Federal drug regulators are warning that side effects of Januvia, Onglyza, Nesina and other similar diabetes drugs may cause users to experience severe and debilitating joint pain, which could surface months after they start using the medication.
In a drug safety communication issued on August 28, the FDA indicates that new joint pain warnings will be added to a class of diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
The agency warned that in some cases the pain may be severe enough that it warrants removing individuals from the drug, but cautioned that consumers should not stop taking their diabetes medication without first speaking with their healthcare provider.
DPP-4 inhibitors currently on the market include Januvia, Onglyza, Nesina and Tradjenta. There are also a number of combination treatments that involve the active ingredient from one of those four drugs, such as Janumet, Kombiglyze, Glyxambi, Jentadueto, Kazano and Oseni.
The medications are widely prescribed to control high blood sugar among adults who have been diagnosed with type 2 diabetes, working by forcing the body to increase the level of hormone insulin produced after eating.
At least 33 cases of severe arthralgia have been linked to DPP-4 use among cases submitted to the FDA Adverse Event Reporting System (FAERS) since October 16, 2006, with the vast majority involving Januvia joint pain problems, as that is the most popular drug in the class.
Most health experts agree that the FAERS database only receives a small fraction of the total number of actual adverse events experienced by patients, with some estimates indicating that there are likely 10 times as many actual events than get reported.
In about two thirds of the reported cases, patients began experiencing symptoms within one month of beginning treatment. However, some cases of joint pain did not begin until 44 days to up to a year after the individual began using the drug.
In most cases, symptoms resolved when the user was taken off of the drug. In some cases, the patients restarted the DPP-4 treatment and the pain did not return.
Consumers are being advised to contact their doctor immediately if they develop severe and persistent joint pain on Januvia, Onglyza, Nesina or other similar diabetes drugs.
Doctors are being warned about the risk of joint pain to make them aware that it could be linked to any DPP-4 inhibitors a patient may be taking. The FDA advises them to consider taking patients who experience such pain off the medication and trying a different diabetes drug.
Januvia (sitagliptin) is Merck & Co.s best-selling drugs and one of the best selling drugs on the market. It brought the company $1.9 billion in sales in just the first half of 2015. Janumet, a combination of Januvia and Metformin, raked in another $1 billion for the company.
In recent years, the drug maker has faced a number of Januvia lawsuits alleging that inadequate warnings were provided about the risk of users developing pancreatic cancer. The cases are consolidated as part of a federal MDL, or multidistrict litigation, before U.S. District Judge Anthony J. Battalglia in the Southern District of California to reduce duplicative discover, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.