Canadian Adverse Reaction Newsletter, Volume 21 - Issue 4 - October 2011
Cat no H42-4/1-21-4E
Health Products and Food Branch
Marketed Health Products Directorate
Canadian Adverse Reaction Newsletter Editorial Team
In this Issue:
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 stimulate adverse reaction reporting as well as 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
Canada Vigilance Program
For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.
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.
Custom-Pak Ophthalmic Surgery Procedure Pack: contamination with foreign bodies and risk of related complications
- Health Canada received 28 reports of incidents suspected of being associated with contamination of the surgical pack with lint, fibre or particles.
- Fourteen patients required removal of fibre particles from their eye by a surgeon.
- Health professionals are reminded to examine the pack and its contents before use.
The Custom-Pak Ophthalmic Surgery Procedure Pack is a surgical tray consisting of single-use devices and accessories for specific ophthalmic procedures such as cataract surgery. It is regulated as a class IV medical device (highest risk class). Its licence was first issued in Canada in October 1999. The pack is customized for each type of procedure to meet the specific needs of the surgeon and the facility.1 The contents of the pack are grouped based on their intended use and include components such as procedure cassettes and accessories, barrier products, plastics, gloves, knives, sutures, absorbing products, self-adhesive products, eye protection products and electrosurgical devices. Once assembled, the packs are placed in plastic pouches with a content label and sealed. The pouches are sterilized and then placed in cardboard shipping boxes.
As of Apr. 30, 2011, Health Canada received 28 reports of incidents suspected of being associated with the contamination of the surgical pack with lint, fibre or particles. The foreign bodies were either discovered in the packs or found by the surgeon during surgery or the postoperative examination of the patient's eye. In 14 cases, the reporter described that the foreign body was removed by the surgeon. In 10 of these cases, a second surgery was required to do this, and in 3 cases the surgeon removed the foreign body from the eye during the initial surgery (information not specified in 1 report). In several of the reports, physicians expressed a concern for the potential risk of infection. Also, in many of these reports, the exact source of the foreign body could not be conclusively determined.
Some of the reports described that the manufacturer had identified the particles as cotton, polyethylene, paper, polyurethane foam, polyester fibre, polystyrene, poly 3-methylcaprolactam and cardboard. It was also reported that the particles may have originated from the components of the surgical pack itself. The cardboard particles may have entered the product at the supplier's, in the Custom-Pak warehouse or during the assembly process.
Any foreign substance has the potential to induce an inflammatory response.2 In cases where a foreign body, such as a cotton fibre, has been inadvertently implanted inside the eye during surgery and left there, the evidence relating to the long-term clinical consequences is limited.3 A foreign body that penetrates the eye as a result of an ocular trauma can cause infection, among other complications. In such cases, prompt diagnosis and appropriate treatment, including antimicrobial therapy, can help prevent the risk of infection and endophthalmitis.4
Health professionals are reminded to examine the Custom-Pak Ophthalmic Surgery Procedure Pack and its contents before use. Health Canada continues to monitor adverse incidents suspected of being associated with this product and is working with the manufacturer to update the product label.
Ilhemme Djelouah, RPh, BScPhm, DIS Medical Biology (University of Paris V), Health Canada
- Cataract product catalog: global version. Hünenberg (Switzerland): Alcon; 2008-2009. (accessed 2011 June 27). (PDF Version - 5.3 K)
- Sari A, Basterzi Y, Karabacak T, et al. The potential of microscopic sterile sponge particles to induce foreign body reaction. Int Wound J 2006;3(4):363-8. [PubMed]
- Yuen HKL, Lam RF, Kwong YYY, et al. Retained presumed intraocular cotton fiber after cataract operation: long-term follow-up with in vivo confocal microscopy. J Cataract Refractive Surg 2005;31(8):1582-7. [PubMed]
- Colby K. Corneal abrasions and foreign bodies. In: Porter RS, Kaplan JL, editors. The Merck manual online. 18th ed. Whitehouse Station (NJ): Merck Sharp & Dohme Corp. (accessed 2011 July 19).
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.
Dental/surgical rotary handpieces and patient burns
Rotary handpieces used in dental and surgical procedures consist primarily of an engine and a chuck mechanism that secures burs (drill bits) into place. Handpieces may be classified as either pneumatic (use of a turbine driven by compressed air) or electric (powered by an electric motor).1 These devices are used to cut, shape, drill, abrade, burnish, finish and polish tissue and restorative materials. In Canada, surgical rotary handpieces are typically regulated as class II medical devices (IV being the highest risk class).
