FDA slow to move on diabetes drug labeling
There's a saying we have in the country that you can't put the cat back in the bag. You can't un-ring a bell, if you will.
And, yet, that seems to be the exact situation the FDA finds itself in, time and again. It commits some foolish mistake, and then scrambles in a futile effort to undo it.
After learning that two patients died from acute pancreatitis after taking exenatide (popularly known as Byetta), the FDA announced it was developing a stronger and more visible warning label. The FDA mandated a milder warning in October 2007 after accounts of 30 Byetta patients who developed pancreas problems.
Apparently, 30 sick people weren't enough to get the FDA's full attention – or even enough to mandate a prominent warning label. Hey, almost dying isn't the same thing as dying, right? So, while the FDA moved in baby steps and half measures, people continued suffering from Byetta's side effects.
This summer, in addition to the two deaths, the FDA also received reports of four cases of acute pancreatitis that required hospitalization for people who had taken Byetta. It said people should discontinue the use of Byetta if they show symptoms of acute pancreatitis, a swelling of the pancreas that can cause persistent abdominal pain and vomiting.
The FDA urged doctors to consider medications other than Byetta for diabetics. In some cases, pancreatitis developed within a week of patients initiating Byetta treatments.
The worldwide market for diabetes meds is a whopping $24 billion. More than 700,000 people with type 2 diabetes have injected Byetta since it was introduced in 2005, and it became popular because it supposedly can help diabetics lose weight. Of course, whether it helps them keep the weight off is another matter.
The revelation of new cases of pancreatitis in Byetta patients is a grim one. I hope docs will start thinking twice before prescribing it. Plenty of diabetics will be better off for it.
