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By Kathy Tomlinson , CBC News
Posted: Oct 01, 2012 5:08 AM ET
Health Canada, Shoppers Drug Mart failed to flag Cipralex’s known risks
An Ontario man whose mother died from a heart attack after taking a popular anti-depressant believes she would still be alive if she’d been warned about the drug’s known dangers.
“She deserved better,” said Mike Schoger, an engineer from the Chatham area, whose 75-year old mother Trudy died in December, just hours after taking her first dose of Cipralex [escitalopram].
“Health Canada knew there were issues for months [before fully warning the public],” said Schoger.
Trudy Schoger was on a diuretic, but otherwise healthy, when she was prescribed Cipralex for depression. The day she died, her son found her writhing in pain on her bed.
“She took the first dose and 45 minutes later she started getting pain in her shoulders and neck and chest,” said Schoger. Hours later, his mother lay dead in hospital and he was in shock.
“You could say my mom was one of my best friends,” said Shoger. “The last thing I would have expected is for something like this to happen.”
The woman had no previous heart troubles. Her death was blamed on natural causes, but her son says he doesn’t buy that.
Cipralex is known to potentially cause heart attacks in patients who are taking diuretics, or who have electrolyte imbalances, which are often caused by taking diuretics. Diuretics increase the excretion of water from bodies. Schoger’s blood work showed her sodium levels were dangerously low when she took Cipralex.
“My mom would have not touched that drug had she known. Guaranteed,” said Schoger.
Problems known earlier
The maker of Cipralex, Lundbeck, had acknowledged the risk to regulators in 2011.
In November and December, warnings about Cipralex and electrolyte imbalances were sent out to physicians and the public in the U.K. and Ireland.
In January, Health Canada said health-care professionals and the public were notified that the agency was looking “to determine if there was a need to include further information for Cipralex,” because the same dangers had been found with a similar drug called Celexa.
However, the agency failed to fully warn Canadians of the risk — of mixing diuretics with the anti-depressant — until May.
“Use of Cipralex is discouraged in patients who are also taking drugs … that decrease electrolyte levels in the body … drugs that may affect electrolyte levels include: diuretics (water pills),” the May warning reads.
That was five months after the public in the U.K. was warned about Cipralex and electrolyte levels, and too late for Trudy Schoger.
“So am I to understand that the physiological makeup of a U.K. citizen is different than that of a Canadian?” asks her son. “Someone has to be held to account.”
“Heath Canada takes a number of sources of information into account while conducting a comprehensive review, including consultation with additional expertise,” spokesperson Sean Upton responded, after being asked why Canadians weren’t warned at the same time as Britons.
Shoppers info outdated
Schoger’s mother had her prescription filled at a Shoppers Drug Mart in Chatham. The information sheet on Cipralex she got with her prescription said nothing about any heart-related risks.
“As far as I’m concerned, there should be a skull and crossbones on the packaging for this medication,” said Schoger.
He recently picked up another Cipralex info sheet from the same Shoppers location and said he was shocked to find it is exactly the same as the one his mom was given in December, despite the serious nature of the Health Canada bulletin issued in the spring.
“The whole system doesn’t work. You are on your own,” said Schoger.
The information comes from a private database Shoppers Drug Mart outlets draw from across Canada.
“You go to the pharmacy. You pick up your medication. ‘Oh, here’s the product information leaflet. By the way you can’t rely on it’. Maybe they should inform everyone of that,” said Schoger.
Go Public asked Shoppers Drug Mart several times why the information sheet on Cipralex has not been updated — and whether it will be now — given the dangers pointed out in the Health Canada warning. The company has not answered that question.
“The information that is provided to patients in conjunction with their prescription, along with pharmacist counselling is designed to be appropriate for the patient and therefore it does not discuss detailed clinical information,” wrote Shoppers spokesperson Tammy Smitham in an email.
Pharmacists want improvements
The Ontario Pharmacy Association admitted there is a huge delay from when drug warnings are issued to when they get in the pharmacy database for consumers.
“The assumption is that these information sheets are changed in real time when in fact it takes quite a long time for changes to be formally introduced into the software,” said Allen Malek, the association’s drug information specialist.
When asked why pharmacy information does not include a warning that is on Health Canada’s website, he said: “You are absolutely right, it is on the website. The assumption is also that the website is checked on a regular basis.”
Malek said it is up to the federal agency to initiate improvements.
“Ultimately the buck stops with Health Canada,” said Malek. “My heart does go out to [Schoger] and his entire family … we need to all do a much better job from the top down.”
Health Canada’s adverse drug reaction database shows nine reported cases of serious, heart-related adverse effects in Cipralex patients in the five-month delay between the U.K.’s public warning about the drug and diuretics and Health Canada’s.
Schoger’s case is included in that number along with a 25-year-old man who died from a heart attack in February. His death was reported to Health Canada by his physician. The data doesn’t show whether he had electrolyte imbalances as Schoger did.
A University of Victoria drug policy analyst called the system to inform Canadians about drug information “lame.” Alan Cassels also said Health Canada is ultimately responsible.
“This is something I have been railing against for 15 years,” he said. “People pay taxes. They expect Health Canada to keep the drug supply safe and the information to be properly communicated to consumers.”
Schoger says he has lost faith in the system since his mother’s death.
“Knowing that the whole system is broken, I will never take another prescription medication again as long as I live,” he said.