In an ever-changing scientific field, as new information and knowledge are gained each day, there may be important updates regarding your medications. For this reason, it is important to stay in touch with your healthcare providers about possible changes. In August 2022, the Food and Drug Administration (FDA) issued a warning to patients, caregivers, and health care professionals regarding autoinjector devices and their compatibility for use across FDA-approved glatiramer acetate injection drug products. Glatiramer acetate injection is used to treat relapsing forms of multiple sclerosis. There are three FDA-approved glatiramer acetate injection drug products on the market currently. These drug products are all available in a single-dose prefilled syringe with an attached needle, and patients can inject glatiramer acetate using only the syringe or by inserting the syringe into an autoinjector. Autoinjectors are medical devices designed to support patient self-injection of medication.
The FDA announcement lays out the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optimal for its use. According to the announcement, the drug product titled “Copaxone”, manufactured by Teva Pharmaceuticals is compatible with Autoject 2. The drug product titled “Glatopa”, manufactured by Sandoz, is compatible with the Glatopaject autoinjector device. Finally, the drug product titled “Glatiramer Acetate Injection”, manufactured by Viatris/Mylan, is compatible with WhisperJECT autoinjector device. The FDA has requested that the manufacturers update their labeling to instruct users to confirm that the autoinjector is compatible before using it to inject glatiramer acetate. Overall, patients, caregivers, and health care professionals should be sure to confirm that their autoinjector is compatible, and manufacturers should update their labeling to advise patients as such. Failure to do so can and has resulted in missed and partial doses.
What Happens if Drug Manufacturers Fail to Properly Label?