A couple of days ago the Food and Drug Administration sent out an alert that it suspects a connection between some of the 30 reported cases of pancreatitis among people with diabetes who take Byetta and the fact that they are taking it. The FDA’s alert disturbed Wall Street.
Amylin Pharmaceuticals, which developed Byetta, on Tuesday saw its stock drop sharply. It went from about $48 per share to $43.95 before bouncing back to close at about $46 today.
Pancreatitis is definitely a serious complication. If you have “persistent severe abdominal pain which may or may not be accompanied by vomiting,” the FDA says to get immediate medical treatment. That’s true, of course, whether or not you are taking Byetta.
But people who are more familiar with Byetta than most investors – including those of us who are taking it, their doctors, and industry observers – are less concerned about the possibility of a connection with pancreatitis. I’ve received several email messages from Byetta users in the past couple of days, and no one I know is discontinuing it. In fact, one good diabetes resource specifically says, “Don’t stop taking Byetta. The FDA is not recommending that doctors stop prescribing Byetta. The drug is successful at treating type 2 diabetes for most people. If you have concerns about taking Byetta, discuss them with your doctor.”
If your doctor is as knowledgeable about Byetta as Dr. Joe Prendergast, an endocrinologist practicing in San Francisco, he will probably tell you to relax. Dr. Joe says that he has more than 500 patients on Byetta, and none of them ever showed signs of pancreatitis. He is not going to take any of his patients off it.
“I don’t think that it is a real serious concern,” he said on his video podcast this morning. Full disclosure: Dr. Joe wrote the forward to my forthcoming book, Losing Weight with Your Diabetes Medication: How Byetta and Other Drugs Can Help You Lose More Weight than You Ever Thought Possible.
Twenty-seven of the 30 cases reported to the FDA involved patients had at least one other risk factor for pancreatitis. One of those risk factors is drinking a lot of alcohol. Many heavy drinkers have pancreatitis, Dr. Joe says. If they are using Byetta too, he would not be surprised if they developed pancreatitis.
Industry observers like David Kliff, the publisher of Diabetic Investor, has an investor’s perspective on Byetta. He emphasized yesterday that the FDA did not state that Byetta caused pancreatitis in even all of the 30 cases.
When you keep in mind how rare even 30 reported case are in comparison with the number of people who are taking Byetta, this is “a non-issue,” Mr. Kliff says. “There are more than 700,000 patients using Byetta and 30 reports of pancreatitis. That’s 0.00428 percent or 1 case in 23,364 patients. That’s rare.”
He also points out that this report isn’t news. In fact, I’ve been reporting on it for a long time. In August of last year I responded to a comment about pancreatitis among Byetta users by directing readers to an excellent article by Kelly Close.
She reported that a Wall Street analyst found 24 unique cases of pancreatitis associated with Byetta from August 2005 through January 2006. Most telling to me was, “Only one of them was reported in 1Q06, which implies a decreasing incidence rate. Taken alone, the rate in 1Q06 is actually much lower than the rate of pancreatitis in the general population. This is contrary to what we would have expected since more people continue to start on Byetta over time.”
Now, of course, it’s six quarters later. In that time it looks like the FDA turned up just six more reports of such a connection.
Kelly also tellingly quoted another analyst, Thomas Wei of PiperJaffray, as saying that almost all diabetes drugs have reports of rare serious side effects. He specifically mentioned reports of pancreatitis with metformin.
In fact, just one day after the FDA’s alert on Byetta, Merck announced its own alert for another hot new diabetes drug, Januvia.
The company said it had received reports that some people taking Januvia had developed serious complications, including a potentially fatal skin condition called Stevens-Johnson Syndrome and other serious allergic reactions.
“It’s not possible to establish a causal relationship,” John Amatruda, Merck’s vice president for clinical development, said in an interview. “We don’t know what other medications these patients were on.”
That’s precisely the problem. We need to keep the same perspective on pancreatitis.
This article is based on an earlier version of my article published by HealthCentral.