Diabetes drug will include warning

Thu, 04 Dec 2008
According to recent reports, the drug quality regulator in India is to ask companies carrying the drug rosiglitazone to add a serious warning to the packaging that makes patients and healthcare professionals aware of the potential risks to heart patients.

The American Diabetes Association and European Association for the study of Diabetes have both removed rosiglitazone from their lists of recommended drugs. The move has prompted the Drug Controller General of India to make the change.

A DCGI controller reportedly commented: "Rosiglitazone is under continuous focus of our pharmacovigilance expert committee. We are monitoring the drug. We have asked all manufacturers to print a warning on the label of all formulations containing rosiglitazone to caution heart patients against using the drug."

As many as 30 different pharmaceutical companies in India currently market generic versions of the drug, as well as the inventor GlaxoSmithKline. The drug has faced falling sales following controversy in the last two years.
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