Many Canadian women may unknowingly be affected by a massive recall of birth control pills that could put them at risk for unplanned pregnancies.
Health Canada announced to the public on Monday that Alysena 28, a generic birth-control pill distributed by Apotex Inc., is being recalled because it may contain an extra week of placebo pills instead of the medication.
But women who thought they were taking Alesse, the brand-name version of the pill, may actually have been given Alysena by their pharmacist. It's a common practice known as "generic substitution," which allows pharmacists to dispense cheaper generic pills instead of the more expensive brand-name version.
"People who thought they were on Alesse might actually be on Alysena," said Dr. Jennifer Blake, chief executive officer of the Society of Obstetricians and Gynecologists of Canada.
Pharmacists are not required to tell patients when they are substituting a generic version and many women may not realize the difference because Alysena and Alesse have similar names, packaging and colours, Blake said. "It would say Alysena on [the package], but everything else would all look alike," she said.
Blake noted that the society was informed of this problem only on Tuesday, "which is itself a concern."
The recall is being described by Blake and other health experts as unprecedented. She said the organization is hearing from women who are concerned about the possibility they may have become pregnant. There are also concerns about the timing of the recall. Although Health Canada was informed of the problem last week and sent a recall notice to pharmacies and other retailers, a notice to the general public didn't go out until Monday.
Phil Emberley, director of pharmacy innovation at the Canadian Pharmacists Association, said it's unclear how many women prescribed Alesse may have been given Alysena instead. Pharmacists have been reaching out to affected patients to alert them of the recall, he said.
Some provinces, such as Ontario, as well as drug plans require pharmacists to distribute generic versions of drugs to patients when available. But if pharmacists do substitute generic versions of drugs, they should be telling patients and ensuring they understand, Emberley said. Some patients may prefer the brand name and may want to stay on it, even if they have to pay out-of-pocket, he said.
The Society of Obstetricians and Gynecologists of Canada maintains that generic birth-control pills should not be used to substitute for brand-name versions. In a 2008 statement, it noted that new generic versions of birth-control pills may not be as effective as the brand-name versions.
Options for Sexual Health, a non-profit organization based in Vancouver, says on its website that "there is not enough scientific evidence to support that any of the generic contraceptives are 'clinically equivalent' to the brand-name products."