FDA Alerts – FDA warns of potential anaphylactic reaction in patients treated with glatiramer acetate (Copaxone, Glatopa)

On Wednesday, the FDA advised patients and health care providers that they would be adding a Boxed Warning to the medication glatiramer acetate, which is marketed as Copaxone or Glatopa. Patients undergoing treatment with glatiramer acetate, says the FDA, are at increased risk for anaphylaxis.

Glatiramer acetate is a drug typically prescribed to patients with relapsing multiple sclerosis. Per the Mayo Clinic, the medication is administered via injection and can increase the length of remission for some patients. Most adults receiving treatment with glatiramer acetate receive injections either once per day or three times per week. Many patients self-administer the medication via a prefilled syringe or with an autoinjector.

In response to documented cases of anaphylactic reactions, the FDA has issued new guidelines for patients, caregivers, and health care professionals regarding the risks associated with taking drugs comprised of glatiramer acetate. The FDA reminds patients and health care providers that post-injection reactions to glatiramer acetate are common and that many of these reactions resolve within 15 to 30 minutes. These transient reactions can present similarly to anaphylaxis but do not worsen or persist. Symptoms might include “flushing, chest pain, palpitations, anxiety, shortness of breath, rash, or hives.” Patients undergoing treatment with glatiramer acetate can experience a post-injection reaction at any point during treatment, regardless of the number of doses they have received.

Unlike these relatively common and minor post-injection reactions, treatment with glatiramer acetate can cause anaphylaxis on rare occasions for some patients. The new boxed warning advises the public that patients have died from anaphylactic reactions caused by glatiramer acetate. These instances of death have even occurred “years after treatment has been initiated.”

The FDA urges patients to report all new reactions and symptoms to their health care provider. Patients and caregivers should call 911 for any post-injection reactions that worsen or do no resolve within 30 minutes. No further doses of glatiramer acetate should be administered until the patient has received clearance from a medical professional. Furthermore, healthcare providers should be aware of the risks posed by Copaxone, Glatopa, and other drugs comprised of glatiramer acetate. Doctors should educate patients about the signs of anaphylaxis and the steps to take if anaphylaxis is suspected. Patients who have experienced an anaphylactic reaction to glatiramer acetate should not resume treatment with the drug.

Patients and health care providers can report any new adverse health events related to Copaxone, Glatopa, and other drugs derived from glatiramer acetate through the FDA’s MedWatch Online Voluntary Reporting Form.

 

If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a drug, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medications to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.