Birth-control recall: Experts still unsatisfied with Health Canada despite investigation into delays

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Anger over a bungled birth control pill recall is continuing to grow, despite assurances the federal health minister is launching an investigation into the matter.

The Globe and Mail reported Thursday that Health Minister Leona Aglukkaq has ordered Health Canada to investigate why it took so long to inform women taking Alysena their birth control pills were under recall.

Last Wednesday, Apotex Inc. learned there may be serious problems with one lot of its generic birth control pill Alysena after a customer found her pill package contained an extra week of sugar pills. One week of sugar pills is typically included in a 28-day pack to remind women to take the pills each day. An extra week of sugar pills puts women at risk of accidental pregnancy.

Apotex informed Health Canada of the problem last Thursday. However, Health Canada and Apotex failed to inform the general public of the problem until last Monday, nearly a week after the problem was first identified. A Health Canada spokeswoman explained that an urgent recall was not issued immediately because the problem with the pill was not considered life-or-death. Instead, the department and Apotex issued a "Class II" recall, reserved for products that may cause temporary health issues, or where the probability of a serious health impact is low.

In other words, risk of accidental pregnancy was not deemed serious enough to trigger an urgent product recall.

The department upgraded the recall on Monday to a Class I recall after realizing some women who shouldn't become pregnant for medical reasons could be affected.

Health Canada spokeswoman Blossom Leung said in an e-mail the recall assessment takes health impacts into account, not "lifestyle impacts" such as unplanned pregnancy, which is why the urgent product recall was only issued Monday.

Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada, said the response to the recall is unacceptable and that the organization was "dumbfounded" to learn women weren't informed of the problem with Alysena for days.

"The delay in issuing a Class I recall is inexplicable," Blake said in an e-mail Friday. "Women had protective actions they could have taken immediately, had they known."

In addition to the timing, the recall also raises important questions about whether Health Canada's quality-control processes are adequate, particularly when it comes to drugs manufactured overseas.

Alysena is produced in Spain by Laboratorios Leon Farma and distributed in Canada by Apotex. There have been growing concerns over the quality and safety of drugs produced overseas and many health advocates question whether Health Canada is doing enough to ensure overseas plants are following good manufacturing practices.

Blake said the Alysena recall represents "an unacceptable lapse in quality control" and that Canadians need answers as to whether the drug supply is safe.

Brian Stowe, an independent pharmacist and owner of the Prescription Shop on the campus of Carleton University in Ottawa, said the recall is the latest in a string of problems involving generic birth control pills. The generic brands of birth control pills are often facing shortages, meaning patients are forced to constantly switch brands, which can lead to unwanted side effects, such as bleeding. Stowe said these problems are exacerbated by the drive to lower the cost of generic drug prices in Canada, because it encourages drug firms to sell their product in more lucrative markets.