Last December, Matthew was diagnosed with type 2 diabetes and his doctor prescribed Metformin, which is sold as Glucophage and commonly used to treat people with type 2 diabetes. Matthew didn’t suffer any side effects but recently began to gain weight. His doctor said that weight loss is associated with Januvia, adding that the anti-diabetic drug was “extremely safe.” Matthew’s doctor made two mistakes, which could have led to potentially fatal complications.
First, if Matthew’s doctor had done any research or read FDA alerts, he would have seen FDA Januvia Warnings from September 2009. The agency notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) “to include information on reported cases of acute pancreatitis in patients using these products.” By December 2009, the FDA had received 88 cases of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Two years later that number increased to over 200 cases.
The doctor’s second mistake was not checking Matthew’s history. “If my doctor had read the Januvia side effects and noticed that I had been previously diagnosed with acute pancreatitis, I am sure he would have just kept me on Metformin, which isn’t associated with dangerous side effects,” says Matthew. “I am disappointed with my doctor, but at the same time I make mistakes in my business, so I don’t expect perfection from him. My doctor said he now spends two or three hours a day filling out government forms so many patient details get overlooked.”
But Merck, the maker of Januvia, is very much to blame for Januvia pancreatitis. Merck never conducted safety studies in people who have a history of pancreatitis. And in 2009, the FDA warned that it is not known whether these people are at an increased risk if they take Januvia. Rather than voluntarily issue a black box warning, Merck said it “believes these [FDA] data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.” Tell that to Matthew.
“I drove to ER on January 1 after suffering acute upper abdominal pain and pain in my back,” Matthew says. “I was admitted right away and stayed in hospital for the next five days. The blood tests confirmed pancreatitis; my enzymes were through the roof. In 2002, I had pancreatitis that was due to an exploratory procedure called ERCP, where you have a scope down your throat and upper intestinal tract: Pancreatitis is a known side effect. I have no other health issues that would trigger it - I don’t drink and I wasn’t sick with flu, and I have good eating habits. Being a bit overweight is my only issue.”
The day before Matthew went to the hospital he researched Januvia and discovered its link to pancreatititis. “There was a lot of information online and there were questions on the Januvia website that said having a previous diagnosis of pancreatitis would lead to an easier recurrence - I figured there was a link. I stopped Januvia that day but the pain got worse and the damage was already done. I could tell I had full-fledged pancreatitis: it was a familiar pain.
“Hospital treatment involved hydration by IV - they give you some sort of sugar in the IV for energy - and pain meds (I got the strong stuff). I couldn’t eat for five days and lost 10 lbs (I gained half back since). They cut me loose and told me to start eating light foods gradually. I was doing OK and not getting any pain after eating. They also gave me some pepcid that keeps your stomach from growling because you aren’t eating.
“When I got home, my GP’s nurse called to see how I was. I told her I was quite sure Januvia was the problem and I stopped taking it. My next appointment is this March - I am going to confront my doctor about his mistake. And I believe that Merck made an even bigger mistake.
“I would like to get compensated from the drugmaker for my hospital pay and minor inconveniences. I had to co-pay and had some deductibles, which I expect will total about $3,000.”
READ MORE JANUVIA LEGAL NEWS
Januvia Lawsuit Update
One recent lawsuit (Dawn Mooney v. Merck & Co., Case No.: 3:13-cv-02040-AJB-MDD, United States District Court Eastern District of Missouri, in the St. Louis Division) alleges patients do not know the risk of Januvia pancreatic cancer because of Merck’s allegedly deceptive warning label. A federal panel recently combined Januvia and other diabetes drug cancer lawsuits into multidistrict litigation to expedite the legal process. The MDL is In re: Incretin-Based Therapies Products Liability Litigation, Case No. 2452, before the U.S. Judicial Panel on Multidistrict Litigation.
Januvia made $919 million in sales for Merck in the first quarter of 2012 alone.