Byetta Deaths cause the FDA to issue stern Warning

The FDA is charged with analyzing, investigating and ultimately approving medications for release onto the marketplace, among many other functions. Even though the FDA regularly approves prescription drugs, many of them ultimately wind up back in the FDA's crosshairs because of any number of problems that the drug in question has encountered.

One of those drugs that's come under the FDA's scrutiny more than once is known as Byetta, which has been a prominent diabetes drug that was formulated and is marketed and distributed by two pharmaceutical drug companies in Eli Lilly and Co. and Amylin Pharmaceuticals, Inc. The drug was approved for release onto the marketplace in 2005, and for a time the results it returned were positive in nature.

Specifically, Byetta found itself a profitable niche within the burgeoning diabetes drug market. Overall, approximately $24 billion is spent worldwide on pharmaceutical drugs, and Byetta generated revenue of $686 million in 2007. This represented 3% of Eli Lilly's revenue and 80% of Amylin Pharmaceutical's influx of cash during that year.

However, in October of 2007, the FDA took its first of what are now two steps to further regulate the drug. The agency issued a public health alert that warned doctors and patients that Byetta had been linked to approximately 30 cases of serious, adverse side effects that mostly dealt with the patient's pancreas.

Specifically, the most severe side effects occurred in patients who developed acute pancreatitis, a condition which presents itself with symptoms that can easily be mistaken for several other conditions. These symptoms include abdominal pain, nausea and vomiting, and acute pancreatitis is a dangerous condition.

Further Action Taken

In recent days, the FDA felt compelled to take the situation with Byetta a step further, issuing a statement that required Eli Lilly and Co. and Amylin Pharmaceuticals to come up with and place a warning label on all containers of Byetta that are released into the market stream. This action was in direct response to reports of at least six additional cases of adverse effects, and two of these patients died as a result of their conditions.

Requiring a warning label on any medication is a serious step, and the only more severe step the FDA can take is to require that a drug be recalled from the marketplace. No such recall requirement by the FDA or any voluntary recall by the manufacturers has yet taken place.

Your Next Steps

If you have been taking Byetta, you need to seek medical attention, even if you have not as of yet experienced any adverse side effects. If you have suffered from any of the symptoms above or any others, seek immediate medical attention to discuss steps to remove the drug from your routine as soon as possible.

If you or someone you love has been injured as a result of using Byetta, you also need to contact a defective drugs attorney as soon as you can to schedule a free initial consultation. You owe it to yourself to make sure that you understand your legal rights and options, so contact an attorney today.