Fatal Darzalex Hepatitis B Virus Reactivation Complications

DARALEX Suspected of Causing Hepatitis B Virus Reactivation in Cancer Patients with Fatal Outcome

OTTAWA, Ontario, Canada — Health Canada warns cancer patients suffering from multiple myeloma are at an elevated risk of Hepatitis B virus reactivation while taking the anti-cancer drug DARZALEX. Janssen, Inc., the company that manufactures and markets DARZALEX, has joined Health Canada in warning patients about the possible adverse effects of taking DARZALEX. Any multiple myeloma patient who once experienced symptoms of Hepatitis B virus must alert his or her oncologist to that pertinent medical history. Janssen, Inc. vowed to work with Health Canada on this safety recall to include warnings on the DARZALEX label to draw attention to the potential side effects caused by the medication.

Health Canada is a governmental agency in Canada that performs functions similar to the FDA in the United States. In that capacity, Health Canada monitored both clinical and post-market trials of DARALEX for possible health concerns. Health Canada observed that 15 cases of Hepatitis B virus reactivation occurred during the clinical and post-market research periods. Health Canada stated that out of the 15 cases of Hepatitis B virus reactivation in patients taking DARALEX, ten were described as severe cases. Two people who developed severe cases of Hepatitis B virus reactivation died from the infection. Health Canada announced that there were no Canadian cases of Hepatitis B virus reactivation and that the total percentage of cancer patients who took DARZALEX and developed Hepatitis B was 0.02%.

Janssen, Inc. manufactured DARZALEX for use with other anti-cancer drugs to combat multiple myeloma. Information developed through clinical and post-marketing trials reveals people who once had a Hepatitis B viral infection and are in remission or have the virus at almost undetectable levels are at risk for getting another infection. Consequently, Health Canada counseled oncologists to run blood tests for Hepatitis B virus before prescribing DARZALEX. Health Canada stated that no Canadians currently experienced Hepatitis B virus reactivation. The announcement was silent as to whether any American patients experienced the unexpected side effect.

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