European Regulators Urged to Pull Avandia

We recently wrote that emerging research has added to the growing body of evidence linking the diabetes drug <"">Avandia (generic: rosiglitazone) to increased adverse health risks. That issue is cardiac, according to the LA Times. Now, the Wall Street Journal writes that the British Medical Journal just said that Avandia maker GlaxoSmithKline PLC should not have been licensed and should have been taken off the market.

A British Medical Journal (BMJ) probe just learned that, in July, the UK Commission on Human Medicines told the drug regulator in the UK—the Medicines and Healthcare products Regulatory Agency (MHRA)—to withdraw the drug because its benefits are outweighed by its risks, said the Journal.

The probe also revealed that members of a European panel reviewing Avandia, before it received approval in Europe in 2000, questioned the drug’s longer-term risks and benefits as well as GlaxoSmithKline PLC’s data indicating that the medication does not lead to increased cardiac issues versus other diabetes medications said the Journal.

Now, the European Medicines Agency is looking at the diabetes medication and will follow with a recommendation on whether the drug should remain or be taken off of the market, said the Journal, which noted that, in the United States, the US Food and Drug Administration (FDA) is making a similar decision following an advisory panel vote this summer to keep Avandia on the market with additional warnings.

As expected, GlaxoSmithKline PLC refuted BMJ’s assertions, arguing that it conducted broad research with over 50,000 patients, saying: “We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website,” quoted the Journal.

Regardless, Avandia has long been surrounded with debate concerning cardiovascular risks. Avandia is in a class of medications called thizolidinediones, which reduce body tissue insulin resistance and adjust cholesterol levels and are considered some of the strongest medications for treatment of Type 2 diabetes, noted the LA Times, previously.

A 2007 study with over 200,000 Medicare patients pointed to Avandia’s increased heart attack risks, “cardiovascular disease, stroke, and death by 30-to-40 percent,” versus other, older diabetes medications, said the LA Times. The study prompted stronger FDA label warnings, with even stronger warnings following more reports of increased risks with Avandia, said the LA Times.

It was then that the FDA panel concluded that the benefits of Avandia outweighed its risks and that it should remain on the market, but that no more patients are to be enrolled in a prospective study comparing the two drugs directly.

We previously wrote that another study linked Avandia to an increased risk of fractures. The research, which appeared in the Journal of Clinical Endocrinology & Metabolism, found Avandia increased the risk of fractures in postmenopausal women with Type 2 diabetes, as well as in men prescribed either drug with a loop diuretic. Many of the people included in the study suffered lower limb, arm, and leg fractures.

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