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Canadian birth control recall — for placebos instead of real pills

Here’s one of those screw-ups whose impact would be significantly dampened if it wasn’t covered up by the drug corps responsible. Users of Alysena-28, by Canadian drug company Apotex, should check their pills’ batch number.

Apotex says one batch of the Alysena-28 may contain two weeks of placebo sugar pills instead of one, adding the error can reduce the effectiveness of the pills and raises the possibility of unplanned pregnancy.

The company informed wholesalers and retailers Friday, but did not inform women who are taking the pill.

The code on the recalled packages is LF01899A. The bad packages were distributed in all provinces except Saskatchewan and Alberta.

Emphasis mine.

Emily Costello, a university student in Halifax who uses the drug, said she panicked when she heard about the recall.
[...]
“It’s unbelievable to me that they didn’t do a public recall right away,” she said. “What were the reasons that they had to go through the retail first?”

In Halifax, volunteers at the the Sexual Health Centre spent the afternoon contacting 120 clients who might be taking the recalled drug.

What I don’t get about this is, Alysena is — according to every photo I can find immediately, and even the one on the CBC article linked — supposed to be color-coded pink for the ones with hormones, and white for the placebo pills. In searching for the “-28″ variety specifically, though, I happened upon one picture of a totally different type of birth control pill, which has two weeks of pink and two weeks of white, which got me to thinking. This visual difference should hopefully have been a clue to any regular users, if not newbies who actually read the insert that came with their first pack. This should hopefully have caused enough ruckus when people actually asked about it.

So, I have to wonder — did the screw-up actually involve two rows of white pills? If it did, causing questions, and the company did not act accordingly — remember, Health Canada first issued a voluntary recall then upgraded it shortly thereafter, but Apotex was damningly silent, save for a statement that the drug might be “less effective” after missing seven days in a row — then this is a gross breach of public trust. And if it’s a row of pink placebos, how did they even get made? Neither question’s answers are immediately forthcoming, and the way the company has reacted is less than reassuring. An error can be forgiven. A cover-up, not so much.

Update: From Stacy McGill in the comments:

I have a pack of the recalled ones that I didn’t use yet, and there are three rows of pink pills and one of white- just like every pack.

So that answers that. As long as this is the case for all the pills, the placebo pills are not visually different, meaning something went very wrong in the manufacturing. And also meaning, because there was no visual cue to mitigate the problem, this could affect a very large number of people.

(Also: before any lookie-loos wander by, wondering what makes this so important, remember that the right to choose when you get pregnant is a human right and without that right, women don’t have the same level of bodily autonomy as men. It’s part of why women are societally disadvantaged thanks to the patriarchal system our culture is so damned steeped in today.)

Comments

  1. Stacy McGill says

    The picture of pills that have 2 rows of white are not alysena brand pills. I have a pack of the recalled ones that I didn’t use yet, and there are three rows of pink pills and one of white- just like every pack.

  2. Robert B. says

    Producing the chemicals and dying them white or pink might happen in two different places in the factory. It seems possible that a batch of placebos might get sent to the pink-dye machine and from there continue in their mistaken categorization. But in that case, I would expect to find pink placebos mixed in with pink medicine at random, not a neat row of extra sugar pills. I’m trying to imagine a production process that would keep pills thought to be identical sorted from each other so that a mistake could be so precisely located, and nothing comes to mind… unless the pills are laid out in rows for packaging and then dyed, which would be bizarre.

  3. hemlock says

    They don’t dye the chemicals, what happens in my understanding is that you have an inert filler (which may be dyed) and then the active ingredient is added, mixed in and then pressed into pills. This could mean that while it could have happened a double lot of placebo pills went into packing, there are other possibilities like a mix up with the filler being used on the wrong line or a step was missed in the manufacturing steps meaning the active ingredient wasn’t mixed in with some pills. Generally they test random selections on a batch for quality control reasons, it may not have been initially obvious that there was a double lot of placebo pills in there. I’m not sure about the picture, it may be a stock picture of generic pills rather than the actual pill used.

    This is a really poor recall, the public as well as prescribers and dispensers should have been contacted so they could warn those on that particular pill to check the batch and return them for a new batch if it was the one affected (as well as any other appropriate measures required). Telling wholesalers and retailers does effectively nothing other than they can check stock on hand, especially if it’s been sent off months ago. It shouldn’t ever happen, and especially with something that is so critical and could lead to some very significant effects on a person’s life.

  4. mithrandir says

    It’s a sad commentary on the discourse that one might even think they needed to explain why this is important. In a sane world, any case of a defective medication being distributed to customers, and said customers not giving adequate notification when the defect was discovered, would self-evidently be a big deal – no matter what kind of medication it was.

    It baffles me that there might be anyone who would say “who cares, it’s just birth control”, and it saddens me that I can nevertheless believe there might be.

  5. katybe says

    I know the ads on here are weird anyway, but how on earth did the company setting keywords decide that if you’re reading an article about birth control, you also want to buy their “natural” menopause medication? Surely that’s not their target market?

  6. says

    Google remnant ads are weird — and they don’t always keyword-search based only on the page, they also take into account your own Google search history, your region, recent click-throughs, and other factors that Google has in its index.

    That said, I’m getting mostly cloud storage ads for Linux-based services. Even on other pages on the site having to do with other things. Almost Diamonds almost always gets me cubic zirconium ads though. :D

  7. says

    diane: Let’s not go conspiracy theory. I’m sure the company wants to operate profitably and not incur the costs of millions upon millions of dollars of liability claims.

    Never attribute to malice that which can be explained by incompetence.

  8. George J says

    @Kevin

    Except a simple Google search provides several FDA warnings to Apotex dating back to at least 2009 and in fact, they had been banned until recently from importing their generic medicines into the United States due to the failure to address those violations.

    So no, this company really doesn’t seem to have their act together when it comes to good manufacturing practices. At least in the opinion of the FDA. Who knows what the Canadian government thinks about them considering they are billed as the “largest supplier of medicines in Canada”.

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