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ARCHIVED - Canadian Adverse Reaction Newsletter, Volume 15, Issue 1, January 2005

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Date: 2005-01-04

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Contact: Marketed Health Products Directorate

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This quarterly publication alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. It is a useful mechanism to disseminate information on suspected adverse reactions to health products occurring in humans before comprehensive risk-benefit evaluations and regulatory decisions are undertaken. The continuous evaluation of health product safety profiles depends on the quality of your reports.

Reporting Adverse Reactions
Contact Health Canada
or a Regional AR Centre
free of charge
Phone: 866 234-2345
Fax: 866 678-6789

Click here for the Adverse Reaction Reporting Form.

Caveat: Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.

Telithromycin (Ketek) and warfarin: suspected interaction

Telithromycin (Ketek) is a novel antimicrobial that belongs to a new chemical family, the ketolides.1 Ketolides are recent additions to the macrolide-lincosamide streptogramin class1 and are designed to treat macrolide-resistant respiratory tract pathogens.2 3The Ketek product monograph states that, in a study involving healthy volunteers, there were no pharmacodynamic or pharmacokinetic effects on racemic warfarin.1

From May 29, 2003 (the date of marketing in Canada) to Sept. 15, 2004, Health Canada received 25 reports of suspected adverse reactions involving telithromycin. Seven reports were of coagulation disorders, 6 of which involved an interaction with warfarin and 1 an interaction with an unspecified oral anticoagulant. The patients' ages ranged from 50 to 79 years. The international normalized ratio (INR) was increased in 6 of the 7 reports and decreased in 1. Five patients had an INR that had previously been stabilized with warfarin; in the other 2 reports this information was not provided. Depending on when the patient's INR was due to be monitored, the change in INR was noted from 1 to 9 days after initiation of telithromycin. In 6 of the 7 cases, changes in one or both of the warfarin and telithromycin doses were required.

Telithromycin is metabolized by cytochrome P450 3A4 (CYP3A4) and to a lesser extent by cytochrome P450 1A (CYP1A).1 Warfarin exists as a racemic mixture of R- and S-warfarin. The S-isomer, metabolized by CYP2C9, is primarily responsible for the hypoprothrombinemic activity. The R-isomer, metabolized by CYP1A2 and to a lesser extent by CYP3A4, is less pharmacologically active than the S-isomer, but significant drug interactions have resulted from inhibition of its metabolism.2, 4

Proposed mechanisms of interaction between telithromycin and warfarin include the presence of infection affecting the activity of cytochrome P450 and inhibition of the metabolism of the warfarin R-isomer.1 Telithromycin is a substrate and inhibitor of CYP3A4. Its concentrations may be increased with concomitant administration of CYP3A4 inhibitors (e.g., ketoconazole), and telithromycin will increase the concentrations of other drugs metabolized by CYP3A4.5 Antibiotics have been reported to decrease the intestinal flora that produce vitamin K, reduced concentrations of which impair prothrombin production. Also, genetics, age, diet (e.g., vegetables rich in vitamin K), fever, stress and concomitant medication could modify the metabolism of warfarin and affect the intensity of the resulting interaction.6

Although it has been stated that telithromycin does not interact with warfarin,1, 7 the prothrombin time and INR should be monitored closely,2 especially in elderly patients, as should be the case whenever a new drug is started in a patient taking warfarin.

Ilhemme Djelouah, BScPhm, DIS, AFSA, Medical Biology (University of Paris V); Iza Morawiecka, BScPhm, Health Canada


  1. Ketek (telithromycin) [product monograph]. Laval: Aventis Pharma Inc.; 2003.
  2. Kolilekas L, Anagnostopoulos GK, Lampaditis I, Eleftheriadis I. Potential interaction between telithromycin and warfarin. Ann Pharmacother 2004;38(9):1424-7.
  3. Zuckerman JM. Macrolides and ketolides: azythromycin, clarithromycin, telithromycin. Infect Dis Clin North Am 2004;18(3):621-49.
  4. Michalets EL. Update: clinically significant cytochrome P-450 drug interactions. Pharmacotherapy 1998;18(1):84-112.
  5. Bearden DT, Neuhauser MM, Garey KW. Telithromycin: an oral ketolide for respiratory infections. Pharmacotherapy 2001;21(10):1204-22.
  6. Lauzon M. Place aux questions: Quels antibiotiques devraient-on éviter lors de la prise de la warfarine? Québec Pharmacie 2004;51(4):302-4.
  7. Fish DN. Telithromycin: a viewpoint by Douglas N. Fish. Drugs 2004;64(15):1695-6.

