Emergency contraceptive pills to carry warnings for reduced effectiveness in women over a certain body weight
- Starting date:
- March 26, 2014
- Posting date:
- March 26, 2014
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
- What you should do
- Report health or safety concerns
- Related AWRs
- Media enquiries
- Public enquiries
Emergency contraceptive pills, also known as the “morning after” pill, will soon carry new warnings about reduced effectiveness in women weighing over 165 pounds.
Health Canada has asked companies to add new warnings to product packages advising that these pills are less effective in women weighing 165 to 176 pounds (75-80 kg), and are not effective in women over 176 pounds (80 kg). Women who weigh 165 pounds or more are advised to ask a health professional, such as a doctor or pharmacist, for advice on alternative methods of emergency contraception.
In Canada, the following emergency contraceptive pills are available without a prescription:
- Next Choice (Cobalt Pharmaceuticals Company)
- Norlevo (Laboratoire HRA Pharma)
- Option 2 (Perrigo International)
- Plan B (Teva Women’s Health Inc.)
They are taken by women up to 72 hours after unprotected sex or a contraceptive accident (such as a condom breaking), to prevent pregnancy. The pills contain a higher dose of levonorgestrel compared to regular birth control pills with this hormone, and work by preventing ovulation or fertilization of an egg. They have no effect if a woman is already pregnant.
Health Canada has evaluated new data from Laboratoire HRA Pharma and approved the company’s submission to update Norlevo packaging and labelling, including the product monograph, with these warnings. Laboratoire HRA Pharma will be implementing the packaging changes over the next several months. Health Canada has sent letters to the other three Canadian manufacturers requesting they update the labelling and packages for their products as well.
Products without the updated warning statements will remain on pharmacy shelves during this transition time. Health Canada has provided information about the label changes to both the Canadian Pharmacists Association and the National Association of Pharmacy Regulatory Authorities so that pharmacists can consider these new warnings when giving advice to consumers.
What you should do
- For women who weigh 165 pounds (75kg) or more, talk to a health professional, such as a doctor or pharmacist, for advice on alternative methods of emergency contraception.
- Do not exceed dosing recommendations on the product label.
- Any woman with questions or concerns about emergency contraceptive products should talk to a healthcare professional.
Report health or safety concerns
- Call toll-free at 1-866-234-2345
- Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
- Date modified: