There’s a buzz going around the drug industry about the U.S. Food & Drug Administration (FDA) imposing a black box warning on Eli Lilly and Amylin’s Byetta – a subcutaneous injection used to treat Type 2 diabetes by lowering a patient’s blood sugar levels – as more deaths are reported due to the drug’s usage.

What’s the buzz all about?

Although Byetta has been on the market since 2005 and is used by an estimated one million diabetics, serious side effects and deaths due to the drugs usage are just now being reported. The FDA’s latest warning to healthcare professionals was on August 18, 2008 where it reported that at least six deaths have been attributed to Byetta use after patients contracted pancreatitis.

Prior to that, the FDA notified healthcare professionals in October of 2007 that it believed a link between Byetta and pancreatitis might exist after it received 30 reports of patients contracting the disease, although no deaths were reported at that time.

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Drug industry analysts are projecting that the FDA will likely force the manufacturers of the drug, Eli Lilly and Amylin, to include a black box warning on the drug – the most serious type available.

What is black box warning and what does it mean?

According to the FDA, “A black box warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that serve to remind health care professionals of a product's availability (so-called ‘reminder ads’) are not allowed for products with black box warnings.”

For consumers, a black box warning indicates that the FDA has established that serious risks are associated with the drug. For manufacturers, black box warnings equate to decreased sales as consumers switch to other medications where possible. Not surprisingly, both of the manufacturers in this situation are reporting that a black box warning is not needed.

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