Advisory for Demulen 30 Oral Contraceptive Pill Users

Health Canada has issued an advisory (not a recall) for Demulen pill users (28 day package and DIN 00471526) to ensure the pills they are using are in tact and not chipped or broken as there have been reports of broken or chipped pills. Chipped or broken pills may result in a user receiving less active ingredient than they need to reduce the risk of pregnancy.

We are advising all of our Demulen 28 users to inspect each pill outside of the packaging before taking them. If you have any concerns, please call us 250-592-3479. We also always recommend pairing a condom with the birth control pill to reduce risk of pregnancy and STIs. If you discover a broken or chipped pill, contact us for more information and we can advise you about the next steps.

The following is the Health Canada advisory:

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 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.

What you should do

• Return your package to the prescribing centre 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.