Are birth-control pills held to a lower standard than other prescription medications?
The facts surrounding three recent recalls of oral contraceptives suggest the answer is yes.
In April, Apotex announced a recall of Alysena-28 after a consumer found an extra placebo in her package of pills. Last month, Mylan Pharmaceuticals announced a recall of Freya-28 because of the same packaging error. About a week later, Mylan recalled Esme-28 because it was made in the same plant as Freya and the company couldn't rule out the possibility it was affected by the problem.
Women's health advocates say that not only has this recent string of recalls shaken their confidence in the quality and safety of oral contraceptives available in Canada, but that it also highlights a lack of understanding, or appreciation, for why women need access to reliable contraception. Some say the muted response to the recalls is part of a wider societal trend of ignoring the importance of women's health issues, particularly as they relate to reproductive rights, and characterizing critical matters like contraception as "lifestyle" issues.
"It becomes unsettling," said Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada. "This is what women have never had to worry about in the past."
Although the recalls have sparked worry among many women and medical professionals across the country, there has been a lacklustre response from drug manufacturers and the federal government, said Blake. Pharmacists and doctors were not officially notified of the birth-control problem by federal authorities and there have been significant delays informing the public of at least one of the recalls.
But what many can't understand is how faulty birth-control pills can be characterized as a minor inconvenience.
Health Canada issued a "Type II" hazard classification for the Alysena-28 recall, which is used to signify a non-urgent problem that may cause "temporary adverse health consequences or where the probability of a serious adverse health consequence is remote." A Health Canada spokeswoman said pregnancy isn't considered a health risk, hence the lack of urgency. The department later added a "Type I" classification to the recall, but only because certain women, such as those who have been medically advised against pregnancy, could be harmed. Health Canada did not include hazard classifications for the two most recent birth-control recalls, but the fact that no warning letters were sent to doctors or pharmacists indicates they were classified as Type II.
So what does Health Canada consider to be an urgent Type I recall?
Here are two recent examples: Earlier this month, over-the-counter heartburn tablets were recalled because of a misprint on the packaging. Then there was the urgent recall of Ibuprofen capsules sold without a child-resistant cap.
While missing a birth-control pill may not seem as harmful as missing a chemotherapy appointment or getting the wrong heart medication, it can actually be a very serious matter. Birth-control pills require precision, attentiveness and diligence. In order to be effective, active hormonal birth-control pills must be taken every day for 21 days. That is followed by seven days in which no pill is taken, which is when a woman would expect her period. Some pill packages come with seven placebo pills that women take during that week to keep them in the habit and help them remember to take their daily pill.
If a woman misses one active pill in a month, doesn't take her pills at the same time every day or even starts a pill pack on the wrong day, her chance of unintended pregnancy goes up. Which helps explain why so many women were alarmed to learn their birth-control pills were being recalled because they might contain an extra placebo.
"It's absolutely critical that women have the correct number of pills to take on the correct days of each month or they may as well not be taking that particular pill," Blake said.
Blake said she is disturbed by the fact that no one from the affected drug companies has reached out to her organization to discuss the recall or explain the steps they are taking to fix the problem. The SOGC is also troubled by the fact that it took five days to inform the public about the Alysena-28 recall and that no official warning was ever sent to doctors or pharmacists. Those letters are typically sent when a drug or medical device is recalled so that doctors and pharmacists can alert affected patients.
The Ontario Pharmacists' Association said it shares the concerns over disclosure.
"Certainly it's concerning," said CEO Dennis Darby. "I think improvements could have been made."
Canadian women don't even have complete access to a wide range of birth-control options, which is a critical accessibility issue, points out Dr. Sheila Dunn, a family physician at Women's College Hospital in Toronto and an expert in reproductive and sexual health.
For instance, the contraceptive implant – a small flexible tube that's placed under the skin in the upper arm – isn't available in Canada, despite the fact that it's proven to be more effective than the birth-control pill and other contraceptive methods. It's also a viable alternative for women who can't take oral contraceptives for health reasons, Dunn said.
"To not have access to that as a choice, for me, is a problem," Dunn said.
In each of the recent recall cases, the pills were manufactured by a third-party company overseas. Alysena-28 was made by Laboratorios Leon Farma in Spain, while Freya and Esme were made by Famy Care, based in India.
Dr. Wendy Norman, assistant professor in the department of family practice at the University of British Columbia, said the recall is a good opportunity for women to be reminded that they should take charge of their health.
Women should inspect their birth-control pills before they take them and speak up if there is a problem, she said. Norman added that despite the recalls, she sees no reason to question the safety and reliability of other contraceptives on the market.