MedEffect e-Notice from Health Canada | Fibristal and Risk of Serious Liver Injury

Fibristal is a selective progesterone receptor modulator (SPRM) manufactured by Allergan Pharma Co. which is prescribed for the treatment of moderate to severe non-cancerous uterine fibroids. On March 15, 2018, Health Canada released a new MedEffect Notice indicating that, effective January 2018, Allergan Pharma Co. had updated its monograph for Fibristal to include warnings of potential severe liver damage requiring liver transplant.

Read the full Health Canada MedEffect Notice

Originally approved by Health Canada in July 2013, Fibristal was limited to use for a single 3-month treatment period. In November 2016, the drug received additional approval for long-term treatment beyond 3-months based on “the addition of long term safety and efficacy studies”.

Read the November 21, 2016 Allergan Pharma Co. press release about the broadened Health Canada approval for Fibristal.

Through its new proposed regulations, Health Canada is signalling that a new risk of natural health products (NHPs) is that of “failed efficacy”, meaning there is a risk of people taking them for a serious condition and them not working. It flows from a new meme being created by Health Canada that people will need to be protected from taking NHPs for serious conditions so that they instead take chemical drugs with “proven efficacy”. As the bureaucrats of Health Canada move to limit access to NHPs, they will not be considering the very serious side effects of the chemical drugs nor the risk of preventing people from taking natural products that are both effective and safe.

Health Canada has announced that it intends to start implementing its new proposed regulations this Fall. The right to treat your health naturally is a fundamental freedom and it is under threat. We must ask: Is it in your best interest for a “failed efficacy” standard to be implemented to ensure that natural products are not used for serious health conditions?