Pfizer is recalling more than four million blister packs of its prescription migraine medication Nurtec ODT because they aren’t in required child-resistant packages.
“The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children,” said the U.S. Consumer Product Safety Commission (CPSC) in a March 16 statement.
No injuries have been reported as a result of children getting into the packaging, CPSC said. The recalled drugs were required to be in child-resistant packaging by the Poison Prevention Packaging Act (PPPA).
The recall involves 4.2 million blister packs of Nurtec ODT that contain eight doses of 75 milligram (mg) tablets that dissolve quickly in the mouth. Recalled blister packs have expiration dates through June 2026, according to CPSC. Packets covered by this recall were sold at pharmacies nationwide from December 2021 through March 2023.
“Consumers should 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,” CPSC said. “Once the product is secured, consumers can continue to use it as directed.”
Recalled Nurtec ODT Is Still Safe to Use as Directed
In the case of the current recall, patients don’t need to stop taking their medicine or throw away any tablets, Pfizer said in an emailed statement to Everyday Health. There are not any quality or safety issues with continuing to use these tablets as directed by a doctor to prevent or treat migraines, Pfizer said.
Pfizer said it acquired Nurtec ODT from Biohaven in October 2022, and that the company only recently learned that Biohaven had updated the packaging for the tablets in late 2021. The updated packaging wasn’t tested for child resistance as required by PPPA regulations, Pfizer said. Pfizer tests found the packages weren’t child resistant and alerted consumer regulators, who approved the company’s plan to have pharmacists place the medicine in child-resistant vials for dispensing.
Even though CPSC describes the situation as a recall, Pfizer said that Nurtec ODT remains available while the company works to develop new packaging that meets PPPA standards.
“This recall concerns the lack of child-resistant packaging and has nothing to do with the medication quality,” says Lauren Natbony, MD, a neurologist and the medical director of Integrative Headache Medicine of New York and an assistant clinical professor of neurology at the Icahn School of Medicine at Mount Sinai. “Thus, patients don’t need to stop the medication or switch to an alternative.”
Nurtec ODT Needs to Be Stored Safely Out of Reach of Children
People who have blister packs of Nurtec ODT can contact Pfizer at 800-879-3477 to get free child-resistant resealable pouches to store their medicine in, the company said.
Anyone with young kids at home can also take steps to secure the medication on their own, says Huma Sheikh, MD, an assistant professor of neurology at Mount Sinai Icahn School of Medicine and the chief executive officer of NY Neurology Medicine.
“They can take out the pills and put them into a canister that is children-safe, and they should then put the canister into a closed and locked cabinet or drawer,” Dr. Sheikh advises. “It should be kept away from places where children typically spend their time.”