Daratumumab, better known as Darzalex, is an intravenous medication that is produced by Janssen Biotech in order to treat a cancer known as multiple myeloma or Kahler’s disease. Kahler’s disease targets plasma cells in the bone marrow and it can be a debilitating and often fatal disease. Thanks to Darzalex, many people suffering from Kahler’s can lead normal lives. Unfortunately, health officials in Canada have instituted a Darzalex recall after it was discovered that Darzalex allowed something else to flourish: the Hepatitis B Virus.
Evidence For The Canadian Darzalex Recall
The Canadian Government’s Recall And Safety Alert issued a Darzalex recall on March 25, 2019, after discovering that the Kahler’s disease drug also put people managing Hepatitis B at risk. According to the Canadian Recalls and safety alerts page, the Darzalex recall was instituted after it was found to cause dormant or currently managed Hepatitis B viruses to become a hazard to public health once again. From the information issued, there have been at least 15 confirmed cases of Hepatitis B reactivation and there have also been at least 15 confirmed cases with two-thirds of cases being classified as serious and of that number, 20% have been fatal.
The Canadian Government is taking no chances and, in addition to issuing a Darzalex recall for any patients who have not been screened for Hepatitis B, they have published the following guidelines:
Symptoms of Hepatitis B Reactivation
- worsening fatigue
- yellowing of the whites of the eyes or skin
Protective Measures against Hepatitis B complications in patients
- Hepatitis B virus screenings should be performed on all patients before starting any treatment with Darzalex.
- For patients with evidence of Hepatitis B infection, either past or present, the signs of reactivation should be monitored during administration, and for at least six months after Darzalex treatment has concluded
In addition, Health Canada and Janssen Biotech Inc., are updating the Darzalex Monograph to include the risk of Hepatitis B reactivation on the medication’s packaging.
For more information about the dangers of Hepatitis B, see Parker Waichman’s coverage of an outbreak that occurred in New Jersey here.
The FDA Reaction To The Darzalex Recall
While the Canadian Government’s response has been strikingly quick, and efforts are being made there to address the potential Hepatitis B link to Drazalex, in the U.S. the exact opposite has occurred. On November 21, 2016, the U.S. Food and Drug Administration (FDA) approved daratumumab for exclusively the Janssen Biotech Corp in conjunction with the medications lenalidomide and dexamethasone, or bortezomib and dexamethasone in order to treat multiple myeloma.
However, instead of taking steps to limit the expansion of Darzalex’s influence, at the time of this article’s writing, the FDA has not published anything like the Canadian Government’s Darzalex recall. Instead, on March 25, 2019, the same day that the Canadian recall took place, Janssen Biotech petitioned the FDA to expand Darzalex ’s patient pool and include its use as a front-line drug for treating multiple myeloma. While this request has not been approved or denied yet, the FDA has also expanded Darzalex’s dosing privileges in the past, allowing for things such as split-dosages as recently as February 13, 2019. Additionally, there is currently no mention of any potential Hepatitis B complications on the official FDA Drazalex page.
Pursuing Compensation Following The Darzalex Recall
While the FDA and Canadian Government sort out the extent of the damage potentially caused by Drazalex, there is still a definite human cost to Hepatitis B and the complications or fatalities that result from it. If you or a loved one have suffered unnecessary complications or needless death as the result of Drazalex causing a reactivation of Hepatitis B, don’t wait. Parker Waichman LLP has teams of experienced trial lawyers who will do their very best to ensure that you receive the compensation that you deserve. Contact Parker Waichman today for a free consultation.
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