AUGUST 22, 2016
Status as of August 10, 2016:
- The sole manufacturer of vigabatrin is currently out-of-stock
- The major Canadian distributors we have contacted have either very low levels of inventory or have no
- Some pharmacies still have vigabatrin in inventory
- Lundbeck LLC posted a drug shortage notice on drugshortages.ca on August 9. The reason given for
the shortage is “Unexpected manufacturing delays”.
- Both the tablets and the powder formulation (sachets) are listed on the drugshortages.ca reporting
o 500 mg Sabril tablets, drug identification number 02065819, estimated resupply date: Sept. 1
o 500 mg Sabril powder, drug identification number 02068036, estimated resupply date: Sept. 1
What is this drug used for?
The main clinical use of this drug is to treat infantile spasms. Vigabatrin is typically the first-line therapy for this
severe, infant-onset epilepsy.
Infantile spasms are brief seizures, lasting 1-2 seconds, often occurring in clusters of about 20 but up to 100
spasms can occur at a time. During a day, a child can have dozens of these seizure clusters.
Children with infantile spasms tend to experience developmental regression after the seizures begin. Infantile
spasms is classified as an epileptic encephalopathy, a condition in which the seizures and EEG abnormalities
cause deterioration in brain function. Stopping the seizures and the abnormal electrographic activity
(hypsarrhythmia) as soon as possible is crucial in order to achieve the best possible long-term outcome for these
Hormonal therapy, such as synthetic ACTH (Synacthen Depot) or high dose prednisolone, are other options that
epilepsy specialists may use to treat infantile spasms.
In adult neurology, vigabatrin is used very infrequently. However, there are small numbers of adults with epilepsy
who are on this drug. Its use is likely an indication that the person has seizures that are difficult to control and that
they have tried multiple antiseizure drugs in the past.
If you are currently taking Vigabatrin:
- If you are in need of a refill of your medication during the month of August or the first week of September, please contact your local pharmacy immediately to inquire about the availability of your medication
- Contact your health care provider right away to discuss treatment plans should the pharmacy be unable to refill your prescription
Update: June 23, 2016
via Canadian Epilepsy Alliance Drug Shortage Committee
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
o do not skip doses
o do not take less than the prescribed amount
o 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
o have they exhausted all avenues to try and find clobazam for you?
o 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
o ask for a copy of the new treatment instructions in writing
o go over the information with your pharmacist
o 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)
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, MNA, MHA or MLA) to share your concerns. Explain how a drug shortage affects you and your family. Find your Member of Parliament (MP) | Find your provincial representative
June 7th, 2016
Important NEW developments regarding the clobazam (Frisium) shortage:
There is a serious shortage of clobazam. A very severe prolonged shortage was anticipated, lasting many months, but the outlook has now changed. Health Canada held a teleconference on Friday last week that included the pharmaceutical manufacturers and other stakeholders including the CEA and CLAE.
The clobazam shortage will be resolved this month.
Pharmacists may not be aware of these recent changes yet.
Apotex Inc. the major supplier of clobazam for the Canadian market had projected their resupply date would be November 30, 2016 but Apotex will now be resupplying clobazam this month. The first resupply of Apo-Clobazam to wholesalers is expected on June 17, with subsequent batches on June 21 and June 27.
Extra Frisium should be available from Lundbeck this week.
April 22, 2016
Currently, there is some availability of generic divalproex.
According to information posted by Teva Canada Limited on drugshortages.ca, shipments of Teva-Divalproex tablets were expected to be sent to wholesalers the week of April 4 (250mg) and the week of April 18 (500mg). There has been no recent resupply of the 125mg Teva-Divalproex tablets, the estimated resupply date is May 31.
Apotex provided new updates on April 21. They are beginning to resupply Apo-Divalproex, starting with the 500mg tablets. Some inventory of this strength tablet is expected to ship to wholesalers on April 22. The estimated resupply dates for Apo-Divalproex are May 9 (500mg), May 31 (250mg) and July 31 (125mg).
Epival is expected to remain in shortage for the coming months. A recent update from BGP Pharma on drugshortages.ca indicates the estimated resupply dates for Epival are June 24 (500mg), July 15 (250mg) and August 5 (125mg).
Please note that the estimated resupply dates on drugshortages.ca are when the drug should be ready to ship from the manufacturer to distributors, add ~ 7 days transition time to get an estimate of availability in community pharmacies.
Pharmacists who are out-of-stock and have exhausted all avenues to obtain divalproex can contact Teva Canada customer service to request an emergency allocation.
Contact information for emergency requests:
Teva Canada Limited
tel (416) 291-9595
March 18, 2016
Teva Canada Ltd. will be releasing several batches of generic product, Teva-Divalproex, over the coming weeks.
Apotex Inc. and Health Canada are working to resolve the Apo-Divalproex shortage and more information is expected in the next few weeks regarding availability of this product.
The available supply is being shared across the system. Pharmacists may provide partial refills during this time to help the greatest number of patients maintain access to this important medication.
The availability of generic divalproex sodium is expected to improve over the coming weeks.
Brand name divalproex sodium (Epival) is expected to remain in shortage for several more months. The estimated resupply date for all strengths of Epival is July 22. Based on this estimate, it would reach pharmacies in late July or early August.
December 23, 2015
Currently, pharmaceutical companies are experiencing shortages of divalproex sodium. Generic formulations (including Apotex and Teva) and formulations of Epival (BGP Pharma) are affected. Shortages among generic formulations have been occurring for a longer period of time and the supply of products such as APO-Divalproex may be more depleted/unavailable.
