Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

Starting date:
April 16, 2018
Posting date:
April 16, 2018
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-66510

Issue

In light of continuing complaints of quality issues involving certain prescription birth control pills, Health Canada is reminding women to check their packages of birth control pills. If you notice anything unusual in the package, such as missing or damaged pills, you should return the package to the pharmacy for replacement as soon as possible. Skipping a dose because the pill is missing, or taking a damaged (for example, chipped or fragmented) pill, may increase the risk of pregnancy because less active ingredient may be taken. It is important to get a replacement package as soon as possible to avoid missing any doses.

Products affected

Birth control packages that contain damaged pills, an empty slot where a pill should be, or multiple pills in a slot where there should be only a single pill.

What you should do

  • Return your package to the pharmacy for a replacement if you see any unusual or missing pills. If you are uncertain, check with your pharmacist. Examples of unusual pills include ones with chips, jagged edges, pieces missing, or the wrong shape or colour.
    • Check both sides of each pill before taking it as it may not be obvious from looking at the blister package that there is a problem with the pills.
  • Do not consume an active (hormone-containing) pill if it looks unusual. If you cannot get to a pharmacy right away, take the next normal-looking active pill in the package. Do not miss an active pill as this may result in pregnancy.
    • If you have no normal-looking active pills left, 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. As noted in the prescribing information, it’s important to have another kind of birth control to use as back-up if you miss pills.
  • Packages that have no missing or unusual pills do not need to be returned.
  • 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.

Who is affected

  • Women who take birth control pills
  • Health professionals who dispense these products

What industry professionals should do

  • Health care professionals such as pharmacists are advised to remind patients to:
    • check tablets before taking them and not consume pills that are damaged,
    • return blister packages containing damaged, missing or extra pills to the pharmacy for a replacement, and
    • seek counsel on the proper use of oral contraceptives, and on what to do if they miss a dose.
  • Report any unusual packages to the company and to Health Canada.

Background

Health Canada has recently communicated about instances of quality concerns involving Alesse and Alysena birth control pills (see links below). Health Canada continues to receive complaints of quality issues and is reminding women to always check their pills before taking them.

This communication is prompted by two recent complaints involving Alesse 28. In one complaint, two active pills were missing from their slots and a third slot in the blister package contained a pill fragment where a whole pill should have been (see image below). In the second complaint, a pill shifted from one slot to another, causing two pills to be found in one slot and a second slot to have no pill in it (see image below).

Health Canada is providing this advice as a general reminder and is not suggesting that there are issues with all birth control pills.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada continues to follow up with companies as necessary to make sure appropriate measures are taken to correct any quality issues. We will continue to monitor and assess the need for further action. Health Canada will update consumers and health care professionals as appropriate.

Images

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