Diabetes drug OK’d, concerns remain

The Cayman Islands Diabetes Association is advising Type-2 diabetics using the drug Avandia to check with their doctor about whether to remain on the drug, amidst ongoing concerns it might increase the risk of heart problems.

On Monday, an American Food and Drug Administration advisory panel recommended that the drug should remain on the market in the US, saying its benefits outweighed its risks, despite voting 20-3 in favour of the proposition that Avandia is associated with increased ischemic risk, including heart-attack.

After hearing conflicting evidence about the drug’s safety, the panel said the controversial drug should carry a black box warning, the strongest the FDA can require, warning of cardiovascular risks.

The FDA is not required to follow the panel’s advice but it usually does.

The advisory panel was convened after a review of 42 studies, published in the New England Journal of Medicine in May, found that diabetes patients taking Avandia were at a 43 per cent higher risk of heart-attack than people taking other diabetes drugs or no diabetes medication at all.

Sylvia Perry, president of the CIDA – and a user of Avandia – has decided to keep using the drug after recently discussing its pros and cons with her doctor.

One of the problems patients like Mrs. Perry face is that the only other similar drug on the market, Actos, has also been linked to an increased risk of heart failure.

Mrs. Perry said the drug had worked well for her because it allows her body to use the small amount of insulin her pancreas produces more effectively, without lowering her blood-sugar levels.

Health Services Authority Medical Officer for Health Dr. Kiran Kumar said he is keeping his eye on the issue and is awaiting the FDA’s final verdict on the drug.

In the US, the American Diabetes Association urged patients taking the medication to consult with their physicians about its benefits and risks.

‘The ADA also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health care provider,’ it said.

According to the ADA, 20.8 million people in the US, or seven per cent of the population, has diabetes; although nearly one-third don’t realise it.

Most of those with the disease have Type-2 diabetes, a condition in which the body has a relative insulin deficiency, combined with an insulin resistance.

According to the US Centre for Disease Control and Prevention, rates of Type-2 diabetes have tripled in the last 30 years, largely as a result of increasing obesity rates.

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