Linezolid (Zyvoxam) and neuropathy

Linezolid (Zyvoxam), a synthetic antibacterial agent in a new class of antibiotics, the oxazolidinones, has been marketed in Canada since Apr. 6, 2001.1 Linezolid is active against methicillin- and vancomycin-resistant gram-positive microorganisms. 2

The safety and efficacy of linezolid given for longer than 28 days have not been evaluated in controlled clinical trials.1 Dosage and administration guidelines recommend that treatment last no more than 28 consecutive days.1 Because of its activity against resistant organisms that cause osteomyelitis and prosthetic joint infections, linezolid has been used in clinical practice for longer than the recommended treatment course.2

The long-term use of linezolid has been associated with severe peripheral and optic neuropathy.2-4In most cases the optic neuropathy resolved after stopping the drug, but the peripheral neuropathy did not.4

Health Canada has received a report of a 71-year-old woman who received linezolid, 600 mg twice daily, for an acquired methicillin-resistant Staphylococcus aureus (MRSA) infection. The patient received an initial 6-week course of linezolid, stopped treatment for 4-5 months and was given the drug again for 8 months. Linezolid was stopped when the patient was admitted to hospital with anemia, pure red cell aplasia and severe peripheral neuropathy. She had initially noticed numbness in her feet a month previously. At the time of the report, the anemia had resolved but the neuropathy had not. Novo-Hydrazide was also considered a suspect drug.

Neuropathy (peripheral or optic) has rarely been reported in patients treated with linezolid and has primarily occurred in patients treated for more than the maximum recommended duration of 28 days.1 Myelosuppression including anemia is listed in the product monograph under warnings and postmarketing experience.1 Pure red cell aplasia is not listed in the product monograph.1

Health care professionals must be aware of the potential for serious adverse reactions, including neuropathy, when linezolid is used beyond its recommended duration.2 Spontaneous reporting of adverse reactions is an important aspect of postmarketing surveillance and contributes to maintaining the most up-to-date safety information on health products.

Debra Willcox, BSP, Health Canada


  1. Zyvoxam (linezolid) [product mongraph]. Mississauga (ON): Pharmacia Canada Inc; 2002.
  2. Rho JP, Sia IG, Crum BA, Dekutoski MB, Trousdale RT. Linezolid-associated peripheral neuropathy. Mayo Clin Proc 2004;79(7):927-30. Ann Allergy Asthma Immunol
  3. 3. Lee E, Burger S, Shah J, Melton C, Mullen M, Warren F, Press R. Linezolid-associated toxic optic neuropathy: a report of 2 cases. Clin Infect Dis 2003;37(10):1389-91.
  4. 4. Bressler AM, Zimmer SM, Gilmore JL, Somani J. Peripheral neuropathy associated with prolonged use of linezolid. Lancet Infect Dis 2004;4(8):528-31.

Safe use of health products containing camphor and eucalyptus oils

Camphor and eucalyptus oils are contained in many over-the-counter health products, including topical rubs and products used for steam inhalation in the management of coughs and colds. Because these products are generally thought to be without health risks, they are often left accessible to young children, who may accidentally ingest them. Simple precautions, such as carefully reading the product label warnings and storing the products away from the reach of children, can help in preventing accidental poisonings. Further consultation with a health care provider is advised with regard to the appropriate use of these products. More information on this topic is available in the It's Your Health article at

Adverse reaction reporting by health professionals and consumers

Why report?

All marketed health products have benefits and risks. Although health products are carefully tested for safety and efficacy before they are licensed, some adverse reactions* may not become evident until the general population uses a health product under "real life" circumstances. By submitting a suspected adverse reaction report, you are contributing to the ongoing collection of safety and effectiveness information that occurs once health products are marketed.

