Diabetes Drug Wins New Uses

-Wall Street Journal

10/18/2007 - The Food and Drug Administration approved Merck & Co.'s diabetes drug Januvia for use in new combinations with other medicines, but the company also added information to the drug's label about reports of serious allergic reactions among some who have taken it.

Patients' reactions have included constricted airways, swelling around the lips and a potentially fatal skin condition called Stevens-Johnson syndrome.

Merck said it generally isn't possible to estimate how frequently patients were experiencing these reactions or to establish whether they were caused by the drug, which was approved a year ago.

However, FDA spokeswoman Susan Cruzan said Merck's label changes were normal information to convey to doctors and patients, and that "the level of concern is not great."

John Buse, the American Diabetes Association's president for medicine and science, called the additional label information "par for the course" and said such allergic reactions are a common side effect of many types of popular drugs.

Skin problems related to Januvia could concern doctors in part because of issues that have come up with some similar diabetes drugs in development. The FDA delayed approval of Novartis AG's diabetes drug Galvus, which is in the same class as Januvia, due to concerns about skin lesions identified in monkeys.

John Amatruda, vice president of clinical research at Merck, said monkeys didn't experience similar skin problems in studies of Januvia, and said there is "no evidence at all" that the allergic reactions in Januvia patients are related to what other companies have seen in monkeys.

The Whitehouse Station, N.J., pharmaceutical maker also won FDA approval for Januvia to be used as initial therapy along with a popular diabetes drug called metformin, as an add-on for patients who have tried a type of drug called a sulfonylurea, and as an add-on to a combination of both a sulfonylurea and metformin.

More than two million prescriptions have been written for Januvia, according to Merck. The drug is expected eventually to bring in annual revenue of at least $1 billion.

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.