Advisory - Chipped pills in additional packages of Alysena 21 and 28 birth control pills

OTTAWA, March 8, 2018 /CNW/ -

Issue

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Alysena 21 blister pack - Alysena 28 blister pack (CNW Group/Health Canada)

Further to a recent advisory about the recall of one lot of Alysena 28 birth control pills because of chipped pills, Health Canada is informing Canadians that all lots of both Alysena 21 and Alysena 28 may have chipped pills. Health Canada is reminding women to always check their pills carefully before taking them.

Alysena 21 and Alysena 28 are prescription drugs used to prevent pregnancy as well as to treat acne (in women 14 or more years of age). Alysena 21 contains 21 "active" pink pills, while Alysena 28 contains 21 "active" pink pills and 7 "inactive" white pills.

Who is affected

• Women who are currently taking Alysena 21 or 28
• Health professionals who dispense the product

Affected product

• Alysena 21 (DIN 02387875) and Alysena 28 (DIN 02387883)

What consumers should do

• Check your pills before and after taking them out of the blister package. Do not consume a pink 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 find a chipped pink pill, take the next unchipped pink pill. Do not miss a dose as this may result in pregnancy. Return any packages with chipped pills to your pharmacy for a replacement package. Packages with no chipped pills do not need to be returned.
• If you have no unchipped pink pills left, then return the package to your pharmacy as soon as possible for a replacement package. Use a non-hormonal method of birth control (such as condoms, spermicidal foam or gel) until you can obtain a replacement package, and contact your health care provider for medical advice.
• 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 to health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.

Additional information for pharmacists:

• Check each blister pack of Alysena 21 and Alysena 28 before dispensing it to make sure the pills look as they should.
• Report any unusual pills to the company (Apotex Inc.) and to Health Canada.

What Health Canada is doing
Health Canada will continue to monitor this issue and will take necessary action, including informing Canadians as appropriate.

Background
Apotex Inc. voluntarily recalled one lot of Alysena 28 (lot LF10133A) on February 9^th, 2018 as a precaution while it determined the scope and nature of the issue.

Apotex Inc. has put in place measures to address the manufacturing issue and is conducting additional visual inspections of the product before release. Based on a thorough assessment of all available information, Health Canada considers these measures, along with patients visually checking the pills and not taking pink pills that are chipped (and not missing a dose), adequate to address the issue at this time.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone]; Public Enquiries: [phone], 1-866 225-0709