Alert: divalproex sodium (Epival) shortages – revised July 20

February 11, 2016

Last update: July 20, 2016

There have been serious shortages of divalproex sodium (Epival) in Canada this year. The situation has not been fully resolved yet.

For information about valproic acid capsules click here

Current shortages:

Apo-divalproex 125mg  – last shipment June 9; next replenishment July 31 July 30
Apo-divalproex 250mg  – last shipment June 29; next replenishment July 11 Sept 1
Apo-divalproex 500mg  – last shipment June 29; next replenishment July 11 July 31

Teva-divalproex 125mg  – last shipment June 6; next replenishment October 14
Teva-divalproex 250mg  – last shipment June 6; next replenishment July 22
Teva-divalproex 500mg  – last shipment June 6; next replenishment July 22

Epival 125 mg – next replenishment October 7 November 25
Epival 250 mg – next replenishment August 19
Epival 500 mg – last shipment May 27; next replenishment August 12

For any updates or changes visit drugshortages.ca

Overview of the situation for people living with epilepsy:

Any shortage of an antiseizure drug is a very serious concern. This particular medication is a widely used antiseizure drug and is also used to treat other chronic diseases, such as bipolar disorder.

The situation could vary from one pharmacy to another. During a drug shortage, the best source of information about the supply of your medication is your pharmacist.

We advise people who take divalproex sodium (Epival) to contact their pharmacist and ask about the supply of their medication.

Contact your healthcare provider if the pharmacist can not find any supply of divalproex sodium. They can discuss the situation with you and provide medical advice. 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.

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 than the prescribed amount, or suddenly stopping an antiseizure drug is dangerous. This can lead to breakthrough seizures, more prolonged seizures or life-threatening events.

If you need any help during this drug shortage, please contact Epilepsy Ontario by calling 1-800-463-1119 or email [email protected].

Clinical management information for healthcare providers

The Canadian League Against Epilepsy has provided suggestions for healthcare providers. This information is for situations when there is no divalproex sodium available. With the improvements in the supply of this drug it should no longer be necessary for people to be switched to a different medication although there are continued shortages and people may experience difficulty finding some specific brands of divalproex or certain tablet strengths.

Suggestions for patient management during the divalproex shortage:
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Why has this drug been in shortage?

The shortage situation began over a year ago. Apotex Inc. went into shortage on the 250 mg and 500 mg strength Apo-Divalproex tablets in the spring of 2015 due to a manufacturing issue. Last fall, the 125 mg Apo-Divalproex tablets also became unavailable.

Apotex Inc. was the major supplier of divalproex to the Canadian market. The prolonged shortage of all strengths of their divalproex tablets resulted in a significant shortfall. As a result, all forms of divalproex, generic and brand, became depleted.

Health Canada worked with the manufacturers and other stakeholders during the winter/spring to address this serious situation.

Previous Updates – March 2016

Click here to read a letter from Deirdre Floyd, President of the Canadian Epilepsy Alliance, to member epilepsy associations across Canada. Epilepsy Ontario is a member of this national organization.

Health Canada shared the following statement on March 15:

“We recognize the seriousness of this shortage and the challenges it presents to patients and their health practitioners who rely on access to divalproex to stabilize their condition.  We are working in partnership with all relevant stakeholders – including drug manufacturers, wholesalers, retailers, provincial and territorial governments and stakeholder organizations like the Canadian Epilepsy Alliance to coordinate an effective solution.” ~ Officials from Health Canada's Health Products and Food Branch

Responses from Pharmaceutical Companies – March 2016

At the present time a written response has been provided by one of the pharmaceutical companies that markets divalproex sodium in Canada, Teva Canada Ltd.

Click here to read Teva’s detailed communication regarding this drug shortage and their response, including upcoming resupply dates, tablet strengths and amounts of Teva-Divalproex.

Initial alerts and notices about divalproex sodium – December 2015

Click on the following link for more info: Drug Shortage FAQ’s