Diane-35: Family whose daughter died after taking drug sues Shoppers Drug Mart The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.

Diane-35: Family whose daughter died after taking drug sues Shoppers Drug Mart
The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.



The family of eighteen-year-old Marit McKenzie, who died of a massive bilateral pulmonary embolism, is suing Shoppers Drug Mart for failing to warn of dangerous side effects of the drug Diane-35. McKenzie had been taking the drug for a mild acne condition for 11 months when she died.
By: Diana Zlomislic News reporter,


The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.


While other major pharmacies highlight the “very serious” and “sometimes fatal” risk of blood clotting connected with Diane-35 on the drug information sheets they supply to patients, Shoppers does not. A senior pharmacist hired by Shoppers to produce an electronic inventory of drug risks told the Toronto Star the company didn’t want to “frighten” consumers by including rare but serious side effects on its printouts for the public.


Shoppers patrons who take Diane-35 are instead advised to watch out for headaches, tender breasts, menstrual pain, swelling and a lowered sex drive.
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The family of Marit McKenzie, 18, a first-year university of Calgary student who died after suffering four cardiac arrests, a massive pulmonary embolism and brain hemorrhaging in late January, is seeking $85,000 in damages and legal costs. That is the maximum allowable in Alberta for such a loss.


“Shoppers was negligent in providing sufficient information to Marit regarding the warnings and risks associated with taking Diane-35,” states the claim, which was filed last week in a Calgary court. It also argues that Shoppers should have told McKenzie to stop using the drug three to four months after her acne cleared, a protocol recommended by the manufacturer to reduce the likelihood of side effects.


The McKenzie family’s legal claim states that Shoppers has a “duty to provide accurate, current and pertinent information” about the risks and warnings associated with the medications its pharmacists dispense and that the company did not fulfil this duty.


The allegations have not been proven in court.


Lana Gogas, a spokeswoman for Shoppers, said the company could not comment on the legal claim. Shoppers has not yet filed a statement of defence.


The drug information Shoppers distributes to its pharmacy customers is supplied by a Quebec company that has held the contract for more than 10 years.


“We restrict to a maximum of six side effects on all drugs,” explains Raymond Chevalier, the president of Les Consultants Vigilance Santé, which is based just outside of Montreal. The information is poured into an electronic database that is accessed by Shoppers stores across the country.


“We select the most prevalent, the ones most likely to occur, the ones the patient can identify . . . The purpose here is not to frighten anyone,” said Chevalier, who is also a pharmacist.


Bruce McKenzie, an architect in Calgary, says he would rather be afraid if it meant saving his daughter Marit’s life.


In the weeks before her death in January, Marit McKenzie had grown increasingly anxious about her physical condition. She was constantly tired, easily winded and found it difficult to concentrate. After her death, Bruce McKenzie and his wife, Susan, discovered that these symptoms were outlined on the patient information sheets for Diane-35 that were handed out at other pharmacies, including Safeway and Calgary Co-Op. The Toronto Star also found this information on the drug information sheets distributed by Walmart, Loblaw and Rexall pharmacies.


1 drug, 3 stories: What pharmacies are telling patients about Diane-35


Shoppers Drug Mart (PDF)


Walmart (PDF)


Loblaw (PDF)


The week before her death, Marit McKenzie complained to her family doctor, but her condition was chalked up to school-related stress. Routine blood work was ordered but it came back normal, the Star learned after interviewing Dr. Dubravka Rakic, who prescribed Diane-35 to McKenzie.


Several days later, after suffering four cardiac arrests, a pulmonary embolism and bleeding in the brain, McKenzie was pronounced dead in hospital on Jan. 28, 2013.


She became the 13th Canadian woman, and the eighth younger than 21, whose death has been unofficially linked to Diane-35 in Health Canada’s adverse reaction database. Since the majority of her organs were donated immediately, there was no formal autopsy. A hospital pharmacist filed the adverse drug reaction report listing Diane-35 as the suspect cause of her death. McKenzie had been taking it for just over a year.


The drug, which is approved by Health Canada as a short-term treatment for severe and otherwise untreatable acne, has been the subject of three federal warnings since 2002 that addressed the elevated clotting risk. The warnings also emphasized that Diane-35 should not be used as an oral contraceptive. Health Canada is now trying torein in off-label use for the hormone-based pill with help from the manufacturer, Bayer, which has launched an education campaign for doctors.


Shoppers, though, does not appear to be helping on that front either.


Its information sheet for Diane-35 calls the drug a “hormone-based contraceptive.”


“I didn’t notice that myself,” Chevalier told the Star by phone from Repentigny, Que. “We’ll recheck that.”


Dr. Barbara Mintzes, a drug researcher based in British Columbia who has investigated the off-label use of Diane-35, worries that the additional drug information provided by pharmacies may create a false sense of security.


Consumers may reasonably assume the pharmacy’s patient information leaflets, which are often written in easy-to-understand language, is a “Cole’s Notes” version of the dense product monographs supplied by manufacturers.


Gogas of Shoppers says the sheets “are designed to provide patient-friendly information in order to educate the patient on the medication they are taking and help them manage their condition.” They “are not an alternative to a product monograph.”


“We’re not replacing the discussion that a doctor should have had with his patient before prescribing this drug, covering the side effects and risks and contraindications,” Chevalier says.


Rakic told the Toronto Star she was unaware the federal government had issued any advisories about Diane-35 when she prescribed it for McKenzie.


Nearly 500,000 prescriptions were written in Canada for Diane-35 or one of its two generics last year, according to IMS Brogan data supplied by Health Canada.


The relatively new practice among pharmacies to supply additional printed information to consumers is not mandated by any professional group.


Shoppers was one of the first retailers to provide its customers with drug information sheets. The practice dates back to the company’s launch of HealthWATCH in the late 1990s.


“There’s nothing from the college requiring they do this,” says Lori DeCou, spokeswoman for the Ontario College of Pharmacists.


“There is a standard practice to which we hold pharmacists accountable, which has to do with counselling,” she says. “A pharmacist is required to ensure their patient understands the medication they’re being prescribed.”