Advisory - Demulen 30 birth control pills: Packages containing broken or chipped pills

OTTAWA, June 1, 2018 /CNW/ -

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Demulen 30 (28 pills) – package with one pill (circled in red) that has a large piece (top half) missing (CNW Group/Health Canada)

Issue
Pfizer Canada Inc. has notified Health Canada that it has received complaints of broken or chipped pills involving Demulen 30, a prescription birth control pill. Health Canada has previously communicated on similar issues involving two other brands of birth control pills. Health Canada continues to remind women to check their packages of birth control pills and to report problems if they see them. 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.

Who is affected

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

Affected products
Demulen 30 birth control packages that contain damaged or unusual pills.

What consumers 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.

Additional information for health professionals:

• 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.

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

Background
Health Canada has recently communicated about instances of quality concerns involving Alesse and Alysena birth control pills (see links below).

Pfizer Canada has advised that it has received complaints of broken or chipped pills in packages of Demulen 30 (28 day package, DIN 00471526). While the company indicates that the rate of occurrence is very low, Health Canada is reminding women to always check their pills before taking them. Health Canada is providing this advice as a general reminder and is not suggesting that there are issues with all birth control pills.

Related links

• Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual (2018-04-16)
• Chipped pills in additional packages of Alysena 21 and 28 birth control pills (2018-03-08)
• Alysena 28 birth control pill: One lot recalled due to chipped pills, which may reduce effectiveness in preventing pregnancy (2018-02-09)
• ALESSE 21 and ALESSE 28: Packages Containing Broken or Split Tablets (2017-12-09)
• Alesse 21 and 28 birth control pill: Packages may contain broken or smaller-than-normal pills, which may reduce effectiveness in preventing pregnancy (2017-12-01)

For more information
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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SOURCE Health Canada

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