Brexafemme Recall Issued Over Contamination Concerns

Machinery used to manufacture recalled Brexafemme was also used to make an antibiotic, which is known to cause anaphylaxis and other allergic reactions in some users.

Scynexis has announced a recall for the antifungal medication Brexafemme, due to concerns that the drug may have become cross-contaminated during the manufacturing process, potentially exposing users to an antibiotic that is known to cause serious adverse reactions in some users.

The Brexafemme recall was announced in a U.S. Securities and Exchange Commission filing on September 25, indicating that the same equipment used to manufacture the pills was used to make drugs that contain beta-lactam, a type of antibiotic that includes penicillin and carbapenems.

Scynexis licensed Brexafemme to GlaxoSmithKline earlier this year. However, the Brexafemme contamination problems were discovered after GSK conducted an inspection of the manufacturing facility, and determined that cross-contamination could trigger hypersensitivity or an allergic reaction in some users of the antifungal drug.

Beta-lactam Cross Contamination Risks

U.S. Food and Drug Administration (FDA) guidelines require companies to completely segregate the manufacturing of beta-lactam compounds from other drugs because they may cause hypersensitivity or anaphylaxis in some users, particularly if they have a history of allergic reactions to antibiotics.

Anaphylaxis is a severe, life-threatening allergic reaction that can occur within minutes of exposure to an allergic substance. Anaphylaxis can cause the body to go into shock. Blood pressure drops suddenly, airways close up, and difficulty breathing can occur. Some patients can become nauseous and vomit or suffer a skin rash. If not treated quickly, anaphylaxis can lead to death.

Exposure to beta-lactamase can also lead to gastrointestinal side effects like diarrhea nausea, as well as headaches, seizures, and insomnia.

To date, there have been no reports of allergic reactions or adverse health effects linked to the Brexafemme contamination.

Brexafemme (ibrexafungerp) was first approved by the FDA in 2021. It is an oral pill used to treat vulvovaginal candidiasis or the common yeast infection.

Estimates indicate roughly 75% of women will experience at least one episode of yeast infection during their lifetime.

In addition to the Brexafemme recall, the manufacturer has also placed a temporary hold on clinical studies of the drug until a strategy and resupply plan can be made. Analysts think it will take at least seven months for the company to develop a mitigation strategy, resupply the market, and resume clinical trials.

The manufacturer recommends any consumers who experience adverse reactions after using the recalled drug file a report with the FDA’s MedWatch Adverse Event Reporting program.