See drugshortages.ca for full details
There is still supply of divalproex sodium available in Ontario.
Some individual pharmacies could be running low but should be able to still source some of this drug. It may require more investigation and pharmacists may need to pursue different avenues.
Distribution centres in Ontario received new shipments of Epival this week.
Teva Canada is estimating some replenishment of 125 mg Teva-Divalproex later this month. Some additional Teva-Divalproex and Epival are expected to be available for release near the end of January.
Apotex's 3 formulations of APO-Divalproex are on back-order for several more months. Apotex's current estimate for resupply is April 30. However, the estimates keey getting pushed back so I don't have great confidence in this date.
December 18, 2015
Canadian pharmaceutical companies are reporting shortages of divalproex sodium (Epival), also known as valproic acid.
As of Thursday December 17, a total of fifteen divalproex sodium shortages were posted on drugshortages.ca by Abbott Laboratories Limited*, Apotex Inc., Pro Doc Limitée, Sanis Health Inc. and Teva Canada Limited. None of the pharmaceutical companies have provided an explanation for the shortages.
This situation is a serious concern. The estimated resupply dates currently range from December 24, 2015 to April 30, 2016. These dates are estimates and could change. Drug shortages, or back-orders, at the level of the pharmaceutical companies do not always result in shortages at community and hospital pharmacies. Although the longer a shortage lasts the greater the likelihood that it could have an impact on patients.
If you or a family member have been prescribed divalproex sodium (Epival), contact your pharmacist and ask about the availability of your medication.
If your pharmacist runs into any difficulty obtaining divalproex sodium they may be able to find some from a different supplier, another drug store, or another chain.
According to the Canadian Pharmacists Association's guide on drug shortages, Step 1 is for pharmacists to exhaust every avenue to supply the medication. This may require looking beyond their regular sources of supply and contacting other wholesalers or calling the manufacturers. Your pharmacist also has access to resources and information through the Ontario Pharmacists Association.
If the situation worsens and your pharmacist is not able to locate any divalproex sodium for you, it is important to work with your pharmacist and your health care provider to manage the drug shortage in the safest way possible.
During a shortage, your pharmacist and health care provider may explore options that could include filling your prescription with a different strength tablet or substituting a different medication. If your dosing instructions change, ensure you understand the instructions and ask questions if it isn't clear.
When a drug is unavailable in Canada, Health Canada's Special Access Program (SAP) will consider requests from health care providers for access to the drug from outside the country. The SAP can be reached 24 hours a day, 365 days a year, and the program strives to process requests within 24 hours of receipt.
It is important to continue to take your medication as indicated. It can be frightening when an epilepsy drug is in short supply but skipping doses, taking less medication, or suddenly stopping an antiseizure drug is dangerous. This can lead to breakthrough seizures, more prolonged seizures or life-threatening events.
Click here for additional information about drug shortages please see our list of frequently asked questions
Click here for additional information about the Health Canada Special Access Program
* This company may be listed on drugshortages.ca incorrectly. Epival is no longer marketed by Abbott Laboratories Limited. According to the Health Canada drug product database, Epival is currently marketed by BGP Pharma. It appears that old drug shortage notifications from 2012 were re-used instead of creating a set of new notifications for the current Epival shortages.
Update - July 14th, 2015
Apo-clobazam shortage is resolved. The drug identification number or DIN is 02244638.
Please note that PMS-clobazam, marketed by Pharmascience Inc, has been discontinued and is no longer available in Canada. A notice of this drug discontinuation is posted on www.drugshortages.ca. The drug identification number or DIN is 02244474.
Acetazolamide tablets are available again from AA Pharma. The drug identification number or DIN is 00545015.
Please note that Acetazolam (Valeant Canada LP) is no longer available, this product has been discontinued. A notice of this drug discontinuation is posted on www.drugshortages.ca. The drug identification number or DIN is 00295019.
Two clobazam drugs are in shortage:
APO-clobazam (DIN 02244638) is on back-order. The company's estimated resupply date is July 5, 2015.
PMS-clobazam (DIN 02244474) is not available. Resupply date is unknown.
The clobazam products that are not in shortage are: Teva-clobazam, Frisium and Clobazam-10 (available in Quebec)
People may experience difficulty locating PMS-clobazam at pharmacies. There is still some APO-Clobazam in the drug supply chain but it isn't known if there is enough to last until the next batch is released. If your drug store has run out of APO-clobazam the pharmacist may be able to find some from a different supplier or by contacting another drug store. We expect some people who currently take APO-clobazam or PMS-clobazam may receive an alternate brand if they need their clobazam prescription refilled in the next few weeks.
Please contact your local pharmacy to inquire about this drug shortage.
March 5th, 2013
Pfizer has reported that they are experiencing a shortage of Neurontin tablets (600 mg) which is expected to be resolved by March 15, 2013.
Epilepsy Ontario contacted Pfizer's customer service department and learned that all other strengths of Neurontin are available: 100 mg, 300 mg and 400 mg capsules, and 800 mg tablets.
This temporary shortage appears to be restricted to the 600 mg Neurontin tablets only. There is no indication that any other brands or dosages of gabapentin are affected. If you take Neurontin 600 mg tablets, contact your pharmacist for more information and to ask whether they have the medication in stock.
For additional information visit the
Canadian Drug Shortages Database.
Pfizer Canada Inc., Customer Service Department 1-888-275-9938
(Adapted from Epilepsy Ontario - Voices of Epilepsy)