Seroquel Settlements Continue…but What Drug is Next?

September 2nd, 2010. By LucyC

During the past few weeks we have seen AstraZeneca (AZ) settle some 17,500 Seroquel lawsuits—give or take. That puts them about two thirds of the way through a staggering 26,000 cases currently pending against them. So far the estimated amount of those settlements is around $198 million, according to media reports. That certainly isn’t chump change. But then the drug reportedly did about $4.9 billion in sales last year. You do the math. 

According to a report on Bloomberg, AZ is still facing “at least 8,000 cases in both state and federal courts.” The cases allege that the drug, which was approved by the federal Food and Drug Administration for treatment of schizophrenia and mania associated with bipolar disorder, causes—or at least is associated with—the onset of diabetes. All the settlements so far have been negotiated out of court, so this week it was decided to give AZ a little more time to see if they could finish the job—settle all the outstanding cases—without having to go to court. We’ll see. 

The average amount of the settlements per case is around $11,000. I wonder how much diabetes medication that buys?

But it seems that Seroquel isn’t the only drug associated with the development of adverse health effects. Januvia and Janumet (sitagliptin) are diabetes medications that seem to be causing some concern over the possibility that they may be associated with the development of acute pancreatitis. 

Pancreatitis is the sudden inflammation of the pancreas, and can be considered dangerous, if not life-threatening. On September 25, 2009, the FDA issued a warning to healthcare professionals stating that it was revising the prescribing information “for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. 

Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 

Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009.” (fda.gov) 

Just in case you’re wondering, the signs of pancreatitis include upper abdominal pain that may radiate to the back, abdominal pain that feels worse after eating, nausea, vomiting, tenderness of the abdomen. According to the National Institute of Diabetes and Digestive and Kidney Diseases website, “The pain may be mild at first and feel worse after eating. But the pain is often severe and may become constant and last for several days. A person with acute pancreatitis usually looks and feels very ill and needs immediate medical attention.” Terrific. Like you don’t have enough to worry about if you’re diabetic. 

Right now there’s no conclusive evidence to indicate that sitagliptin does cause acute pancreatitis. But as we’ve seen with a host of other drugs, most recently Seroquel with diabetes—and Paxil-related birth defects, a lack of clinical studies showing a link doesn’t mean to say there isn’t a link. So, we’ll just have to wait and see. As usual.

Tags: FDA, Janumet, Januvia, Seroquel

This was posted on Thursday, September 2nd, 2010 at 12:22 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.