Both Alysena 21 and Alysena 28 birth control packs may contain chipped pills, Health Canada advises.
Last month, Apotex Inc. voluntarily recalled a lot of Alysena 28 birth control pill (lot LF10133A) after the company received complaints about chipped pink pills.
Alysena 28 contains 21 active pills and seven inactive pills without hormones. The other product includes 21 active pills.
Health Canada and the Society of Obstetricians and Gynecologists of Canada have previously said that active pills that are chipped may contain less of the active drug ingredients, which may reduce Alysena’s effectiveness in preventing pregnancy.
A spokesman for Apotex said Thursday that the initial recall last month was done out of an abundance of caution.
“We voluntarily recalled the product initially just out of an abundance of caution before we had all the scientific data,” said Jordan Berman, global director of corporate communications with Apotex. “We now have scientific data from both published studies and internal testing by the manufacturer, which demonstrate that taking pink pills that have a small chip at the edge will not reduce the product’s overall effectiveness in preventing pregnancy.”
Health Canada has also reviewed the data, Berman said.
Both prescription drugs are used to prevent pregnancy. Alysena is also prescribed to treat a type of moderate acne in those who are age 14 and older, the company says.
Consumers are advised:
- Do not consume a pill if it looks unusual (for example, it is chipped, has jagged edges or is broken). Examine both sides of each pill thoroughly before taking it. It may not be immediately obvious from looking at the blister package that there is a problem with the pills, since the underside of the pill cannot be seen while in the blister pack.
- If you have a package with an unusual looking pill, return it to your pharmacy for a replacement package.
- Do not stop taking your birth control pills as this may result in pregnancy. Talk to a health-care professional if you have questions or concerns about your birth control product, including about missed doses and alternatives.
- Report adverse events or complaints regarding health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
Health Canada said Apotex has put in place measures to address the manufacturing issue and the company is conducting more visual checks of the products before release.
Apotex said the product is manufactured by a third party in Europe.