FDA Issues Warnings on Janumet and Januvia
Merck Diabetes Drugs have Serious Adverse Reactions
Tuesday, December 8, 2020 - A laundry list of adverse reactions have been added to the labels of Januvia and Janumet, both prescribed to treat Type 2 diabetes-related high blood sugar. The FDA issued safety-related labeling changes following after-market testing that showed the drugs put patients at risk for pancreatitis, vitamin B12 deficiency, kidney failure, hypoglycemia, severe skin conditions, severe and disabling joint pain, and other dangerous side effects.
Both drugs contain the active ingredient sitagliptin phosphate. Janumet, also available in an extended release tablet called JanumetXR, contains an additional diabetes drug called metformin hydrochloride (metformin HCl).
In 2017, the FDA linked metformin HCl to serious risks, including hypotension, lactic acidosis, kidney impairment, and other serious complications, including death.
Currently, Merck is involved in a mass tort litigation for both drugs filed by plaintiffs who believe Januvia and Janumet caused their pancreatic cancer. New findings may result in additional litigation.
Neither drug is available in generic form; both are manufactured and sold exclusively by Merck. U.S. trademarks won't expire for the drugs until 2022, giving Merck exclusive rights to U.S. profits until then.
Januvia and Janumet are Merck's second and fourth top-selling drugs respectively, with total sales of more than $5.5 billion in 2019. The market for these drugs is worldwide, with Merck's latest financial reports showing that international sales make up approximately half of the drugs' profits; the other half is comprised of U.S. sales.
In addition to identifying new risks, two postmarket studies also found that neither drug is effective in treating Type 2 diabetes in children between the ages of 10 and 17 years of age.
According to Merck's annual report filed in February 2020 with the U.S. Securities and Exchange Commission, the company was hoping to extend the patents on both drugs by a few months by claiming pediatric exclusivity. The newest FDA-cited studies regarding children will likely keep the company from doing so.
The FDA routinely conducts postmarket studies on medications approved for use in the United States. When a drug is found to put patients at risk for side effects or other complications, a black box label (sometimes called a black label) is added.
Januvia and Janumet, approved by the FDA in 2006 and 2007, have received several black box labels in recent years.
If you or a loved one has suffered pancreatitis, vitamin B12 deficiency, kidney failure, hypoglycemia, bullous pemphigoid, or severe and disabling joint pain (arthralgia) after taking Januvia, JanuviaXR, or Janumet, call the experienced pharmaceutical litigation attorneys at OnderLaw. We hold drug companies accountable when they harm those who need them most.
Call 800-799-2824 for a free, no-obligation consultation. We don't get paid unless you win your case.
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