Health Canada recently warned about the risk of severe, debilitating joint pain as a result of taking type 2 diabetes medications called dipeptidylpeptidase-4 (DPP-4) inhibitors.
This DPP-4 inhibitors class of drugs includes the following:
- Onglyza
- Kombiglyze XR
- Nesina
- Kazano
- Oseni
- Glyxambi
- Janumet (XR)
- Januvia
- Jentadueto
- Tradjenta
- Qtern
The FDA also issued a Drug Safety Communication in August of 2015 concerning the association of DPP-4 inhibitors and severe joint pain. They soon added the following warning to the labels for these drugs:
Severe and Disabling Arthralgia
There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate.
The FDA’s warning and subsequent label change concerning DPP-4 inhibitors sparked an extensive review of the existing medical literature on the relationship between these drugs and severe joint pain.
Based on this literature review, as well as the FDA’s actions and their Adverse Event Reporting System, Health Canada is following suit and “working with manufacturers to update the product safety information for all DPP-4 inhibitors to communicate the risk of developing severe and disabling joint pain with the use of these drugs.”
It will be interesting to see if Health Canada decides to use a strengthened version of the FDA’s warning against disabling joint pain in their own warnings.
We will continue to monitor medical news and publications for new and increased warnings of the link between severe joint pain and the DPP-4 inhibitor class of drugs.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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