Pfizer recalls over 4 million packages of prescription migraine medicine voluntarily

USA — Pfizer has issued a recall for 4.2 million packages of Nurtec ODT, which is used to treat migraines in adults.

The U.S. Consumer Product Safety Commission (CPSC) raised safety concerns that led to a recall alert from Pfizer Inc. due to a failure to meet child-resistant packaging requirements.

The recall includes packages with one sheet of eight tablets with expiration dates up to June 2026.

However, Pfizer has not identified any adverse events or safety concerns associated with this issue.

Patients can still take the drug as prescribed, and pharmacists will dispense it in vials with child-resistant lids.

The recall is related to packaging and does not change the established safety profile of the drug when used as prescribed.

As an interim measure, Pfizer is developing a new child-proof packaging for Nurtec ODT, which it acquired through its US$11.6 billion buyout of Biohaven Pharmaceutical Holding in 2022.

The CPSC has advised consumers to secure the recalled product out of sight and reach of children and contact Pfizer for a free child-resistant pouch to store it.

Pfizer has also instructed pharmacists to place the drug packet in a child-resistant vial. The company assured patients that there are no quality, safety, or health risks when the medicine is taken as prescribed for its approved use.

Meanwhile, in light of a predicted drop in Covid-related sales this year, Pfizer has announced a deal to acquire Seagen, a biotech company that specializes in developing cancer treatments.

The acquisition will allow Pfizer to sharpen its focus on oncology, a field it believes will be the industry’s biggest growth market.

Pfizer’s oncology portfolio currently includes 24 approved therapies, with the Seagen acquisition adding Adcetris for lymphoma, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast cancer treatment.

The acquisition, the largest biopharma buyout in three years, is expected to be completed in late 2023 or early 2024.

Pfizer’s oncology division brought in US$12.1 billion in revenue in 2022 and has 24 approved treatments, including breast cancer drug Ibrance.

The deal is expected to be completed later this year or in early 2024. However, the size of the acquisition means that antitrust regulators will likely scrutinize the deal closely.

Despite this, Pfizer CEO Albert Bourla is optimistic about the transaction and said that he doesn’t expect any issues.

According to Bourla, Seagen is expected to benefit from President Joe Biden’s Inflation Reduction Act (IRA), which introduces caps on out-of-pocket healthcare spending for elderly Americans.

This development is set to increase the number of patients that can access Seagen’s costly treatments.

Additionally, focusing on complex biotech drugs offers longer market exclusivity than pills, as it takes longer for such drugs to become subject to government price controls under the IRA.

The U.S. Medicare program will also be able to negotiate drug prices for the first time, with new prices for the initial 10 drugs selected starting in 2026.

Seagen’s complicated drugs also present challenges for competitors trying to develop cheaper biosimilar versions, thereby extending Seagen’s profitability.

This latest acquisition by Pfizer comes as the company prepares to offset a projected US$17 billion revenue decline by 2030 resulting from the expiration of patents for its top drugs, as well as a decrease in demand for its COVID-related products.

Pfizer and BioNTech’s COVID vaccine and oral antiviral treatment, Paxlovid, have earned more than US$90 billion in sales through 2022.

The acquisition of Seagen and other recent purchases by Pfizer are expected to generate over US$20 billion in combined sales in 2030.

In addition to Seagen, Pfizer has acquired Global Blood Therapeutics for US$5.4 billion, and Arena Pharmaceuticals for US$6.7 billion.

Reports suggest that Pfizer’s rival, Merck & Co, was in advanced deal talks with Seagen last year before negotiations fell apart.

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