- The DDP-4 inhibitor diabetes drug class includes major medications such as Merck's Januvia, AstraZeneca's (AZ) Onglyza, and Tradjenta from Lilly/Boehringer Ingelheim (BI).
- The FDA used its records from the adverse events reporting database, as well as the medical literature, to conduct a systematic review of this drug class. That review elicitied its newly issued warning on joint pain.
- In the safety alert, the FDA suggested that patients should not suddenly stop using DPP-4 inhibtors because of the warning. However, if they experience joint pain, they should contact their physicians.
Merck's Januvia is a $4 billion drug that is often used as second-line treatment after metformin has proven to be insufficient as monotherapy to control blood glucose (BG). However, other drugs in this class haven't fared as well, with struggling sales and continued concerns over safety. For example, in April, an advisory panel recommended that new warnings be added to Onglyza and Takeda's Nesina about heart-failure risk.
Nonetheless, a Merck spokesperson has sad that the risk of joint pain with its drugs, Januvia, as well as Janumet (a combo drug containing Januvia), is minimal. There's a decent chance that the FDA's warning won't dramatically decrease the use of DPP-4 innhibiors, which were first introduced in 2006—but over time, the class may continue to decline as a go-to therapeutic option, especially as new drugs continue to become available.