FDA in trouble over widely used diabetic drug Avandia

May 22 2007

A diabetes pill which has been widely used since 1999 is now suspected of increasing the risk of heart attacks for those taking it.

According to a scientific analysis by researchers at the Cleveland Clinic, the drug Avandia raises the risk of heart attacks and possibly death, and they are accusing the U.S. government of failing again to protect the public from an unsafe drug.

Since the drug first came on the market eight years ago more than 6 million people worldwide have taken it to help control blood sugar levels for Type 2 diabetes, the most common form of diabetes; it is thought as many as 1 million Americans now use the drug.

The study examined the combined results of forty studies on almost 28,000 people and it has been revealed that there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication.

According to the study 65% of deaths among diabetic patients using the drug could be attributed to heart disease.

Author Dr. Steven Nissen and statistician Kathy Wolsk say the findings are frightening as two-thirds of diabetics die of heart problems, so a drug that boosts this possibility is especially hazardous for them.

The American Diabetes Association and heart experts say however that the actual risks to any single patient appear small and diabetics should talk to their doctors before stopping any medication.

Avandia is produced by the British-based drug company GlaxoSmithKline who have questioned these latest findings but do acknowledge that its own review found a 30 percent increased risk.

The company says this information was given to the FDA last year.

The FDA have now issued a safety alert and an advisory panel may be brought together to examine the latest findings but they do not intend to issue any immediate changes to the current side effect warnings on the drug's packaging.

Some Congress members have expressed alarm and are critical of the agency for not acting sooner; they have announced a hearing for June 6 on the FDA's role in the matter.

Type 2 diabetes is linked to obesity and affects 18 million Americans and 200 million people worldwide; it occurs when the body does not produce enough insulin or cannot effectively use what does produce.

Avandia was considered a breakthrough medication for blood-sugar control because it helps sensitize the body to insulin.

It is also combined with metformin and sold as Avandamet.

GlaxoSmithKline also has been testing Avandia to try to prevent diabetes in those at high risk of it, and, in separate studies, to prevent Alzheimer's disease but these new revelations have cast doubt on the prospects for prevention as well as treatment say experts.

Dr. Nissen says the risk factor is in line with a similar analysis which was found with lower doses of Vioxx.

Nissen says the results are a concern as the Avandia studies which were analyzed, were not designed to look for heart risks and many of them were short, some only 24 weeks, and risks may only appear over the longer term.

Experts say the situation reflects very badly on the FDA and how responsible their monitoring process is and represents a major failure of the drug-use and drug-approval processes in the United States.

Some critics say when the drug was initially approved, evidence of its benefits were mixed; the drug labels already warn of possible heart failure and other heart problems when taken with insulin, and Avandia also raises bad cholesterol levels, and can cause fluid retention and weight gain.

There have also been reports that some patients suffered more bone fractures, swelling of the legs and feet, and a few reports of swelling in the eye that can cause vision problems.

Glaxo meanwhile insists it has confidence in the drug's safety and effectiveness.

The study is published in the New England Journal of Medicine.