Reported adverse reaction information may contribute to:

  • the identification of previously unrecognized rare, or serious adverse reactions;
  • changes in product safety information, or other regulatory actions such as withdrawal of a product from the Canadian market;
  • international data regarding benefits, risks, or effectiveness of health products;
  • health product safety knowledge that benefits all Canadians.

What to report?

Health Canada, through the Canadian Adverse Drug Reaction Monitoring Program, is responsible for collecting and assessing adverse reaction reports for the following health products marketed in Canada: pharmaceuticals, biologics (including fractionated blood products as well as therapeutic and diagnostic vaccines), natural health products and radiopharmaceuticals.

You do not have to be certain that a health product caused the reaction in order to report it. Adverse reaction reports are, for the most part, only suspected associations.

We want to know about all suspected adverse reactions, but especially if they are:

  • unexpected adverse reactions, regardless of their severity (not consistent with product information or labelling);
  • serious adverse reactions †, whether expected or not;
  • adverse reactions related to recently marketed health products (on the market for less than 5 years).

When to report?

As soon as possible!

How to report?

Complete the adverse reaction reporting form which can be obtained at:

  • by contacting your Regional Adverse Reaction Centre:
    Toll-free phone: 1-866-234-2345
    Toll-free fax: 1-866-678-6789
  • in the CPS (Compendium of Pharmaceuticals and Specialties) publication.

Submit the report:

  • By toll-free fax: 1-866-678-6789
  • By toll-free phone: 1-866-234-2345
  • Calls are automatically directed to the National or a Regional Adverse Reaction (AR) Centre.
  • By mail (see below for addresses of the National and Regional AR Centres)

Keep informed:

By subscribing to Health Canada's MedEffect e-Notice mailing list. You will automatically receive the most recent Canadian Adverse Reaction Newsletter and health product advisories free by e-mail. Go to

* adverse reaction = side effect
† A serious adverse reaction is one that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent one of these outcomes are also considered to be serious.

National and regional adverse reaction centres

British Columbia
British Columbia Regional AR Centre
c/o BC Drug and Poison Information Centre
1081 Burrard St.
Vancouver BC V6Z 1Y6

Saskatchewan Regional AR Centre
c/o Saskatchewan Drug Information Service
College of Pharmacy and Nutrition
University of Saskatchewan
110 Science Place
Saskatoon SK S7N 5C9

Ontario Regional AR Centre
c/o LonDIS Drug Information Centre
London Health Sciences Centre
339 Windermere Rd.
London ON N6A 5A5

Québec Regional AR Centre
c/o Drug Information Centre
Hôpital du Sacré-Coeur de Montréal
5400, boul. Gouin ouest
Montréal (QC) H4J 1C5

Atlantic Regional AR Centre For New Brunswick, Nova Scotia, Prince Edward Island,
and Newfoundland and Labrador
c/o Queen Elizabeth II Health Sciences Centre
Drug Information Centre
2421-1796 Summer St.
Halifax NS B3H 3A7

All other provinces and territories
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
Ottawa ON K1A 0K9

Reporting adverse incidents associated with medical devices:
Health Products and Food Branch Inspectorate
Health Canada
AL 3002C
Ottawa, ON K1A 0K9
Medical Devices Hotline 800 267-9675

Visit Health Canada's Web site to obtain copies of the Medical Devices Problem Report Form and guidelines on mandatory and voluntary problem reporting for Medical Devices.

Caffeine-containing natural weight loss product and myopathy

A 47-year-old woman experienced muscle twitching over 4 months while taking the product Hydroxycut (Ephedra Free, by MuscleTech) for weight loss. The patient complained of muscle pain and weakness. Examination indicated fasciculations of the calf muscles and a creatine kinase (CK) level of 1021 (normally ≤ 190) U/L. Within 5 days of discontinuing the product, muscle symptoms resolved, and the CK values approached normal. Although no pre-existing medical conditions were noted, concomitant medications included Lomotil, Motilium, Nexium and Symbicort Turbuhaler.

