HHP Medication Safety Watch: January 2025

This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.

• Prescription medicines

Prescription medicines

FDA warning on multiple sclerosis drug

• glatiramer acetate (makers: Teva Pharmaceutical Industries Ltd., Sandoz Group AG)

Comment: Due to reports of a rare but severe allergic reaction, the FDA has added a warning to prescribing information for glatiramer acetate, an injectable drug prescribed for multiple sclerosis. It's sold under the brand name Copaxone, and as a generic medicine, Glatopa.

The allergic reaction, called anaphylaxis, may occur at any time during treatment, though it most often happens within an hour of injection. Symptoms of anaphylaxis include difficulty breathing, hives, or swelling of the throat or face. It can be life-threatening and requires immediate treatment.

Pain patch recalled due to packaging error and risk of excessive dosage

• Fentanyl transdermal patches (distributor: Alvogen, Inc.; maker: Kindeva Drug Delivery L.P.)

Comment: The distributor of this product has recalled one lot because some packages intended to contain a single patch may contain multiple patches. Applying more than one patch could cause life-threatening breathing problems due to excessive dosage. Children, older adults, and first-time users of this medicine have a higher risk of serious side effects or death.

Fentanyl is an opioid medicine prescribed for severe and persistent pain when other treatments have not been effective.

Read additional issues of HHP Medication Safety Watch