Pfizer Recalls Duavee Menopause Drug Across Multiple Countries Due to Packaging Defect

Compiled by S.Li

Amid the broader context of the COVID-19 pandemic, consumers have become more concerned about drug quality, with some even expressing doubts. U.S. experts indicate that these concerns are not unfounded, and Pfizer’s recent frequent recalls of the menopause medication Duavee have further shaken consumer confidence in drug quality.

Duavee is a therapy that combines conjugated estrogens with an estrogen agonist/antagonist, approved by the U.S. FDA in 2013 for the treatment of menopause-related hot flashes and osteoporosis.

On June 8, the UK Medicines and Healthcare products Regulatory Agency (MHRA) stated that a defect was identified in the aluminum foil laminate pouches of Duavee by the manufacturer. This defect could allow oxygen ingress, potentially reducing the solubility of the active substance, bazedoxifene acetate, thereby affecting the drug’s efficacy. Consequently, Pfizer initiated a voluntary recall of two batches of Duavee in the UK. According to information provided by the MHRA, the expiry dates for the two recalled batches of Duavee in the UK are September 2020 and August 2021, respectively.

A Pfizer spokesperson stated that the company had voluntarily recalled 11 batches of Duavee in the United States a few weeks ago, and recalled two batches in Canada in late May. Health Canada also confirmed that Pfizer notified the country of the recall of two batches of Duavee on May 20, classifying the recall as a Type II hazard, meaning “use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”

The COVID-19 pandemic has indeed heightened consumer attention to drug quality. Last week, David Light, CEO of the independent laboratory Valisure, testified before U.S. senators that the pandemic could significantly impair the FDA’s ability to conduct adequate testing of drugs manufactured at overseas facilities. Since March, the FDA has prohibited foreign inspections, allowing investigators to enter overseas manufacturing sites only for high-priority investigations. Recently, the FDA detected excessive levels of N-nitrosodimethylamine (NDMA) in certain batches of extended-release metformin, prompting it to request five pharmaceutical manufacturers to voluntarily recall their respective products in late May.

Reference Source: Pfizer Continues Recalls of Menopause Drug Duavee Over Faulty Packaging Concerns