GSK Told to Update Avandia Warnings

Nov 21, 2007
By Pharmaceutical Executive Editors

Last week, FDA ruled that GlaxoSmithKline's diabetes treatment Avandia (rosiglitazone) would receive a black-box warning signaling to doctors and prescribers that the medication could increase the chance of heart attack and angina in patients. The drug has shown increased risk of cardiac ischemia in some short-term studies, while some longer-duration studies did not show the increase.

The ruling wasn't a total blow to GSK—the boxed warning will state that "there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drug." FDA also stated that it would keep Avandia on the market because it concluded that there isn't enough evidence to indicate that the risk of a heart attack or cardiac ischemia is higher for Avandia than other types of diabetes treatment. It will be up to physicians to decide whether the risks outweigh the benefits when prescribing the treatment.

"Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with FDA to conduct more studies about the safety and benefits of our medicine," stated GSK Chief Medical Officer Ronald Krall in a release.

A Black Box Is Not a Death Sentence Avandia sales have taken a dip in the last few weeks as news of the black-box warning percolated. However, some industry insiders feel that the worst thing GSK could do is pull back on marketing the drug. With more than 300 products on the market sporting black-box warnings, the label does not signal doom for a drug.

For example, Altace (ramipril) has a black-box warnings, but King Pharmaceuticals never limited the drug's promotion and the product is still a popular medication. The same can be said about many cholesterol drugs that carry black-box warnings for liver disease.

"The first thing a pharma company should never do is automatically stop how they market a drug," Brand Pharm Executive Vice President Kathy Magnuson told Pharm Exec on Tuesday. "There are obviously some advantages to the drug, and they need to keep reinforcing the positive aspects of the drug while making sure that the enlightened safety risk is explained to the public. Everybody's first impulse is to immediately stop talking about the good things, but they need to reinforce the positive aspects of the brand."

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