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Thursday March 4, 2021

 

Dear Members of our Community, 

We are writing to provide an update regarding the medication called Nalcrom and our recent discussions with Sanofi Canada. In December 2020, we were informed by members of our patient community of concerns with the quality and efficacy of the Nalcrom medication from the most recent batches. Concerns regarding the quality of the medication were raised in conjunction with concerns regarding the supply of the medication, with many patients expressing to us difficulties accessing the medication from their pharmacy. 

 

We took action by launching a survey to collect information on both the supply challenges and the quality concerns that had been raised to us. This survey launched February 12, 2021 and will remain open until March 15, 2021. 

 

Despite the survey continuing to collect responses until March 15, 2021, we took immediate steps to address this issue. Since February 2, 2021 we have participated in weekly meetings with a representative from Sanofi Canada. We shared with them the preliminary results of our survey (now 48 respondents) and advocated on behalf of our patient population  the need to investigate and promptly resolve the quality and efficacy complaints that had been raised by patients. On February 26, 2021, we sent a letter to Health Canada to make them aware of the current situation, share with them our preliminary survey results, and request their support in resolving concerns raised by our patient population related to the most recent batches of Nalcrom. Our letter has been received by the Health Canada Regulatory Operations and Enforcement Branch (ROEB) and Health Product Compliance Directorate (HPCD). Our letter has also been forwarded to the Canada Vigilance Program.  We will share any follow-up information.

 

Yesterday, March 3, 2021, we had a follow up call with a Sanofi Canada representative and were informed that based on adverse events reported by individual patients and the information we have shared with them, that they are taking additional steps to investigate and examine the next batch of Nalcrom medication that will be distributed in Canada. To ensure that they are able to conduct the reviews of the next batch that they deem necessary, Sanofi Canada on March 2, 2021 declared a temporary shortage of the Nalcrom medication. The company anticipates that the medication will once again become available to patients in Canada on April 23, 2021. We have attached to this statement a copy of the letter that Sanofi Canada has provided to all of your healthcare professionals on the matter.

 

We realize that this update will come as a disappointment to many of those in our patient population, however we  wanted to share this new information as soon as possible to allow you to make decisions based on all current information. We will share additional updates as they become available.

 

We will continue to advocate on behalf of our patient population and have ensured that both Sanofi Canada and Health Canada know that this is a medication for a rare disease population that has no generic source of accessing this medication. We encourage individuals that have concerns regarding the quality of and/or experience adverse events to the most recent batches of Nalcrom medication to inform Sanofi Canada and Health Canada directly.  You can raise concerns over a medication and file a complaint by calling Sanofi Canada at 1-800-265-7927. Regarding Health Canada you can submit an Adverse Event Form through this link. If the link doesn't work there is more information on this website about submitting your concerns directly (by email or phone).

 

Following the resolution of the current quality investigation and declared shortage we have arranged with Sanofi Canada to work collaboratively towards addressing the longstanding supply issues that patients have experienced with Nalcrom. We want to reiterate, however, that at the moment our key priority is resolving the Nalcrom medication quality concerns and the newly declared shortage. We are actively working towards ensuring that individuals living with mast cell diseases have access to Nalcrom medication as soon as possible and have made clear the current situation poses risks to this rare disease population. 

 

If the newly declared shortage will affect you or someone you are caring for we recommend that patients reach out to their prescribing healthcare professional to discuss the appropriate next steps.

 

At this time we have shared with you all of the information that we currently have about the situation, however, please do not hesitate to reach out if you have any additional questions.

Warm wishes,

 

Caitlin (on behalf of the MSC Board of Directors)

Caitlin Salvino (she/her)

Director, Mastocytosis Society of Canada

caitlin@mastocytosis.ca

 

Download:  Download the letter from Sanofi