Health Canada Issues Warning Concerning HBV Reactivation with Fatal Outcome
OTTAWA, Ontario, Canada — According to Health Canada, the agency in charge of ensuring the safety of medicines marketed in Canada in the same manner that the Food and Drug Administration does in the U.S., issued an alert on March 25, 2019 warning patients and physicians that people have experienced a “reactivation” of Hepatitis B virus despite taking Darzalex (daratumumab). Some reactivation cases have ended in death. Consequently, Health Canada has issued the warning and will work with Darzalex (daratumumab) manufacturer Janssen, Inc. to place warnings on the product labels so that physicians and other medical practitioners who administer the drug become aware of the possible side effects.
In Canada, Darzalex (daratumumab) is approved for the treatment of cancer known as multiple myeloma. Multiple myelomas affect the plasma cells of the blood growing in the bone marrow. Oncologists prescribe the drug along with other cancer and anti-inflammatory drugs to attack the multiple myeloma cancer cells. Oncologists can also prescribe the medication if the patients have tried other lines of cancer drugs but without measurable positive results.
Health Canada explained that Darzalex (daratumumab) could cause the Hepatitis B virus to reactivate in cancer patients whose Hepatitis B virus was in remission or not detected. Patients can become infected with Hepatitis B while taking Darzalex (daratumumab). Therefore, Health Canada recommended to physicians that they screen patients for the virus before prescribing Darzalex (daratumumab). Health Canada will also order Janssen, Inc. to update its product labeling to reflect the latest warnings.
Health Canada announced there are no current cases of Hepatitis B virus reactivation in the country right now. Health Canada concluded on its course of action after analyzing after market studies. In those studies, 15 cases of Hepatitis B reactivation occurred. Health Canada noted that ten of the 15 cases were severe cases and two out of the ten severe cases were fatal. Health Canada calculated the possible incidence of Hepatitis B virus reactivation in the Canadian population to be 0.2%. Health Canada directs anyone who experiences a Hepatitis B virus reactivation to contact the agency or Janssen, Inc.
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