U.S. Medical News: Pfizer Withdraws Millions of Nurtec ODT Migraine Tablet Packs In The United States
U.S. Medical News - Pfizer Recalls Nurtec ODT Migraine Tablets Mar 19, 2023 1 year, 1 month, 1 week, 1 day, 2 hours, 34 minutes ago
U.S. Medical News: Pfizer has initiated the withdrawal of millions of Nurtec ODT Migraine tablet packs in the United States due to the lack of necessary child-resistant blister packs, which, according to U.S. regulators, present a poisoning hazard to children.
In all, more than four million blister packs of Pfizer’s prescription migraine drug Nurtec ODT is being recalled in America due to the absence of mandatory child-resistant packaging.
Nurtec ODT is the brand name for Rimegepant, a medication used for the acute treatment of migraine with or without aura in adults and the preventative treatment of episodic migraine in adults. It is taken by mouth to dissolve on or under the tongue. It works by blocking CGRP receptors.
In the United States, rimegepant was approved for treating acute migraine in February 2020, and its approval was extended to preventing episodic migraine in June 2021.It is produced and marketed solely by Pfizer. In March 2021, rimegepant was approved for medical use in the United Arab Emirates and in Israel.
The drug is not advised for anyone below the age of 18 years of age and it can cause a variety of serious adverse effects in children including breathing difficulties.
The U.S. Consumer Product Safety Commission (CPSC) stated in a March 16 announcement, "The product's packaging is not childproof, creating a risk of poisoning if the contents are ingested by young children."
To date however, no injuries have been reported as a result of children accessing the packaging, according to the CPSC.
The withdrawn medications were required to have child-resistant packaging under the Poison Prevention Packaging Act (PPPA). The withdrawal affects 4.2 million blister packs of Nurtec ODT, each containing eight doses of 75 milligram (mg) tablets that rapidly dissolve in the mouth.
According to
U.S. Medical News coverages, the recalled blister packs have expiration dates through June 2026. These packs were sold at pharmacies across the United States from December 2021 to March 2023.
The CPSC advised all who are in possession of the drugs, "Consumers should promptly secure the withdrawn product beyond the sight and reach of children and contact Pfizer for a complimentary child-resistant pouch to store the product. Once the product is safely stored, consumers can continue to use it as directed."
Withdrawn Nurtec ODT Remains Safe To Use As Instructed
Pfizer has advised that patients do not need to discontinue their medication or dispose of any tablets. The company confirmed that there are no quality or safety concerns associated with the continued use of these tablets, as prescribed by a physician for migraine prevention or treatment.
Pfizer mentioned that it acquired Nurtec ODT from Biohaven in October 2022 and only recently discovered that Biohaven had revised the tablet packaging in late 2021.
The new packaging was not tested for child resistance, as mandated by PPPA regulations, Pfizer noted.
Pfizer's tests revealed that the packaging was not child-resistant, and the company informed consumer regulators, who approved Pfizer's proposal to have pharmacists dispense the
medication in child-resistant vials.
Although the CPSC refers to the situation as a recall, Pfizer maintains that Nurtec ODT is still available while the company develops new packaging that complies with PPPA standards.
Doctors are also stating that this recall pertains to the absence of child-resistant packaging and is unrelated to medication quality. As a result, patients do not need to discontinue the medication or seek an alternative.
Pfizer advises that Nurtec ODT must be stored safely away from children. Individuals with Nurtec ODT blister packs can contact Pfizer at 800-879-3477 to obtain free child-resistant resealable pouches for storing their medication, according to the company.
Doctors also suggest that anyone with young children at home can also take measures to secure the medication independently. They can remove the pills and place them in a child-safe container, and then store the container in a closed and locked cabinet or drawer. It should be kept away from areas where children typically spend their time.
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