ALESSE 21 and ALESSE 28: Packages Containing Broken or Split Tablets

Starting date:

December 9, 2017

Posting date:

December 11, 2017

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Quality, Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-65368

• Issue
• Who is affected
• Report health or safety concerns
• Images

Further to the Public Advisory that was issued on December 1^st 2017 (link provided at the bottom of this page), Health Canada would like to provide further information to assist health care professionals in advising their patients who use Alesse.

Audience

Health care professionals including physicians, pharmacists and nurses

Key messages

• Blister packages for ALESSE 21 and ALESSE 28 were found to contain one broken pink tablet in a sealed blister.
• Broken or split birth control tablets may deliver a smaller dose of the active drug ingredients, which could reduce its effectiveness in preventing pregnancy.
• Health care professionals are advised to remind the patients to:
  • check tablets before taking them and not consume tablets that are broken or split; 
  • return blister packages containing broken or split tablets to the pharmacy to get a replacement package; and
  • seek counsel on the proper use of oral contraceptives, and on what to do if they miss a dose.

      

Issue

Health Canada and Pfizer Canada Inc. have received reports for packages of ALESSE 21 and ALESSE 28 where the blister packages contained a single active (pink) tablet that was broken (see pictures below). This could reduce the dose of hormones and potentially result in an unintended pregnancy due to insufficient action of the contraceptive hormones levonorgestrel and ethinyl estradiol.

Products affected

ALESSE 21 (Levonorgestrel and Ethinyl Estradiol), DIN 02236974
ALESSE 28 (Levonorgestrel and Ethinyl Estradiol), DIN 02236975

Background information

ALESSE is a prescription medicine used for:

• Conception control.
• Treatment of moderate acne vulgaris in women ≥14 years of age who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche.

The ALESSE 21 consists of 21 pink tablets containing active ingredients.  ALESSE 28 consists of 21 pink tablets containing active ingredients, followed by 7 days of white tablets containing placebo.

During manufacturing, it is possible for tablets to break or split. However, as the manufacturing process is well controlled, these problems rarely occur and Pfizer considers these cases to be isolated incidents. The overall quality of the intact tablets is not affected.

There is a chance the consumer may decide not to take the broken tablet. This could reduce the dose of hormones and potentially result in an unintended pregnancy due to insufficient action of the contraceptive hormones levonorgestrel and ethinyl estradiol.¹  

Who is affected

Information for consumers

ALESSE is a birth control tablet (oral contraceptive) that contains two female sex hormones (levonorgestrel and ethinyl estradiol). Packages of ALESSE 21 should have two rows of pink (active) tablets. Packages of ALESSE 28 should have two rows of pink (active) tablets and one row of white inactive (no hormones) tablets.

Patients are advised to thoroughly check their ALESSE birth control tablets before and after taking them out of the blister package to ensure that the tablets are not broken or split. Patients should not take tablets that are broken or split. Packages containing broken or split tablets should be returned to the pharmacy for a replacement. Patients should not stop taking birth control tablets unless advised to do so by their health care provider, as they could get pregnant. Patients should talk to their health care provider if they have questions or concerns about their birth control product.

Information for healthcare professionals

Pfizer Canada Inc. advises health care professionals to remind their patients of the following:

• Check tablets before and after taking them out of the blister package.
• Examine both sides of each tablet thoroughly to determine if the tablet is broken or split. It may not be immediately obvious from looking at the blister package, as the underside of the tablet cannot be seen while in the blister package;
• If a package has a broken or split tablet, return it to the pharmacy for a replacement package.
• Do not consume a tablet if it’s broken or split.
• To not stop taking birth control tablets as this will increase the likelihood of pregnancy. For questions or concerns about birth control products, talk to a health care professional, including about alternatives.
• Read the Consumer Information Leaflet included in the ALESSE packaging for detailed instructions in case of a missed dose.

Action taken by Health Canada

Health Canada is communicating this important safety information to health care professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect e-Notice™ email notification system.

Health Canada continues to monitor the situation and the implementation of corrective and preventative actions by the manufacturer.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of pregnancy or other serious or unexpected side effects in patients receiving ALESSE 21 and ALESSE 28 should be reported to Pfizer Canada Inc. or Health Canada.

Pfizer Canada Inc. Contact Information
17300 Trans-Canada Highway
Kirkland, QC
H9J 2M5

Telephone: If you have an inquiry of a medical nature related to ALESSE 21 and ALESSE 28, please contact our Medical Information Group at 1-800-463-6001 (Monday – Friday 9AM-5PM). For all other inquiries, please contact our Customer Service Group at 1-800-387-4974.

To report an adverse event (or suspected side-effect) experienced with a Pfizer medication (prescription, non-prescription or a vaccine) please contact Pfizer at 1-866-723-7111 or by fax at 1-855-242-5652.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Please refer to Pfizer.ca for the ALESSE 21 and ALESSE 28 Product Monograph and for an electronic copy of this communication.

Sincerely,

Original signed by

Vratislav Hadrava M.D., Ph.D.
Vice-President and Medical Director
Pfizer Canada Inc.

References
1.    ALESSE (levonorgestrel and ethinyl estradiol) Product Monograph. Kirkland (QC). ^® T.M. Wyeth, Pfizer Canada Inc., Licensee; 2017.
 

Images

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