Apo-Clindamycin, Clindamycine-150 and Clindamycine-300 (clindamycin hydrochloride) - Presence of Trace Amounts of Quetiapine Fumarate in the Capsules - For Health Professionals

Starting date:

May 25, 2013

Posting date:

May 25, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination

Audience:

Healthcare Professionals

Identification number:

RA-33633

This is duplicated text of a letter from Apotex Inc. and Pro-Doc Limitée. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on APO-CLINDAMYCIN, CLINDAMYCINE-150 and CLINDAMYCINE-300

May 25, 2013

Dear Health Care Professional,

Subject: Risk of potentially serious allergic reaction in patients who are allergic or hypersensitive to quetiapine fumarate taking APO-CLINDAMYCIN, CLINDAMYCINE -150, and CLINDAMYCINE – 300

Apotex Inc. and Pro Doc Ltée, in consultation with Health Canada, are writing to advise you that the third party fabricator of clindamycin hydrochloride active pharmaceutical ingredient (API) to Apotex Inc. and Pro Doc Ltée may have inadvertently caused trace amounts of quetiapine fumarate to be present in the clindamycin hydrochloride raw material. Exposure to quetiapine fumarate in trace amounts in patients who are allergic or hypersensitive to quetiapine fumarate may cause a serious allergic reaction.

APO-CLINDAMYCIN, CLINDAMYCINE - 150 and CLINDAMYCINE – 300 contain clindamycin hydrochloride, an antibiotic, which is used to treat many infections. Some examples of uses of clindamycin are: to treat infections in patients who are allergic to penicillin, in cases when other antibiotics are not effective, before dental, oral and upper respiratory tract surgery, and for pneumonia in AIDS patients.

Clindamycin is considered a medically necessary drug. As Apotex and Pro Doc currently supply about 75% of the Canadian market needs for Clindamycin, taking steps to ensure continued patient access to this medication is of utmost importance. As a result, the advisory is only directed to the specific group of patients identified in the bullets below.

Patients with a history of known allergy or hypersensitivity to quetiapine fumarate should not be prescribed or dispensed APO-CLINDAMYCIN, CLINDAMYCINE - 150 or CLINDAMYCINE - 300. The population at risk is those individuals who have a known history of allergy or hypersensitivity to quetiapine fumarate. Uncommon cases of hypersensitivity including angioedema and very rarely anaphylactic reactions have been reported.

• The active pharmaceutical ingredient used in APO-CLINDAMYCIN, CLINDAMYCINE - 150 and CLINDAMYCINE - 300, may have trace amounts of quetiapine fumarate. The population at risk is those patients prescribed APO-CLINDAMYCIN, CLINDAMYCINE - 150 and CLINDAMYCINE - 300, with a known allergy or hypersensitivity to quetiapine fumarate.
• Health Care Professionals are advised to contact their patients who have been prescribed APO-CLINDAMYCIN, CLINDAMYCINE - 150 and CLINDAMYCINE - 300, and ensure that they have no history of allergy or hypersensitivity to quetiapine fumarate.
• Additionally, health care professionals should inquire about hypersensitivity or allergy to quetiapine before prescribing APO-CLINDAMYCIN, CLINDAMYCINE - 150 and CLINDAMYCINE - 300 to new patients.
• If there is a history of hypersensitivity or allergy, health care professionals are requested to switch the patient to another brand of clindamycin.

During a recent inspection by international inspectors from the European Directorate for the Quality of Medicines and Healthcare (EDQM), it was noted that the third party fabricator’s cleaning records for a piece of common equipment were found inadequate. While there is no evidence indicating that the clindamycin hydrochloride was in contact with quetiapine fumarate and no allergic adverse reactions have been reported to date, the presence of trace amounts of quetiapine fumarate on that common equipment has not been ruled out. As a precaution, it is necessary to bring the possibility of a potentially serious allergic reaction in patients allergic or hypersensitive to quetiapine fumarate to your attention.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious allergic reactions or other serious or unexpected adverse reactions in patients receiving APO-CLINDAMYCIN should be reported to Apotex Inc or Health Canada, and CLINDAMYCINE - 150 and CLINDAMYCINE – 300 to Pro Doc Ltée or Health Canada.

If you have a medical enquiry about APO-CLINDAMYCIN, please contact the Apotex’s Drug Information Service as per the contact information below:

APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Phone: 1-877-884-7828 or 1-800-667-4708
Fax: 1-855-311-5445 or 1-416-401-3884

To report an adverse drug reaction with APO-CLINDAMYCIN, please contact Apotex Drug Safety department as per the contact information below:

APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Phone: 1-800-667-4708
Fax: 1-416-401-3819
Email: Drugsafety@apotex.com

To correct your mailing address or fax number, contact Apotex Inc.

If you have a medical enquiry, or to report an adverse drug reaction, about CLINDAMYCINE – 150 or CLINDAMYCINE – 300 please contact the Pro Doc’s Drug Information Service as per the contact information below:

PRO DOC LTÉE
2925, Boul. Industriel
Laval, Québec
H7L 3W9
Phone: 1-800-361-8559
Fax: 1-888-977-6362
Email: medinfo@prodoc.qc.ca

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, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

Yours sincerely,

original signed by

Colin D’Cunha MBBS, MHSc, FRCPC
Director, Global Medical Affairs
Apotex Inc.

Marcel Lapointe, pharmacist
Director, Professional Services
Pro Doc Ltée

References:

1. Apo-Clindamycin Product Monograph. Apotex Inc. 2002
2. Apo-Quetiapine Product Monograph. Apotex Inc. 2008
3. Clindamycine Product Monograph. Pro Doc Ltée. 2003
4. Pro-Quetiapine Product Monograph. Pro Doc Ltée. 2008