Discontinuation of Sales of Nefazodone in Canada: Letter to Pharmacists and Wholesalers

Date: 2003-10-23

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MHPD DPSC

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Bristol-Myers Squibb Canada.
Contact the company for a copy of any references, attachments or enclosures.

The following is duplicated text of a letter from Bristol-Myers Squibb Canada directed to pharmacists and pharmaceutical wholesalers. This notification is further to a Health Professional Communication issued by Bristol-Myers Squibb Canada on October 2, 2003.

October 2003

Dear Pharmacist / Wholesaler

Immediate Attention Required
All Lots of Serzone-5HT₂ 50 mg, 100 mg, 150 mg, 200 mg

Discontinuation of sales: Serzone-5HT₂ (nefazodone HCl)

PRODUCT	STRENGTH	PRODUCT CODE	DIN	UPC
Serzone-5HT2*	50 mg	003131	02087294	623131001489
Serzone-5HT2*	100 mg	003280	02087375	623131000543
Serzone-5HT2*	150 mg	003980	02087383	623131000550
Serzone-5HT2*	200 mg	003380	02087391	623131000567

* nefazodone hydrochloride, USP

As mentioned in the enclosed letter, as of November 27, 2003, the sales of Serzone-5HT₂ (nefazodone HCl) will be discontinued in Canada. In order to enhance patient safety and allow physicians the opportunity to counsel their patients concerning alternate treatment options, the product should be made available until November 27, 2003, at which time all distribution and dispensing must cease, so that no further sales should occur after November 27, 2003. In order to assist physicians in protecting the well being of their patients during this transition period, these products should be made available until November 27, 2003 and no product should be returned to Bristol-Myers Squibb Canada (BMSC) at this time. BMSC will be sending a second letter on November 27+1 day which will include a fax back form to identify all remaining inventory and a product credit form.

Please inform your customers that they should not discontinue taking Serzone-5HT₂ without first consulting with their physician. Please immediately refer any customer seeking Serzone-5HT₂ to their doctor for consultation.

If you have any questions about this discontinuation of sales, please call our Customer Services at 1-800-267-0005. We regret any inconvenience and appreciate your cooperation.

Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.