Although Hydroxycut is not authorized for sale in Canada, it is used as a weight loss or bodybuilding product. The product was reformulated to be ephedra-free in January 2003. The new formulation, according to the product label, contains calcium, chromium, potassium, Hydroxagen Plus (which contains Garcinia cambogia extract, glucomannan, alpha lipoic acid, willow bark extract and L-carnitine) and Hydroxy Tea (which contains green tea leaf extract, caffeine and guarana extract standardized for 200 mg caffeine).

The association between caffeine intoxication and rhabdomyolysis has been documented.1 2Two cases of rhabdomyolysis associated with weight loss or bodybuilding products that contain G. cambogia or guarana or both, as in Hydroxycut, have been reported in the literature. One involved a product containing guarana, ephedrine, chitosan, Gymnema sylvestre, G. cambogia and chromium,3while an earlier case was associated with a product containing guarana, ginkgo and kava.4It is also possible that other ingredients contained in Hydroxycut (Ephedra Free), such as G. cambogia (which contains hydroxycitric acid) and chromium picolinate, may play a role in the development of rhabdomyolysis.5

Natural health products used for weight loss and bodybuilding may contain caffeine from a variety of natural sources, including guarana, green tea, kola nut and yerba maté. Consumers may unknowingly increase their intake of caffeine significantly and thereby increase their risk of caffeine-related adverse reactions, including rhabdomyolysis.

Jenna Griffiths, MSc, PhD; Karen Pilon, RN, Health Canada


  1. Wrenn KD, Oschner I. Rhabdomyolysis induced by a caffeine overdose. Ann Emerg Med 1989;18(1):94-7.
  2. Kamijo Y, Soma K, Asari Y, Ohwada T. Severe rhabdomyolysis following massive ingestion of oolong tea: caffeine intoxication with coexisting hyponatremia. Vet Hum Toxicol 1999;41(6):381-3.
  3. Mansi IA, Huang J. Rhabdomyolysis in response to weight-loss herbal medicine. Am J Med Sci 2004;327(6):356-7.
  4. Donadio V, Bonsi P, Zele I, Monari L, Liguori R, Vetrugno R, Albani F, Montagna P. Myoglobinuria after ingestion of extracts of guarana, Ginkgo biloba and kava. Neurol Sci 2000;21(2):124.
  5. Scroggie DA. Rhabdomyolysis associated with nutritional supplement use. In: VR Preedy VR, Watson RR, editors. Reviews in food and nutrition toxicity. London: Taylor & Francis, 2003. p.121-8.

Ceftriaxone (Rocephin) and immune hemolytic anemia in children

Ceftriaxone (Rocephin), marketed in Canada since Dec. 31, 1987, is a third-generation cephalosporin indicated for the treatment of susceptible strains of bacteria, as well as for prophylaxis against infections in patients undergoing hysterectomy, coronary artery bypass surgery or biliary tract surgery.1 Immune hemolytic anemia (IHA) is a hypersensitivity adverse reaction (AR) known to occur in adults and children. The Rocephin product monograph describes autoimmune hemolytic anemia as a rare AR (< 0.1% of cases),1 but does not mention IHA.

Ceftriaxone antibodies appear to be induced by an immune complex mechanism during a sensitization phase after initial exposure to the drug. 2 Intravascular hemolysis may be triggered after subsequent re-exposure. The signs and symptoms of drug-induced IHA include severe hemolytic anemia, hemoglobinuria, hypotension, acute renal failure, fever and back pain.3

From Jan. 1, 1988, to Sept. 15, 2004, Health Canada received 1 report of acute hemolysis suspected of being associated with ceftriaxone. A young child with sickle cell disease had been given a single dose of ceftriaxone (80 mg/kg body weight) intravenously for fever and cough, and within 30 minutes developed a rash, pallor and decreased level of consciousness. Laboratory examination showed a positive direct Coomb's test result, a hemoglobin level of 7 g/L (the pre-infusion level was 110 g/L) and hemolyzed red blood cells. The following day, the patient died despite resuscitation attempts. The only concomitant medication was a single oral dose of erythromycin. The patient had been exposed to ceftriaxone in the past.

