FOOD AND DRUG ADMINISTRATION WARNS OF SEVERE JOINT PAIN WITH DIABETES DRUGS

September 9, 2015

Here’s an important alert for patients taking any of the relatively new diabetes medications known as dipeptidyl peptidase-4 inhibitors, also called gliptins. The medications in this group, approved for the treatment of Type 2 diabetes, are:

• alogliptin (NESINA)
• alogliptin and metformin (KAZANO)
• alogliptin and pioglitazone (OSENI)
• linagliptin (TRADJENTA)
• linagliptin and empagliflozin (GLYXAMBI)
• linagliptin and metformin (JENTADUETO)
• saxagliptin (ONGLYZA)
• saxagliptin and metformin extended-release (KOMBIGLYZE XR)
• sitagliptin (JANUVIA)
• sitagliptin and metformin (JANUMET)
• sitagliptin and metformin extended-release (JANUMET XR)

Public Citizen’s Health Research Group classifies all of these drugs as Do Not Use because their risks of acute pancreatitis, severe skin allergic reactions, possible kidney injury (with sitagliptin)[1] and possible liver toxicity (with alogliptin)[2] outweigh their limited benefits in reducing blood sugar levels.

On Aug. 28, the Food and Drug Administration (FDA) released a warning on the risk of severe and disabling joint pain associated with the use of gliptins.[3] This adds yet another reason not to use any of these medications.

The FDA based its alert on 33 cases, reported to the FDA from 2006 through 2013, of severe and disabling joint pain in patients taking gliptins. All patients in these cases experienced a substantial reduction in their normal activity levels, and 10 were hospitalized due to disabling joint pain. Some of the patients also had fever, chills, rash and swelling.

Several factors implicate the gliptins as the cause of the joint pain. In most cases, the pain started within one month of starting the drug (though in other cases, the pain did not begin for years ) and resolved within one month of stopping the drug. In addition, eight patients who stopped the drug experienced a recurrence of the joint pain when they were put back on either the same or another gliptin. No other definitive cause could be identified in any of the cases.

The FDA also identified five additional cases from the medical literature that described patients with similar joint pain after beginning a gliptin.

The agency has updated the product labels for all gliptins to carry a warning of severe joint pain. However, this is not in the form of a prominent black-box warning and may be missed by both physicians and patients.

What You Can Do

Do not use any of the gliptins. If you are currently taking any of these medications, see your doctor immediately to discuss switching to another, safer diabetes drug. Do not stop taking any drug before seeing your doctor.

To see the FDA’s safety alert, visit the following link: http://www.fda.gov/Drugs/DrugSafety/ucm459579.htm.

References

[1] WorstPills.org. A Review of the ‘Gliptin’ Diabetes Drugs. Worst Pills, Best Pills News. March 2012. https://www.worstpills.org/member/newsletter.cfm?n_id=784. Accessed September 1, 2015.

[2] WorstPills.org. Type 2 Diabetes Drug Alogliptin Causes Liver Toxicity. Worst Pills, Best Pills News. August 2014. https://www.worstpills.org/member/newsletter.cfm?n_id=915. Accessed September 1, 2015.

[3] Food and Drug Administration. Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. August 28, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm459579.htm. Accessed September 1, 2015.