FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Type 2 Diabetes Drug Linked to Severe Joint Pain

Sept. 4, 2015

The FDA is requiring manufacturers of DDP-4 inhibitors to add a label warning that the type 2 diabetes drugs may cause severe and disabling joint pain.

Approved in the U.S. in 2009, DDP-4 inhibitors include Merck’s Januvia, Janumet and Janumet XR, AstraZeneca’s Onglyza and Kombiglyze XR, Boehringer Ingelheim and Eli Lilly’s Tradjenta, Glyxambi and Jentadueto, and Takeda’s Nesina, Kazano and Oseni. The active ingredients sitagliptin, saxagliptin, linagliptin and alogliptin have been linked to joint pain.

The FDA’s adverse event database identified cases of severe joint paint associated with the drugs as early as the first day of use. Symptoms subsided after discontinuing, usually in less than a month, the agency says.

This isn’t the first time the safety of DDP-4 inhibitors has been called into question. In April, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met to review their safety after a postmarket trial showed an increase in heart failure hospitalizations of patients who took Onglyza (DID, April 13). — Kellen Owings