Nine pediatric cases of IHA associated with exposure to ceftriaxone were identified in the literature, 6 of which were fatal.4-12One child with sickle cell anemia received ceftriaxone on several occasions and experienced 6 episodes of unexplained transient hemoglobinuria before the onset of the IHA.10

Drug-induced IHA is associated with a high mortality rate.3 Other than supportive care and red blood cell transfusion, there are few effective treatment options. Reintroduction of the drug is contraindicated because of the high risk of recurrence of hemolysis, which is often more severe.3

IHA associated with ceftriaxone is rare and has been reported to occur with repetitive, intermittent use of this drug. Children with underlying conditions such as hemoglobinopathies and immunodeficiencies are likely to require frequent treatment or prophylaxis with ceftriaxone, which may place them at increased risk of IHA. The development of signs and symptoms of IHA, including hemoglobinuria or unexplained anemia, should prompt health care professionals to consider this diagnosis and the discontinuation of the suspect drug.3

Lise Watters, MD, FRCPC; Debra Willcox, BSP, Health Canada


  1. Rocephin (ceftriaxone) [product monograph]. Mississauga (ON): Hoffman-La Roche Limited; 1997.
  2. Arndt PA, Leger RM, Garratty G. Serology of antibodies to second- and third-generation cephalosporins associated with immune hemolytic anemia and/or positive direct antiglobulin tests. Transfusion 1999;39(11-12):1239-46.
  3. Solal-Celigny P. Abnormal hematologic values. In: Benichou C, editor. Adverse drug reactions. A practical guide to diagnosis and management. Chichester: John Wiley and Sons Ltd.; 1994. p. 13-30.
  4. Mattis LE, Saavedra JM, Shan H, Shirey RS, Powell E, Oliva-Hemker MM. Life-threatenting ceftriaxone-induced immune hemolytic anemia in a child with Crohn's disease. Clin Pediatr (Phila) 2004;43(2):175-8.
  5. Citak A, Garratty G, Ucsel R, Karabocuoglu M, Uzel N. Ceftriaxone-induced haemolytic anaemia in a child with no immune deficiency or haematological disease. J Paediatr Child Health 2002;38(2):209-10.
  6. Viner Y, Hashkes PJ, Yakubova R, Segal-Kupershmit D, Luder AS. Severe hemolysis induced by ceftriaxone in a child with sickle-cell anemia. Pediatr Infect Dis J 2000;19(1):83-5.
  7. Meyer O, Hackstein H, Hoppe B, Gobel FJ, Bein G, Salama A. Fatal immune haemolysis due to a degradation product of ceftriaxone. Br J Haematol 1999;105(4):1084-5.
  8. Scimeca PG, Weinblatt ME, Boxer R. Hemolysis after treatment with ceftriaxone. J Pediatr 1996;128(1):163.
  9. Moallem HJ, Garratty G, Wakeham M, Dial S, Oligario A, Gondi A, et al. Ceftriaxone-related fatal hemolysis in an adolescent with perinatally acquired human immunodeficiency virus infection. J Pediatr 1998;133(2):279-81.
  10. Bernini JC, Mustafa MM, Sutor LJ, Buchanan GR. Fatal hemolysis induced by ceftriaxone in a child with sickle cell anemia. J Pediatr 1995;126(5 Pt 1):813-5.
  11. Lascari AD, Amyot K. Fatal hemolysis caused by ceftriaxone. J Pediatr 1995;126(5 Pt 1):816-7.
  12. Borgna-Pignatti C, Bezzi TM, Reverberi R. Fatal ceftriaxone-induced hemolysis in a child with acquired immunodeficiency syndrome. Pediatr Infect Dis J 1995;14(12):1116-7.

Case Presentation

Recent Canadian cases are selected based on their seriousness, frequency of occurrence or the fact that the reactions are unexpected. Case presentations are considered suspicions and are presented to stimulate reporting of similar suspected adverse reactions.

