UPDATED: Shortage of seizure drug leaves Canadian patients frightened

Empty pill bottle
(Epilepsy Ontario)

Epilepsy patients in Canada are searching for supplies of seizure drug clobazam after interruptions at Canada’s largest drug company and another supplier led to shortages. While Canada’s Apotex says wholesalers are again getting the product, support groups have alerted patients that some pharmacies are still short of the drug.

One Canadian mother told The Star that she finally secured a month’s supply from a hospital after three pharmacies in her area were unable to help her. Her severely autistic son suffers from a variety of seizures, including one she said is potentially fatal.

“I’m literally terrified,” Mistie Delorey told the newspaper.

With tens of thousands of Canadians turning to the drug to control seizures, many are now frantic to get their hands on it as supplies. The situation has gotten to severe in recent weeks, that Health Canada held a teleconference with epilepsy groups to discuss the shortage.

In a statement Tuesday, the regulator said, "Health Canada recognizes the seriousness of this shortage and has been actively working to gather information about the supply situation, has coordinated information-sharing among stakeholders, and has engaged the manufacturers to understand their strategy for resolving the shortage."

Canada drug giant Apotex supplies an estimated 70% to 80% of the market, with Lundbeck’s Frisium brand, which also was in short supply, and a Teva generic filling the rest of the demand. Suzanne Nurse, chair of the Canadian Epilepsy Alliance Drug Shortage Committee, told The Star that there have been three significant shortages in the last three years, including a disruption in Apotex supply a year ago. After a month, the problem seemed to be resolved but she said at year-end Apotex announced supplies were thin and that the situation was not expected to be resolved until this summer.

Apotex exec Eli Betito told The Star that the company in late June released some product and that the company had gotten a new consignment of API and was manufacturing more of the drug.

Apotex, which has had its manufacturing challenges in recent years. Both the FDA and Health Canada in 2014 banned some drugs and APIs from two Apotex plants in India over data integrity issues and the FDA followed up with a warning letter for one of the facilities. Health Canada lifted its ban last year when it said Apotex showed progress of remediation.

An Apotex spokesman said in an email that the supply glitch was unrelated "to the remediation at the Indian facilities, but rather to a disruption in the supply of raw material for this particular product."

While the situation looks to be getting resolved, Nurse of the Epilepsy Alliance explained to The Star that since the shortage has been ongoing for months “it’s going to take a period of time to get back to regular supply levels where people won’t have any trouble getting the drug.” Until then, she said the situation will be scary for patients, many of whom have been seizure-free for years only because of clobazam. “It’s the only drug that’s ever worked for some people.”

- read The Star story 
- here’s the notice from Epilepsy Ontario

Related Articles:
Apotex sees Health Canada lift ban on two India plants 
FDA warning letter scorches a second Apotex plant in India