Public advisory - Unauthorized drugs for abortion and emergency contraception sold illegally on "Dr. Pooja" websites

OTTAWA, ON, May 16, 2023 /CNW/ - 

Summary

• Product: Unauthorized products labelled to contain mifepristone and misoprostol (commonly known as the "abortion pill"), and unauthorized emergency contraceptive labelled to contain levonorgestrel (commonly known as the "morning after pill")
• Issue: Health products – Product safety
• What to do: Do not buy or use any unauthorized health products from "Dr. Pooja" websites. Only buy prescription drugs from licensed pharmacies. If you have taken unauthorized products labelled to contain mifepristone and misoprostol, seek immediate medical attention. If you have taken unauthorized emergency contraceptives labelled to contain levonorgestrel, speak to your health care professional. See below for more guidance for each product, as the risks and recommendations are unique for each.

Affected products

• Unauthorized prescription drugs labelled to contain mifepristone and misoprostol, for medical abortion
• Unauthorized over-the-counter drugs labelled to contain levonorgestrel, for emergency contraception

Issue

Health Canada is warning consumers not to buy unauthorized heath products to terminate or prevent pregnancy as they may pose serious health risks. Health Canada is aware (link available in French only) of two "Dr. Pooja" websites (https://www.drpoojaclinic.ca/ and http://drpoojacliniccynaecologist.com/) selling unauthorized prescription drugs for medical abortion labelled to contain mifepristone and misoprostol, and unauthorized over-the-counter drugs for emergency contraception labelled to contain levonorgestrel.

Selling unauthorized health products in Canada is illegal, and Health Canada will do everything it can to stop this activity. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they may be ineffective, expired, mislabeled, subject to recalls, or counterfeit versions of authorized products. Unauthorized drugs may have no active ingredients, the wrong ingredients, or dangerous additives such as prescription drugs not listed on the label.

Health Canada has directed the websites to stop selling unauthorized health products and is working to have the websites removed. Health Canada will take further action as necessary to protect the health and safety of people in Canada.

What you should do

• Do not buy or use any unauthorized health products from "Dr. Pooja" websites.
• If you have taken unauthorized products labelled to contain mifepristone and misoprostol from these websites, seek immediate medical attention to receive a proper health assessment and medical care.
• If you have taken unauthorized products labelled to contain levonorgestrel, speak to your health care professional to receive a proper health assessment and medical care.
• Return unauthorized drugs to your local pharmacy for proper disposal.
• Only buy prescription drugs from licensed pharmacies.
• Avoid buying health products from questionable or untrustworthy websites. Be aware of the risks of buying heath products online.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report any health product-related side effects or complaints to Health Canada.

Background

Unauthorized prescription drugs labelled to contain mifepristone and misoprostol: Mifepristone and misoprostol are prescription drug ingredients taken in sequence for the medical termination of a pregnancy. For safety, it is very important that patients have close medical supervision, guidance and care. The use of mifepristone and misoprostol is not suitable to terminate all pregnancies. For example, the drugs should not be used by people who are more than nine weeks (63 days) pregnant, who have a pregnancy outside the uterus (ectopic pregnancy), who have an intra-uterine contraceptive device, who have bleeding disorders or who are on a blood thinner therapy, who are on long-term corticosteroid therapy, who have uncontrolled asthma or who are allergic to mifepristone or misoprostol.

There is an authorized mifepristone and misoprostol combination product available in Canada, sold under the brand name Mifegymiso. Health Canada has put in place several safeguards for its safe and effective use, including access to emergency medical care and scheduled follow-up care. People who take unauthorized drugs without proper medical supervision are at an increased risk of severe infection (that could be fatal), prolonged heavy bleeding, serious skin reactions and birth defects (if the pregnancy is not successfully terminated).

Unauthorized emergency contraceptive labelled to contain levonorgestrel: Levonorgestrel is a non-prescription drug used as an emergency contraceptive to prevent pregnancy within 72 hours of known or suspected contraceptive failure or unprotected sex, when sold as a single ingredient oral dose containing no more than 1.5 milligrams. Unauthorized emergency contraceptives labelled to contain levonorgestrel may be ineffective and may not prevent pregnancy as expected. The drug should not be taken by those allergic to levonorgestrel, or by those who are, or who suspect they are pregnant. For patients with undiagnosed abnormal vaginal bleeding, a pregnancy test should be performed before taking levonorgestrel. Levonorgestrel as an emergency contraceptive does not induce abortion and should not be taken by pregnant women as it will not be effective. There are authorized levonorgestrel emergency contraceptive products available in Canada.

Également disponible en français

SOURCE Health Canada

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