Olanzapine (Zyprexa): suspected association with pulmonary embolism

A 22-year-old man (weight 95 kg, height 1.78 m) was prescribed Zyprexa, 20 mg at bedtime. About 6 months after the start of treatment he was admitted to hospital with a massive bilateral pulmonary embolism, confirmed by chest CT. An electrocardiogram revealed a normal sinus rhythm. The patient did not have deep venous thrombosis (DVT), and results of venous Doppler ultrasonography of the legs performed 3 days after admission were normal. Celexa, 20 mg/d, was the only concomitant medication reported. The patient had a prior history of depression, had borderline autism and smoked half a pack of cigarettes a day. His father had a history of DVT. Results of tests for inherited DVT (e.g., tests for prothrombin gene mutation, Factor V mutation, protein C, protein S and activated protein C resistance) were negative. The patient was treated with Lovenox and then warfarin. Zyprexa was tapered off, and risperidone was gradually started. Similar cases have been described in the literature.1 2


  1. Waage IM, Gedde-Dahl A. Pulmonary embolism possibly associated with olanzapine treatment. BMJ 2003;327(7428):1384.
  2. Curtin F, Phil M, Schulz P. Psychotropic drugs and fatal pulmonary embolism: a comment. Pharmacoepidemiol Drug Safety 2004;13:659-60.

Summary of health professional and consumer advisories

Date Product Subject and type
Nov 16 Drugs Obligations of pharmacists under the Food and Drugs Act and Regulations
- letter to pharmacists
Nov 4 & Oct 29 Carbolith Drug stability failure of a few lots of Carbolith 150 mg capsules
- Valeant Canada Limited
- consumer information and health professional communication
Oct 27 Oral-B
and refills
Urgent product removal: Oral-B CrossAction Power and PowerMAX toothbrushes and refills
- Gillette
- consumer information
Oct 20 Ultrasound and
medical gels
Risk of serious infection from ultrasound and medical gels
- notice to hospitals
Oct 18 & 13 Eprex Association of Eprex (epoetin alfa) with thrombotic vascular events
- Janssen-Ortho Inc.
- consumer information and health professional communication
Oct 14 Euro-K Update on Euro-K recall lot EKT 404 and lot EKT 405
- letter to pharmacists
Oct 12 Permax New safety information regarding Permax and occurrence of cardiac valvulopathy / fibrosis
- Shire Biochem Inc.
- consumer information and health professional communication
Oct 1 Vioxx Merck Sharp & Dohme (MSD) announces voluntary worldwide withdrawal of Vioxx (rofecoxib)
- Merck Frosst Canada Ltd
- letter to pharmacists and health professional communication
Sept 30 Vioxx Health Canada informs Canadians of Vioxx withdrawal by Merck & Co.
- consumer information
Sept 29 Cochlear
Notification to Clarion 1.2 cochlear implant users; Notification to Clarion CII cochlear implant users; Notification to HiRes 90K cochlear implant users
- Advanced Bionics
- consumer information
Sept 27 Cochlear
Recall notification for all unused Advanced Bionics implantable cochlear stimulators
- Advanced Bionics
- health professional communication
Sept 7 LTV series
Safety information on the LTV series ventilators - Pulmonetic Systems
- consumer information
Sept 2 & 1 Euro-K and
Important safety information on Euro-K and Riva-K sustained release potassium supplements
- consumer information and health professional communication
Sept Lamictal Important safety information for patients taking Lamictal (lamotrigine) - GlaxoSmithKline Inc.
- consumer information and health professional communication

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Canadian Adverse Reaction Newsletter

Marketed Health Products Directorate
AL 0701B
Ottawa ON K1A 0K9
Tel 613 954-6522
Fax 613 952-7738

Health professionals/consumers report toll free:
Tel 866 234-2345
Fax 866 678-6789

Editorial Staff
Ann Sztuke-Fournier, BPharm (Editor-in-Chief)
Ilhemme Djelouah, BScPhm, DIS, AFSA, Medical Biology (University of Paris V)
Karen Kouassi, MSc
Gilbert Roy, BPharm

Expert Advisory Committee on Pharmacovigilance,
Regional AR Centres and Health Canada staff

Your comments are important to us. Let us know what you think by reaching us at

Her Majesty the Queen in Right of Canada, 2004. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.

ISSN 1499-9447, Cat no H42-4/1-15-1E

USPS periodical postage paid at Champlain, NY, and additional locations.

Aussi disponible en français.

Caveat: Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.