Following an inspection by the US regulatory authorities, Rhone-Poulenc Rorer has temporarily suspended production of Acthar (adrenocorticotrophic hormone), a medication for a rare form of epilepsy known as infantile spasm or West's syndrome.
There is now a shortage of the medication, but this should be resolved within the next couple of weeks, according to an article in the New York Times. There are no safety concerns with the product, the manufacture of which has not changed since the 1950s, but "the regulatory standards have changed," said a company spokesman.
Infantile spasm affects 3,000 children in the USA a year. ACTH is regarded as the treatment of choice, as anticonvulsants such as valproate do not appear to be as effective. Meantime, R-PR is trying to find supplies of Acthar in other countries.
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