Europe’s medicines agency said on Thursday the label of Schering-Plough’s allergy drug Clarinex would be changed to make clear it should not be used by pregnant women.
The agency’s scientific committee has been reviewing the drug’s safety after authorities in Sweden reported 15 cases of hypospadias, a rare deformation where the opening of the penis is on the underside of the male organ.
The malformation was seen in boys born to women who had been using the company’s top-selling allergy drug, Claritin. Because this drug is similar to Clarinex, both products are under scrutiny.
Clarinex was developed this year as the patent on Claritin was ready to expire. Claritin recently became available over-the-counter.
In Memphis, Schering-Plough HealthCare Products employs about 600 people at its facility at 3030 Jackson.
Late on Thursday the European Medicines Evaluation Agency stressed that the benefits of Clarinex outweighed any risks. But it says that as a precaution the label would be changed to state that use during pregnancy was not recommended.
The agency says its scientific committee had concluded that a causal relationship between the drug and hypospadias “could neither be confirmed nor excluded.” It says a separate safety review of Claritin was continuing.
Schering-Plough says that reports of hypospadias seen in the Swedish Medical Birth Registry involved Claritin and that there had been no reports with Clarinex.
A review of published medical literature and birth registries outside of Sweden did not corroborate the findings with Claritin seen in Sweden, Schering-Plough says.