2) A change in the Prescribing Information (the "label") seems likely. This can take months, depending on whether the manufacturer wishes to procrastinate and nitpick every suggestion that the FDA proposes, or occur almost immediately if an outbreak of integrity happens.
3) An FDA Advisory Committee meeting might be called. This is an extraordinary event for a drug that's already on the market, but a public review of the safety of Byetta seems possible in light of the importance of these events vs. the upcoming planned expansion of the use of this drug as monotherapy and as once-weekly therapy. At such a meeting, representatives from the FDA and the manufacturer (and concerned citizens) present their data to a panel of experts, who review the data and offer their opinion to the FDA about what next: continuing the present label (unlikely here), changing the label (and how to reword it), or withdrawing the drug from the market (an extreme step granted the current knowledge of Byetta's risk profile).
In the meantime, if you are taking Byetta, my advice from last autumn remains unchanged:
- Don't stop your Byetta if you're taking it simply because of this issue, unless your blood tests (amylase, lipase) are positive for pancreatitis!
- Since gut side effects are common with Byetta, and your doctor probably has had dozens or hundreds of people calling about tummy upsets on this drug, you'll have to push your doc -- ask him/her to read the FDA warning.
- Ask for a pair of blood tests called "amylase and lipase" to confirm or rule out pancreatitis.
- And finally, if you've had acute pancreatitis while on Byetta, be sure your physician reports your case to the manufacturer and/or the FDA.
Read more from our experts:
FDA Warns of Possible Link of Byetta and Pancreatitis
A Byetta Pancreatitis Perspective
