F.D.A.: Certain diabetes meds can cause joint pain

Aug 28, 2015, 6:20 PM EDT
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The U.S. Food and Drug Administration issued a safety alert stating that some widely used treatments for Type 2 diabetes can cause severe and disabling joint pain. The category of pills is known as DPP-IV inhibitors, which include Merck & Co.’s Januvia, AstraZeneca PLC’s Onglyza, and Tradjenta from Eli Lilly & Co. and Boehringer Ingelheim GmbH. The Wall Street Journal writes:

The FDA said in the safety alert patients shouldn’t stop taking the drugs, but should contact their doctors if they experience severe and persistent joint pain. Doctors should stop prescribing the drugs to patients experiencing joint pain if the drugs are suspected of being the cause, the agency said.
The FDA said it identified cases of severe joint pain associated with the use of DPP-IV inhibitors in a review of medical literature and adverse events reported to the FDA. Symptoms usually went away after patients stopped taking the drugs, the agency said. The agency added warnings and precautions about the joint-pain risk to the drugs’ prescribing labels.
Merck’s Januvia has dominated the DPP-IV market and is the company’s highest-selling drug, generating about $1.9 billion in sales for the first six months of 2015. A combination drug containing Januvia, Janumet, had $1 billion in sales for that period.
A spokesman for Merck, Steven Cragle, said the reason the number of cases was higher with Januvia is that it was the first to market and is the most widely prescribed, accounting for about 80 percent of DPP-4 prescriptions in the United States.
"Merck takes all safety information seriously and we worked closely with the FDA on this request," Cragle said. "We are confident in the safety profile of sitagliptin."
Boehringer Ingelheim spokeswoman Emily Geary said clinical trials of Tradjenta "do not show an imbalance between linagliptin and placebo in musculoskeletal and connective tissue disorders or, more specifically, in joint disorders."
A spokesman for AstraZeneca, Andrew Davis, said the company "works with health authorities and scientific experts to help ensure patients and physicians have a clear understanding of the risk benefit profile of our medications."