Editor's note: A earlier version of this article incorrectly described Apotex as the manufacturer of Alysena birth control pills. The manufacturer is Laboratorios Leon Farma of Spain. Apotex is the distributor.
Standing in her bathroom on Monday night, reading the fine print on her package of birth-control pills, Jacqueline Belo felt the panic many women will recognize: the queasy worry that you might be pregnant when you don’t want to be. Belo, a hairdresser who lives in Burlington, Ont., had just heard about the recall of Alysena pills from a certain lot number – and hers matched. “I thought my heart was going to stop, to be honest,” she says. “My life just flashed before my eyes.”
Belo, 30, doesn’t know if she ever wants kids, but both she and her husband of three years know that the time isn’t right. “I am definitely not ready to have kids,” she says. “Obviously, I have been taking the precautions for a reason.” And she’s not the type to miss a pill by accident; “I take them the same time every day. I don’t fool around with it.”
But this wasn’t Belo’s mistake: On Monday, Health Canada upgraded the recall of a lot of 50,000 packages of Alysena 28-day birth control pills that arrived on drugstore shelves in mid-December. The recall was prompted when an Ontario customer returned a package that included two weeks of white placebo pills. The blister pack typically includes three weeks of pink pills, which contain the active ingredients of the drug, and one week of white sugar pills, which are included to help patients remember to continue taking them.
There may be questions, however, as to why word of the problem took more than three days to reach many patients.
Late last Friday afternoon, a voluntary recall for lot number LF01899A of Alysena 28 was announced. This batch had been distributed to retailers in British Columbia, Ontario, Quebec and the Atlantic provinces. But Apotex, the drug’s distributor, decided, “based on their own assessment,” to issue a Type 2 recall, which requires drugstores to remove the product from their stock (but not alert patients), according to a Health Canada statement.
On Monday morning, Health Canada raised the level of the recall out of concern for women who had been advised not to get pregnant for medical reasons or who might be using drugs that “could be harmful to a developing fetus.” The updated recall advises women to check their packages and contact their doctors for advice, as well as to use an alternative birth control in the meantime.
The decision to delay the more serious recall is upsetting to women such as Belo, who would consider an unwanted pregnancy a serious health consequence. “If I didn’t have the TV on last night, I wouldn’t have known to check.”
As the recall was upgraded, pharmacists and doctors have begun calling patients who may have taken home a box from the lot number in question. London Drug, based in Vancouver, had already taken the step on Friday, tracking down 21 stores where the problem batch had been stocked, and calling every customer who might have received one. (Every patient under 18 was contacted in confidence through their doctor.)
“It was a judgment call,” said John Tse, the chain’s vice-president of pharmacy. “You find one box – is there another? That’s the unknown we can’t answer.”
In addition, London Drugs has offered every affected customer a free pregnancy test or morning-after pill; a small number of women have asked for them.
Apotex says it’s easy to know if you have a improperly packaged dose: Customers will have two rows of white pills in their blister pack. The pink pills, containing the active ingredient, work as usual, said Elie Betito, Apotex’s director of public and government affairs.
Still, the company, which has since distributed seven more lots of product manufactured specifically for Canada from a factory in Europe, can’t yet say how the error happened or how many packages were affected. As of Tuesday morning, it said it had learned of only one. “We are taking full responsibility,” Betito said, though he also suggested that most patients would probably notice the error when they opened the pack.
Since the batch went on shelves in December, however, some women may already have used them, creating a potential liability for Apotex: “We have had calls saying, ‘My wife is pregnant and it’s your fault,’ but they don’t have the package any more,” Betito said.
Belo was lucky she had her package: It had three rows of pink pills.
“I can breathe a little easier,” she says. “I will definitely still go and take a test.”
Have you been affected by the recall? E-mail firstname.lastname@example.org