Cross-contamination of products is an issue the FDA takes very seriously and will inevitably result in product recall. But rarely, if ever, has there been a recall of a drug because it was potentially contaminated by peanut flour residue. Novartis is doing just that with some lots of its anemia treatment Promacta.
The Swiss drugmaker over the weekend announced it was recalling three lots of the 12.5 mg oral suspension of the drug because there was a risk of peanut flour contamination that occurred at a third-party contract manufacturing site. It said the tablet forms of the drug were unaffected by the recall.
The company said so far there have been no reports of reactions to the drug, but there are risks for those with peanut allergies including anaphylactic shock.
In an email today, the company said that based on a detailed assessment and comprehensive investigation, the risk of cross-contamination is low but cannot be ruled out.
Novartis spokesperson Julie Masow explained in the email that the drug is manufactured by Halo Pharmaceuticals, a contract manufacturer owned by Cambrex, which had introduced peanut flour into a pilot plant at its development site. This development site is located in the commercial manufacturing site for Promacta 12.5-mg oral suspension.
“We are actively working with the manufacturer to investigate the potential cross-contamination,” she said.
Promacta is approved to treat some adults and children with chronic immune thrombocytopenia or severe aplastic anemia, as well as some adults with hepatitis C-associated thrombocytopenia. It won the label extension for severe aplastic anemia last fall. At the same time, it was granted an FDA breakthrough designation for use in treating acute radiation syndrome, more commonly called radiation sickness, a need that would arise only in the event of a nuclear attack or accident.
When Novartis picked up the product in 2015 as part of its mega-swap and sale deal with GlaxoSmithKline, Promacta was generating only about $117 million a year. But Novartis has turned it into a significant seller. It reports that sales of Proacta and another anemia drug Revolade combined were nearly $1.2 billion in 2018.