Accel, Mint and Pharmascience recall some drugs over efficacy test data concerns

Three pharmaceutical companies are recalling various tablets due to concerns about the tests used to demonstrate their efficacy, Health Canada announced.

Accel Pharma, Mint Pharmaceuticals and Pharmascience are recalling the following:

  • Accel-Ondansetron ODT (4 mg and 8 mg tablets).
  • Mint-Betahistine (8 mg, 16 mg and 24 mg tablets).
  • PMS-Pirfenidone (267 mg and 801 mg tablets).

Health Canada says the move comes from concerns over bioequivalence test data, which is used to show that a pharma company’s generic prescription drug works the same as the brand-name counterpart.

Specifically, the agency says the tests for the three companies were conducted by India-based Synapse Labs, which the European Medicines Agency (EMA) determined could not be relied upon.

“The affected products can no longer be considered safe and effective,” Health Canada said.

“At Health Canada’s request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective.”

The EMA said in December 2023 that inspections of Synapse found “irregularities in study data and inadequacies in study documentation and in the computer systems and procedures to manage study data.”

Accel and Pharmascience are pharma companies based in Quebec, while Mint is based in Ontario.

Ondansetron is used to treat nausea and side effects from cancer chemotherapy, radiation therapy and surgery; betahistine is an anti-vertigo medication used to treat symptoms of Ménière’s disease; and pirfenidone is an anti-inflammatory and antioxidant medication to treat pulmonary fibrosis.

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