Riva-Quetiapine (quetiapine fumarate) - Voluntary Recall Due to Possible Contamination Issues - For Health Professionals

Starting date:

May 17, 2013

Posting date:

May 21, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination

Audience:

Healthcare Professionals

Identification number:

RA-29297

This is duplicated text of a letter from Laboratoire Riva Inc. Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on RIVA-QUETIAPINE (quetiapine fumarate) tablets

May 17, 2013

Dear Health Care Professional,

Subject: Voluntary recall of RIVA-QUETIAPINE (quetiapine fumarate) 25 mg (DIN 02316692), 100 mg (DIN 02316706), 200 mg (DIN 02316722) and 300 mg tablets (DIN 02316730) due to potential presence of trace amounts of Clindamycin hydrochloride in the tablets.

Laboratoire Riva Inc., in consultation with Health Canada, is writing to advise you that the supplier of quetiapine fumarate active pharmaceutical ingredient (API) to Laboratoire Riva Inc. may have inadvertently caused trace amounts of clindamycin hydrochloride to be present in the quetiapine raw material. Exposure to clindamycin, no matter how minor, may increase the risk of potentially serious allergic adverse drug reactions, in people taking Riva-Quetiapine tablets, particularly in those who are allergic or may also be sensitive to clindamycin hydrochloride or lincomycin hydrochloride. Quetiapine is an antipsychotic agent indicated for the management of schizophrenia and bipolar disorder in adult patients and is not indicated for use in patients who are under 18 years of age.  A voluntary recall has been initiated for Riva-Quetiapine products currently on the Canadian market and a list of the affected lot numbers is attached to this letter.

The population at risk is those who are susceptible or hypersensitive to clindamycin hydrochloride or lincomycin hydrochloride. The most common hypersensitivity reaction is generalized mild to moderate morbilliform-like (maculopapular) skin rashes. However, vesiculobullous rashes, urticaria, rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported during drug therapy with clindamycin at recommended doses. 

• A voluntary recall of Riva-Quetiapine products has been initiated due to potential for trace amounts of clindamycin in affected quetiapine products and possible risk of serious allergic adverse reactions, particularly in those who are hypersensitive to clindamycin or lincomycin.
• Health care professionals are advised to contact their patients who have been supplied with any Riva-Quetiapine product and ensure a safe transition over to an alternative quetiapine product which is not subject to recall or, to another product authorised for the Canadian market. Increased monitoring is recommended during the transition period.
• Patients should not abruptly discontinue their treatment but contact their health care professional to obtain medical advice.

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

For most adult patients, exposure to trace amounts of clindamycin hydrochloride will not represent a health risk. However, the data in the literature indicates a possibility of hypersensitivity in some patients. The prevalence of clindamycin hypersensitivity is expected to be less than 1%.

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 reaction or other serious or unexpected adverse reactions in patients receiving Riva-Quetiapine tablets should be reported to Laboratoire Riva Inc. or Health Canada.

Laboratoires Riva Inc.
660, Boulevard Industriel, Blainville,
QC, Canada
450-434-7482 ext 237

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

You can also 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:
Lead Directorate: Health Product and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636 

Please be assured that the health and safety of your patients is our primary concern.  

Sincerely,

Original signed by

Adriana Petrulian
Director, Quality & Reg. Affairs

References:

1. Riva-Quetiapine (Quetiapine fumarate) Tablets, Product Monograph , Control # 124547, September 11, 2008
2. DALACIN C, (Clindamycin Hydrochloride Capsules USP) Product Monograph, revised November 8, 2012
3. US Prescribing Information. Clindamycin Hydrochloride Capsules. Actavis, Inc. September 2012. 
4. Mazur N, Greenberger PA, Regalado J. Clindamycin hypersensitivity appears to be rare. Ann Allergy Asthma Immunol. May 1999;82(5):443-5