Januvia Dropped by British Columbia, Added to Litigation

Vancouver, BCThis summer hasn’t been sunny for Merck, the Januvia manufacturer. One more Januvia side effects lawsuit joined the multidistrict litigation and the province of British Columbia is de-listing the diabetes drug.

The British Columbia Medical Beneficiary and Pharmaceutical Services Division advised Merck last month that all sitagliptin products, which include Januvia, will no longer be covered by the British Columbia Pharmacare Benefits Program as of February 2015. The provincial government has not yet announced why they are being dropped but one reason is likely because these diabetes drugs are linked to pancreatitis and Januvia cancer.

Another reason could be that similar drugs on the market do not come with dangerous and life-threatening side effects. For instance, last week the FDA approved the new diabetes drug Jardiance, which is in the class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. According to WebMD, the FDA said the safety and effectiveness of Jardiance was tested in seven clinical trials involving almost 4,500 people with Type 2 diabetes. The studies showed that Jardiance improved blood sugar levels compared to a “dummy” placebo drug. Further, the side effects seen with Jardiance included urinary tract infections and female genital infection - no mention of pancreatitis and cancer.

The agency also announced that post-marketing studies will be carried out with Jardiance, particularly focusing on cardiovascular effects and the safety and effectiveness in children. On its website, Merck said there have been no clinical studies “establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.” However, its TESCO cardiovascular clinical trial with Januvia (“A Randomized Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy”) began in 2008 and results are expected sometime this year.

Meanwhile, another Januvia lawsuit joined hundreds of other claims in the multidistrict litigation (MDL) against Merck and other manufacturers of incretin mimetics drugs such as Byetta.

Dara Goldstein filed her complaint in the MDL in the Southern District of California claiming that her late husband died from Januvia pancreatic cancer. Her wrongful death lawsuit, Goldstein vs. Merck Sharp & Dohme Corp., claims that Samuel Goldstein took Januvia for three years, up until March 2011, and this time was long enough to develop cancer and cause his death. The lawsuit further states that Merck should be held liable for failing to warn patients of the dangers of Januvia and incretin mimetics therapies, and for showing negligence in designing a defective drug in the first place. Goldstein is seeking punitive damages and loss of consortium.

All Januvia patients in the MDL claim that Januvia (sitagliptin) and/or other incretin mimetics caused their pancreatic cancer.