The third nationwide recall of birth control pills in six months is causing unease among Canadian women and raising questions about the quality and safety of the foreign drug plants where the medications were produced.
The pills were recalled after some packs were found to contain an extra placebo instead of an active medication – a mistake that could cause unwanted pregnancies. The rash of problems in recent months, the fact these pills are new to the market, and unexplained delays in launching and communicating recalls are cause for growing concern, medical experts say. About 430,000 prescriptions of the three affected drugs had been dispensed to Canadian women as of June.
“This is extremely troubling,” said Jennifer Blake, chief executive of the Society of Obstetricians and Gynaecologists of Canada. “You do worry that perhaps corners have been cut and not enough attention has been paid to quality.”
Health Canada announced Thursday a recall of Esme-28, a generic brand of birth control pills distributed in Canada by Mylan Pharmaceuticals. The recall comes a week after Mylan issued a recall of Freya-28, another generic birth control pill, after a package was found to contain an extra placebo pill instead of an active pill. Although no problems with Esme pills have been identified, the two brands are produced in the same Indian plant. Health Canada said the company has been “unable to rule out the possibility” that it was also affected by the packaging error. No explanation has been offered as to why both pills were not removed from the market as soon as the problem with Freya was identified.
Last April, generic giant Apotex Inc. conducted a massive recall of Alysena birth control pills over the same placebo pill mix-up. It took several days for the public to be notified of the recall, and the federal health minister’s office is investigating the delay.
All three brands have been on the market for a matter of months. According to health-care tracker IMS Brogan, as of June, 2013, about 3,600 prescriptions had been dispensed for Esme in Canada; 6,200 for Freya; and 419,800 for Alysena.
Health Minister Rona Ambrose said in a statement Thursday that she is awaiting the results of the review and that the government “expects drug manufacturers and Health Canada to quickly inform Canadians” of any risky products.
The recalled oral contraceptives were all manufactured in foreign countries before being shipped to Canada. While that in itself isn’t cause for alarm, numerous medical and drug policy experts say that serious, systemic problems with drug production in some countries should be creating alarm over the integrity of drugs coming to Canada.
“We have certainly seen a number of high-profile quality problems in recent years,” said Allan Coukell, an expert on drug policy at the Pew Charitable Trusts, a Washington-based research and policy organization. “I think there is some reason to be concerned.”
A growing number of drugs and raw ingredients are coming from countries such as India and China, where production costs are cheaper. And while regulators, including Health Canada, require companies that produce medications sold in Canada to comply with rigorous safety and quality-control processes, the growing global scale of pharmaceutical production can make those rules difficult to enforce.
Inspections are also few and far between. Logistics and cost makes it difficult for Canadian or even U.S. officials to visit many foreign plants or conduct unannounced spot checks. Many foreign plants can produce quality products and are able to pass inspections, said Roger Bate, a scholar at the American Enterprise Institute, a think tank in Washington. The problem, he said, is some may decide to cut corners when no one is looking.
In an e-mail statement, a Mylan spokeswoman said the company has a “long-standing commitment to quality” and that it has been pushing the U.S. Food and Drug Administration for increased oversight of foreign manufacturing facilities.
But recent problems with major Indian drug manufacturers suggest there are nagging quality-control issues. In June, Ranbaxy Laboratories, one of the country’s biggest drug makers, pleaded guilty to making adulterated medications and was fined $500-million (U.S.). In July, Britain issued a massive recall of drugs made at India’s Wockhardt after identifying problems at a manufacturing plant.