Copaxone FDA Alerts
The FDA Alerts below may be specifically about Copaxone or relate to a group or class of drugs which include Copaxone.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Copaxone
Cross-Compatibility Issues with Autoinjector Devices Optional for Use with Glatiramer Acetate Injection
May 16, 2024 -- FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes a new warning that using an autoinjector that is not compatible with a specific glatiramer acetate injection product may increase the risk for medication errors, such as a missed dose or administration of a partial dose.
FDA is also alerting patients and health care professionals that some glatiramer acetate injection products may be administered using an optional compatible autoinjector, while other glatiramer acetate injection products must only be injected using the prefilled syringe. The availability of optional compatible autoinjectors for each glatiramer acetate injection drug product may change with time.
FDA will not further update the table of glatiramer acetate injection products and their optional compatible autoinjector devices included in the below CDER Alert issued on August 18, 2022.
Patients can continue to confirm the compatibility of their autoinjector by speaking with their health care professional, visiting the drug manufacturer's patient information website, contacting the drug manufacturer for more information, or referring to the autoinjector labeling. Patients should also continue to confirm their autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.
August 18, 2024 -- FDA is alerting patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses.
Glatiramer acetate injection is used in the treatment of relapsing forms of multiple sclerosis. There are currently three FDA-approved glatiramer acetate injection drug products on the market—all available in a single-dose prefilled syringe with an attached needle for subcutaneous administration. Patients may inject glatiramer acetate using only the syringe or by inserting the syringe into an autoinjector. The autoinjectors are reusable, designed to facilitate injections in patients with limited dexterity, and are available by prescription separately.
The table* below lists the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optional for use.
*Note: FDA will not further update this table as of 5/16/24.
FDA has requested that drug product manufacturers update their labeling to instruct users to confirm the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm compatibility by speaking with their health care professional or visiting the drug manufacturer's patient information website. Users should also confirm the autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced using glatiramer acetate injection products to FDA’s MedWatch Adverse Event Reporting program. Complete and submit the report online at Medwatch; or download and complete the form, then submit it via fax at 1-800-FDA-0178.
Source: FDA
FDA Alerts Patients, Caregivers, and Health Care Providers of Cross-Compatibility Issues with Autoinjector Devices That Are Optional for Use with Glatiramer Acetate Injection
August 18, 2022 -- FDA is alerting patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses.
Glatiramer acetate injection is used in the treatment of relapsing forms of multiple sclerosis. There are currently three FDA-approved glatiramer acetate injection drug products on the market—all available in a single-dose prefilled syringe with an attached needle for subcutaneous administration. Patients may inject glatiramer acetate using only the syringe or by inserting the syringe into an autoinjector. The autoinjectors are reusable, designed to facilitate injections in patients with limited dexterity, and are available by prescription separately.
The table below lists the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optional for use.
| Drug Product Name | Drug Manufacturer | Compatible Autoinjector Device |
|---|---|---|
| Copaxone (glatiramer acetate injection) | Teva Pharmaceuticals | Autoject 2 |
| Glatopa (glatiramer acetate injection) | Sandoz | Glatopaject |
| Glatiramer Acetate injection | Viatris/Mylan | WhisperJECT |
FDA has requested that drug product manufacturers update their labeling to instruct users to confirm the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm compatibility by speaking with their health care professional or visiting the drug manufacturer's patient information website. Users should also confirm the autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced using glatiramer acetate injection products to FDA’s MedWatch Adverse Event Reporting program. Complete and submit the report online at www.fda.gov/medwatch/report.htm; or download and complete the form, then submit it via fax at 1-800-FDA-0178.
Source: FDA
