Pfizer recalls millions of prescription migraine drugs due to child safety concerns

Pfizer is recalling millions of prescription migraine drugs after the U.S. Consumer Product Safety Commission found that the drugs do not meet the proper packaging requirements under federal law. These packaging issues have led to child safety concerns, including accidental overdose. The drugs were distributed between December 2021 and March 2023, and they are just now being dealt with.

Pfizer migraine drug recalled due to poor packaging that can lead to accidental overdose in children

According to the Poison Prevention Packaging Act (PPPA), all prescription drugs must contain child-resistant packaging. Approximately 4.2 million bottles of Nurtec ODT (rimegepant) were recalled because they do not contain the appropriate child-resistant packaging for their blister packs. The 75 milligram tablets disintegrate orally, and pose an accidental child poisoning risk if they are not properly sealed. Thankfully, there have been no reports of accidental poisonings.

Nurtec ODT is used to treat migraine attacks in adults with or without aura. The product contains 85.7 mg rimegepant sulfate, benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin. The most common side effects include nausea, indigestion, and stomach pain.

“The recalled prescription drugs must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children,” said the company’s notice. The company responsible for the packaging error is Biohaven Pharmaceuticals. In October 2022, Pfizer acquired Biohaven Pharmaceuticals Inc. and determined that the packaging was not up to federal standards.
Consumers are currently being advised 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.” Once the product is secured in the appropriate packaging, consumers are allowed to use it as directed.

No studies for Pfizer’s migraine drug on children

Pfizer internally determined that the drug’s packaging does not meet federal requirements. The recall allows consumers to continue using the drug because the packaging error “does not change the established safety profile of the drug when used as prescribed for its intended uses.”

Pfizer says there is no need to return the drugs to the pharmacy, and pharmacies will continue to issue the prescription in temporary vials that contain child-resistant lids. “Pfizer is quickly working to create new packaging for Nurtec ODT to comply with the necessary child-resistant packaging requirements,” the firm added. “In the meantime, pharmacists will place Nurtec ODT blister packages into vials with child-resistant lids when filling patient prescriptions.”

Because there have been no studies on the drug’s effects on children, consumers are instructed on how to handle an overdose in children if the need arises. “Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient,” Pfizer wrote “No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding.”

One of the best ways to treat an overdose or accidental poisoning is to administer activated charcoal orally. This over-the-counter supplement can be used to adsorb drugs and toxins from the stomach, preventing their absorption. This powdered supplement is great to have in the home apothecary. For more on this topic, check out Overdose.News.

Sources include:

12FT.io

CPSC.gov

PfizerMedicalInformation.com

Pubmed.gov