Parker Waichman LLP

Darzalex Hepatitis B Virus Reactivation Death

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 […]

Health Canada Issues Warning Concerning HBV Reactivation with Fatal Outcome

Darzalex hep. b virus reactivation deaths warning from health Canada

Warning From Health Canada

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.


What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I would like to thank both Benita Rollis and Shelly Davis for the wonderful job that they have done for me. They made it easy and helped through the hard times. Thank you both. Steven Lubowsky
Steven Lubowsky
a year ago
5 Star Reviews 150
Great company. If you really want to win your case - they will do it for you. Very professional.
Andre Kras
8 years ago
5 Star Reviews 150
I am very happy and grateful for the assistance to my case from the PARKER WAICHMAN law firm, very efficient and fast in solving my case. Many thanks to MARYAM GALLIZI for her kindness and commitment. 100% recommended.
Sandry Castro
6 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038