Drug Recall Lawyer Blog

Here are some of the stories we’re following this week:

• Janumet: Shearlings Got Plowed reports that the FDA is revising the label for Janumet to warn about pancreatitis. A link to the FDA’s prescribing information is here
• Seroquel: Tom Lamb reports on the difficulties that plaintiffs are facing in these cases, of late. It seems that the odds are against us and the situation is grim—a good time for a reversal
• Prempro: NPR reports on the marketing masquerading as research by drug-makers trying to profit from menopause
• Levaquin: The Mass Tort Defense blog reports on the status of the bellwether trials: consolidation rejected
• Conflicts of Interest: The New York Times reports that Pfizer gives $3 million to Stanford University for creation of continuing medical education courses, where Pfizer has no say on what the money is spent for. Does this prevent conflicts of interest or is it “self-satirizing?”

Happy Monday!

Not drug related, but Happy Anniversary is in order.

Now that you know more about me than you are probably comfortable with (who celebrates that?), let’s get to business with some noteworthy items:

• Reuters discusses the FDAs investigation of using drugs like Seroquel on children.
• Recently expanded indications for Seroquel by children.
• The Chicago Tribune writes about abuses in prescribing psychotropic medications without consent and without a valid medical reason. Note the front-and-center picture of Seroquel.
• The Wall Street Journal discusses a clinical study showing that an experimental once-a-week treatment woks better to treat type-2 diabetes than Januvia.
• Tomorrow (December 8, 2009) the FDA will convene a joint meeting of the Cardiovascular and Renal Drugs Committee and Drug Safety and Risk Management Advisory Committee. They will discuss safety as it pertains to Gadolinium-based contrast agents, which are used before MRI procedures. A copy of the background material (agenda, briefing information and meeting roster) is located here. More information on Gadolinium-based contrast agents can be found at our blog and our website.
• More on Ghostwriting (courtesy Brian Ketterer). I like this excerpt:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Happy Monday!

We've reported on numerous drugs that are linked to pancreatitis. These include:

• Januvia and Janumet
• Seroquel
• Byetta

The signs and symptoms of pancreatitis (information courtesy the Mayo Clinic) are listed below.

On Friday, the FDA issued a warning to healthcare providers about diabetes drugs Januvia and Janumet, manufactured by Merck & Co., Inc. These drugs are in the class known as sitaglipins, and are designed to help treat patients with type-2 diabetes and type-2 diabetes mellitus. Post-marketing surveillance reveals that the drugs may be associated with acute pancreatitis after reports of 88 patients experiencing that condition between October 2006 and February 2009.

A lot of drugs are linked with acute pancreatitis, these days (see Seroquel and Byetta). Symptoms to look for include:

• Upper abdominal pain that may radiate to the back
• Abdominal pain, especially after eating
• Vomiting and Nausea
• Abdominal tenderness

Pancreatitis can be fatal if left untreated, so patients on Januvia or Janumet who experience these symptoms should be closely monitored by their healthcare providers.

For more information, see our main Januvia and Janumet Diabetes Drug website.