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FDA Erring On The side Of Precaution.

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While DDP-4 drugs used to lower blood sugar in adults with type 2 diabetes mellitus could cause the added discomfort of joint pains.
Toni Clarke in Washington reported last month that the FDA of USA identified (between Oct. 16, 2006 and Dec. 31, 2013) thirty-three cases of severe joint pain in patients DPP-4 inhibitors.
The FDA advises that patients should not stop taking their drugs but should contact their doctor if they experience severe and persistent joint pain.
Twenty-eight cases occurred with Merck’s Januvia, (sitagliptin). Merck is confident in the safety profile of sitagliptin and attributes the high number of cases, to it being the first in the market and also to it being the most widely prescribed drug, (eighty percent of DPP-4 prescriptions in the United States). Steven Cragle, spokesman said, “Merck takes all safety information seriously and we worked closely with the FDA on this request,”
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Five cases were reported with AstraZeneca Plc’s Onglyza (saxagliptin), two with Boehringer Ingelheim’s Tradjenta (linagliptin) and one with Takeda Pharmaceutical’s Nesina (alogliptin).
The FDA said that in 20 of the cases, the DPP-4 inhibitor was suspected as a cause of the pain and was discontinued within a month after the onset of symptoms. In eight of the remaining 13 cases, a period of 44 days to a year elapsed between the onset of symptoms and discontinuation of the drug.
Boehringer Ingelheim ‘s spokeswoman Emily Geary pointed out that 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.”
A spokesman for Takeda did not immediately respond to a request for comment.
E67 – Pharmaceuticals Do Not Agree With FDA, USA On Side Effects Of Dpp-4 Inhibitors –
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