Pfizer recalls migraine drug due to poisoning risk, packaging issues

03/21/2023 / By Belle Carter

Pfizer announced a recall of its Nurtec ODT migraine drug due to packaging issues and the risk of children being poisoned.

According to the March 16 recall announcement posted by the Consumer Product Safety Commission (CPSC), about 4.2 million packets of the migraine drug are not compliant with the child-resistant packaging mandated by the Poison Prevention Packaging Act (PPPA). Children that manage to open the packaging and swallow the tablet inside could be poisoned. Affected customers will be able to obtain a child-resistant pouch where they can store Nurtec tablets at no charge, the CPSC said.

Pfizer seconded the commission, informing Americans to “immediately secure the recalled product out of the sight and reach of children and contact Pfizer for a free child-resistant pouch to store the product.” However, the New York-based drug manufacturer clarified that the recall notice only pertains to the packaging and the drug is still safe when used correctly.

The recalled tablets had been sold in pharmacies across the U.S. from December 2021 through March 2023. According to Pfizer, the company is now creating new packaging for Nurtec compliant with PPPA requirements. In the meantime, pharmacists would place the blister packages into vials with child-resistant lids when filling patient prescriptions.

This was not the first time Pfizer recalled medicines it sold in drugstores. Back in March 2022, the Big Pharma firm recalled three medications for blood pressure – which included Accuretic and two other generic brands. The drugs were recalled after tests showed elevated levels of nitrosamines, a cancer-causing impurity also found in cured meats, in them. (Related: Pfizer recalls blood pressure pills over cancer link.)

FDA approved Pfizer’s nasal spray for migraines

Meanwhile, the Food and Drug Administration (FDA) approved the use of Pfizer’s nasal spray for migraine. A March 10 press release by the drug company touted the Zavzpret nasal spray (generic name zavegepant) as being able to provide pain relief for migraine in as early as 15 minutes. Zavzpret is anticipated to be available in pharmacies in July.

Angela Hwang, Pfizer chief commercial officer for global biopharmaceuticals, lauded the regulator’s approval. She stressed that the FDA’s approval of Zavzpret marked a significant breakthrough for people with migraine who prefer alternative options to oral medications.

“Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives,” Hwang said.

According to the Pfizer press release the spray’s most common adverse reactions were taste disorders, nausea, nasal discomfort and vomiting. The treatment is contraindicated in patients with a history of hypersensitivity to zavegepant or to any of its components. Hypersensitivity reactions, including facial swelling and hives (urticaria), have occurred within clinical studies.

Pablo Legoretta, founder and CEO of Royalty Pharma, also lauded the approval of the nasal spray for migraine. “This accelerated return on our Zavzpret research and development funding provides additional capital that can be redeployed to create long-term shareholder value,” he said.

Legoretta had a lot of reasons to be happy, however, as his company received $475 million from Pfizer following the FDA’s approval of zavegepant. According to PMLive, Royalty Pharma first signed a deal with Biohaven Pharmaceuticals in 2020 for zavegepant. It offered $250 million to bankroll research and development on the nasal spray in exchange for milestones and future royalties.

Biohaven accepted the deal, with Pfizer subsequently acquiring Biohaven in October 2022 for $11.6 billion. Given the acquisition, Pfizer inherited its new subsidiary’s deal with Royalty Pharma.

Royalty Pharma is also set to rake in profits from Nurtec – which Biohaven originally developed – as it obtained a small percentage of royalties from Nurtec alongside rights to a series of payments between 2025 and 2030.

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