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?
Drug manufacturers have the responsibility of following the regulations placed on medications by the FDA. The FDA requires that drugs go through testing before they are FDA approved, and manufacturers must comply with medication labeling regulations. Because there are various regulations and laws that may be applicable depending on the jurisdiction, the type of drug, whether the drug is brand-name or generic, etc – it is important to connect with an experienced attorney who can help you navigate your case. If you have suffered injuries as a result of negligent drug manufacturing companies, connect with a lawyer today to discuss the details of your case.
Find an Experienced Lawyer Who Handles Washington D.C. Area Pharmacy Error Cases
If you or someone you love has recently been harmed because of a Maryland, Virginia, or D.C. pharmacy error or medication mistake, the experienced attorneys at Lebowitz & Mzhen are ready to help you with your case. We know how complex the laws are surrounding pharmacy error, but we approach our work with the skills and knowledge needed to help you recover damages. To date, the experienced pharmacy error and malpractice lawyers on our team have recovered over $65 million in settlements and awards for our clients, and we can help you too. If you have questions about a possible case, contact us at 800-654-1949 to schedule a free and confidential consultation with one of our attorneys today.