avandia significantly increases the risk of heart attacks and cardiovascular death. The NEJM article analyzes several clinical trials that compared patients taking Avandia, used to help control blood sugar in adults with Type-2 Diabetes, with those not using the drug.

The results indicate that Avandia users had a 64 percent increase of cardiac-related deaths and 43 percent increase in heart attacks. Common Avandia side effects include:

* Cough

* Cold

* Headache

* Swelling of sinuses

* Back pain

* Fluid retention

* Increased ovulation

* Low blood sugar levels when combined with other diabetes drugs

FDA Issues Safety Alert on Avandia Dangers

May 21, 2007 - FDA

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Glaxo Trying to Nip Avandia Litigation in the Bud

Before they even step into a courtroom, lawyers for Glaxo are taking an aggressive posture against plaintiffs’ lawyers looking to drum up business over Avandia, the drug giant’s embattled diabetes drug. According to Bloomberg, Glaxo’s lawyers at Pepper Hamilton have sent letters to a handful of plaintiffs’ lawyers running TV ads soliciting clients for Avandia cases it says are false or misleading. (HT: Pharmalot Blog)

Quick Facts

Manufacturer
GlaxoSmithKline
Status
On the market
Intended Uses
Type 2 Diabetes treatment
Complications
Increased risk of heart attacks, cardiovascular problems, fluid retention, back pain

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