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.
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