Anti-Cancer Drug daratumumab Places People at Risk from Hepatitis B Virus Reactivation with Fatal Outcome
OTTAWA, Ontario, Canada — Health officials in Canada with the agency Health Canada have issued a warning to oncologists and other physicians treating patients with multiple myeloma that taking daratumumab manufactured by Janssen, Inc. could reactivate the Hepatitis B virus in those patients. Health Canada is aware of two cases in which Hepatitis B reactivation was fatal. Consequently, Health Canada has issued a recall warning and will work with Janssen, Inc. to place more prominent warnings on product labels calling attention to the potentially fatal side effect from taking daratumumab
Canadian Health Authorities issued the recall warning on March 25, 2019, to oncologists and their staff who treat patients suffering from multiple myeloma that daratumumab has been proved to reactivate the Hepatitis B virus in people who believe the virus was in remission. Health Canada based its warning on the results of pre and post-marketing studies. The results of those studies showed that 15 people experienced Hepatitis B virus reactivation. Five of those cases were treated without difficulty. However, ten of the cases were labeled as serious, and two people perished from the reactivation. Health Canada said that none of the reactivation cases were Canadian cases. The agency did not say if any of the reactivation cases were found in the U.S.
Health Canada warned patients taking daratumumab to be watchful for jaundice or yellowing skin accompanied by extreme fatigue. These conditions could be a sign of Hepatitis B virus reactivation. Patients must inform their oncologists about previous bouts of Hepatitis B in their lives. On their end, physicians should run blood tests before prescribing daratumumab to their patients to determine if the patient has a low level of Hepatitis B virus. While taking the medication, any patient who develops symptoms of reactivation must contact Health Canada and Janssen, Inc. to inform them about the problems and seek medical attention immediately.
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