Merck Adds New Indications, Warnings to Januvia Labeling

-FDA News

10/26/2007 - The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, adding new uses and additional warnings.

Merck received postmarketing reports of patients taking Januvia (sitagliptin) experiencing anaphylaxis, angioedema and skin conditions including Stevens-Johnson Syndrome, which can be fatal, the revised labeling says. However, the company said it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.

The revised labeling also contraindicates Januvia for patients with a history of a serious hypersensitivity reaction to the drug, including anaphylaxis and angioedema.

The updated labeling says Januvia can be used as an initial therapy with metformin, as an add-on therapy to a sulfonylurea and as an add-on therapy to the combination of a sulfonylurea and metformin.

Ennis & Ennis, P.A. is representing individuals that have Stevens Johnson Syndrome due to side effects of prescription drugs. For more information about a Steven's Johnson Syndrome related lawsuit click here to contact our lawyers for a free, confidential case evaluation.