Amag Pharmaceuticals and partner Takeda have run into a snag in Switzerland. Japan-based Takeda is recalling a batch of Amag's anemia drug Feraheme, sold as Rienso in the Swiss market, after several reports of hypersensitivity reactions, one of them fatal.
Amag is investigating the batch and gathering data on the safety reports, the company said in a securities filing. The recall affects only that specific batch, and the batch was distributed only in Switzerland.
"This decision is based on a cluster of four post-marketing adverse event reports in Switzerland concerning hypersensitivity reactions of varying severity following the administration of Rienso from this batch," Amag said in the filing, adding that new batches won't be introduced in Switzerland until regulators approve.
Calling the recall a "precautionary measure," Takeda said that hypersensitivity reactions are known side effects of the drug and are listed in the Swiss prescribing instructions, the Zurich news site 20 minutes reported. Rienso was approved in Switzerland last August to treat iron deficiency anemia in patients with chronic kidney disease.
Swissmedic said it received the four reports of acute hypersensitivity reactions via its Vigilance surveillance system. Given the fact that only about 1,000 ampoules of the drug have been supplied in the country this year, the number of reports was "several times" higher than expected based on previous experience internationally, the agency said in a statement.
- see the SEC filing
- read the Swissmedic report
- get the Reuters news