Alert: clobazam (Frisium) shortage – June 23

February 11, 2016

Last update: June 23, 2016
Canadian Epilepsy Alliance Drug Shortage Committee

click here to download a print version of the update for people living with epilepsy
click here to download clinical management information for your healthcare team

Clobazam is in short supply, but this drug is still available at some pharmacies. If inventories have become low or depleted at your pharmacy, ask your pharmacist to recheck the status of both generic clobazam and Frisium (brand name) with their suppliers.

Distributors have started receiving shipments this week of generic clobazam (Apo-clobazam, Apotex Inc.). The new stock will be spread across the country. There may restrictions on the amounts available to individual pharmacies until the supply situation stabilizes. A second replenishment of generic clobazam (Apo-clobazam, Apotex Inc.) is expected to arrive at pharmacies by early July.

It is expected that there will also be periodic shipments of the brand name product (Frisium, Lundbeck LLC) over the coming weeks as well.

Health Canada will be working with pharmaceutical manufacturers and other stakeholders to monitor status over the summer.

I take clobazam, what should I do?

  • Continue to take clobazam as indicated by your healthcare provider
    • do not skip doses
    • do not take less than the prescribed amount
    • do not make any changes in your treatment without medical advice
  • Contact your pharmacist and ask them if they will be able to refill your prescription. If inventories are low, the pharmacist may provide a partial refill initially.
  • Develop a management plan with your pharmacist and your healthcare provider in case clobazam is not available. You can share the following clinical management suggestions with your healthcare team:Clobazam Shortage / Pénurie de clobazam
  • If your pharmacy is unable to refill your prescription – ask your pharmacist
    • have they exhausted all avenues to try and find clobazam for you?
    • have they searched for generic clobazam and brand name clobazam (Frisium)?
  • If it is necessary to make changes to your treatment plan due to the shortage
    • ask for a copy of the new treatment instructions in writing
    • go over the information with your pharmacist
    • ask your pharmacist to explain the information again if the instructions are not clear
  • Continue working with your pharmacist and your health care provider until the situation is resolved in order to manage your epilepsy disorder in the safest, most effective way possible.
  • Contact your local Canadian Epilepsy Alliance agency if you need help by calling 1-866-EPILEPSY (1-866-374-5377)

Clinical management information for healthcare providers:

The Canadian League Against Epilepsy has provided suggestions for healthcare providers. This information is for situations when all supply avenues have been exhausted and there is no clobazam available. In addition to regular suppliers, pharmacies can check alternate suppliers, other pharmacies or can call the manufacturers directly. There is still supply available from the Frisium manufacturer.

Information to share with your pharmacist and your healthcare provider regarding how to manage this drug shortage (revised June 20, 2016):
English    |    French

What is being done to prevent this from happening again?

The Canadian Epilepsy Alliance/Alliance canadienne de l’épilepsie is committed to helping people with epilepsy maintain access to a safe, consistent and reliable supply of antiseizure medication. We will continue to advocate for (i) prevention of antiseizure drug shortages and (ii) improved management when shortages cannot be averted.

If you are concerned about this situation as well, please take a few minutes to write to your Member of Parliament and provincial representative (MPP) to share your concerns. Explain how a drug shortage affects you and your family.

Find your Member of Parliament (MP)      |     Find your provincial representative


Estimated Resupply Dates

There are 4 pharmaceutical companies that market clobazam in Canada.

  • Apotex Inc. (Apo-Clobazam) – partial resupply week of June20, additional supply to follow
  • Pro Doc Limitee (Clobazam-10) – not distributed in Ontario
  • Teva Canada Ltd. (Teva-Clobazam or Novo-Clobazam) – Resupply date Sept 30
  • Lundbeck (Frisium) – product is on allocation with periodic releases

Apotex Inc. posted notification of a shortage for Apo-Clobazam in early December on drugshortages.ca. No explanation has been provided. The estimated resupply date for Apo-Clobazam has changed multiple times. Initially, the resupply date was April 15, 2016 then it was extended to September 1, 2016 and then November 30, 2016. However, the newest resupply estimate for Apo-clobazam is June 17, 2016.

Pro Doc Limitee markets a private label version of clobazam at Jean Coutu pharmacies in Quebec. The estimated resupply date for Clobazam-10 is October 31, 2016. This may change now that Apotex is resupplying earlier.

Teva-Clobazam (also called Novo-Clobazam) from Teva Canada Ltd. is also on back-order and new shipments are expected to be available on September 30, 2016. Teva reported a shortage on May 16 which was after they went into back-order on this product.

Frisium is on allocation, which means that there are limits on the amount that pharmacies can order. There has been no report, so far, on drugshortages.ca from Lundbeck.

Pharmascience used to market this drug but discontinued PMS-Clobazam in April 2015.

If you need information or assistance during this shortage please contact:
Suzanne Nurse
Chair, Canadian Epilepsy Alliance Drug Shortage Committee
Email: [email protected]
Phone: 519.317.9174