Glaxo’s Avandia may increase heart attack risk

Diabetic patients consuming GlaxoSmithKline’ Avandia, may now have to shift to some substitute drug as the popular diabetes medicine intending to keep sugar levels at bay may in fact increase the risk of heart attacks in takers, according to a study conducted by researchers at the Cleveland Clinic and published in the New England Journal of Medicine.

Rosiglitazone maleate, marketed as Avandia, is a drug that reduces glucose (sugar) level in the blood by increasing the level of insulin. It belongs to the antibiotic drug class called "thiazolidinediones” and is used to treat type II diabetes. Pioglitazone (Actos) is another member from this class.

Avandia’s drug class "thiazolidinediones” affects a gene called PPAR-gamma and helps the body to use insulin more effectively. But they also have broader effects, said Dr Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio.

This drug, approved by the FDA on May 28, 1999, is now found to have increased the risk of heart attacks by 43% and that of cardiac arrest by 64%. Questions have been raised on the safety of this entire drug class as another member of this class, troglitazone or Rezulin, was removed from the market in March 2000 due to liver toxicity. Around 63 people died from liver failure and 40 others had to get a liver transplant.

Heart experts, including Dr Curt Furberg of Wake Forest University in North Carolina, have expressed their worry and anxiety regarding the drug’s prescription by any doctor. Dr Sidney Wolfe, director of the health research group at Public Citizen, said "Avandia isn’t even that effective. The blood sugar-lowering effect (of Avandia) is actually less than for many of the other diabetes drugs.”

The findings were revealed after conducting almost 42 studies on around 28,000 people. FDA issued a safety alert on these drugs on Monday but has till now refrained to ask its manufactures to withdraw the supply of the drug from the market. Previously Vioxx, Merck and Co’s arthritis drugs were withdrawn from the market in 2004 after they were tested positive for increase in heart attacks.

In July 2001 FDA had sent a warning letter to Glaxo after finding about the risks of the drug through their own study after which the company sent out caution letters to doctors on September 6, 2001.

Glaxo has declined all such accusations and still stands for defending Avandia. They say that the drug has been adequately tested for any such side effects. The ongoing clinical trial sponsored by Glaxo, called RECORD, is designed to study heart risks and will be able to provide more information about this issue.

The study, started in 2001, includes more than 4400 people from 25 countries to be tested under the trial. The findings of the study are due to be published in 2009 but the interim success reports have been made available to FDA for evaluation, who has refused to comment on those.

Previous Avandia studies, two of which are known as DREAM and ADOPT, have tested the safety of the drug. The former study didn’t show positive results for any risk of heart attacks; however the latter shows increased rate of congestion in the heart’s of patients taking Avandia as compared to people taking other placebos.

GlaxoSmithKline is the second largest pharmaceutical company after Pfizer with its headquarters in UK. It has received a perfect score of 100 percent from the Human Rights Campaign Foundation’s in 2005.

GSK also entered into a controversy in December 2006 when a committee of obstetricians published their opinion in the journal Obstetrics & Gynecology regarding the increased risk of birth defects due to intake of the antidepressant Paxil by pregnant women.