Merck & Co. added warnings to its diabetes pill Januvia after some patients developed allergic conditions, including a rare, severe skin disorder.
Among the illnesses reported by Januvia users was a sometimes fatal skin ailment called Stevens-Johnson syndrome, Merck said today in a statement. Merck said there wasn’t enough data to conclude whether the drug was the cause.
Merck said some patients also suffered anaphylaxis, a severe whole-body allergic reaction that can cause a person to go into shock, and angioedema, a swelling of the skin that leads to welts. The findings are included in the drug’s prescribing information. Januvia is one of Merck’s most important new products with $144 million in sales in the second quarter.
“Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” according to the prescribing information.
There were no reports of Stevens-Johnson syndrome in Merck’s own studies involving 6,000 patients who have taken Januvia, said John Amatruda, vice president of clinical research at Merck, in an interview today.
The number of reactions reported to Merck, based in Whitehouse Station, New Jersey, and U.S. regulators was greater than what would be expected in the general population, Amatruda said. Adverse events are reported voluntarily, sometimes with little information, making it difficult to confirm them or determine whether the cause, he said.
Merck today also said it received expanded approval to market Januvia in combination with the diabetes drug metformin as a first-line treatment. Merck already sells Janumet, which combines Januvia and metformin in a single pill.
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