Health Canada received a report of a patient who experienced a burn to the cheek area during restorative work on an upper tooth with a dental handpiece. As a result, there was pain and swelling in the area and the patient was prescribed an analgesic. After 2 weeks, some scarring was noted at the burn site. Post-incident analysis by the manufacturer revealed that the handpiece in question had worn bearings and had been inadequately maintained overall. This possibly contributed to increased internal friction and heat production. Furthermore, the reported use of the back of the head of the handpiece as a cheek retractor, and the presence of a dent along the back cap edge of the device, may have also affected the operation of the handpiece and contributed to the device overheating. Health Canada has received similar reports of patient burns involving different handpiece models from several device manufacturers.
Health Canada encourages the reporting of patient burns and other adverse incidents suspected of being associated with the use of dental or surgical handpieces to the Health Products and Food Branch Inspectorate through the toll free hotline (1-800-267-9675).
- Little D. Handpieces and burs: the cutting edge. Chesterland (OH): Academy of Dental Therapeutics and Stomatology; 2009. (accessed 2011 July 12).
CARN's 20th anniversary
Celebrating a milestone anniversary is an opportunity to remember what has been accomplished in past years and to look ahead to new challenges. The Canadian Adverse Reaction Newsletter (CARN) was first published in 1991. Although its appearance and Editorial Team have changed over the last 20 years, its primary goal remains the same: to be a reliable source of information on adverse reactions (ARs) suspected of being associated with health products in Canada.
CARN is an example of an early-stage risk communication tool, one of many risk communication vehicles that Health Canada uses to issue health product safety information.1 It features articles and data related to serious or unexpected adverse reactions (ARs) reported to Health Canada by industry, health professionals and consumers. Spontaneous AR reports continue to be an important component in monitoring the safety of health products.2 These reports provide the backbone of CARN and make it relevant to the reader. Its intent is not only to raise awareness, but also to stimulate reporting of similar ARs by health professionals and consumers.
The information published in CARN about Canadian AR reports can enhance the global understanding of a health product safety issue. For example, in a recent review of the interaction between rosiglitazone and fenofibrate published in Endocrine Practice,3 an AR report from the July 2005 issue of CARN4 was included as evidence in the clinical understanding of the interaction. In April 2011, CARN published an update on rosiglitazone-fenofibrate interactions, with details of the most recent Canadian cases reported to Health Canada.5 This is not the only time CARN has been cited in the literature. The Editorial Team conducted an analysis of the number of citations to CARN in the scientific literature as an indirect measure of its impact. As of Mar. 31, 2011, there have been 140 citations in more than 70 journals internationally.
The Editorial Team would like to take this opportunity to thank its readers for their continued interest.
CARN Editorial Team
After 20 years, CARN will be undergoing changes to its Editorial Team. I am pleased to introduce the new Editor-in-Chief, Patricia Carruthers-Czyzewski. I have had the privilege of serving as Editor-in-Chief since 1996. I have witnessed first-hand how AR reports published in CARN contributed to the understanding of emerging safety issues. This underscores the vital role you play in reporting ARs that you witness in your professional practice. It also highlights the importance of promoting a reporting culture where health professionals, consumers and industry have a shared responsibility. I am convinced that CARN will continue to disseminate this valuable information. The challenge for CARN over the next decade will be to leverage the reach of new tools such as social media to further its goal of prompting AR reporting and increasing awareness.
Ann Sztuke-Fournier, BPharm, Former Editor-in-Chief
- Description of current risk communication documents for marketed health products for human use -- guidance document. Health Canada; 2008. (accessed 2011 June 27).
- Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health 2008;98(8):1366-71. [PubMed]
- Schwing W, Hustak L, Taylor HC. Paradoxical severe decrease in high-density lipoprotein cholesterol due to rosiglitazone-fenofibrate interaction. Endocr Pract 2010;16(3):382-8. [PubMed]
- Willcox D. Rosiglitazone (Avandia): decreased high-density lipoprotein cholesterol levels. Can Advers Reaction Newsl 2005;15(3):2. (accessed 2011 July 18).
- Tremblay P. Rosiglitazone-fenofibrate interaction: severe paradoxical decreased high-density lipoprotein cholesterol levels. Can Advers Reaction Newsl 2011;21(2):2. (accessed 2011 June 27).
Did you know?
Medical devices and incidents
This issue of the Canadian Adverse Reaction Newsletter is dedicated to incidents with medical devices.
The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. In Canada, all medical devices are categorized into 4 classes based on the level of risk associated with their use.
Class I: Lowest risk (e.g., reusable surgical scalpel, bandages, culture media)
Class II: Low risk (e.g., contact lenses, epidural catheters, pregnancy test kits)
Class III: Moderate risk (e.g., orthopedic implants, glucose monitors, dental implants)
Class IV: High risk (e.g., HIV test kits, pacemakers, angioplasty catheters)
Health Canada encourages healthcare professionals and the general public to report incidents suspected of being associated with medical devices to the Health Products and Food Branch Inspectorate through the toll free hotline (1-800-267-9675). Additional information on incident reporting can be found on the Health Canada Web site.
Quarterly Summary of health professional and consumer advisories
(posted on Health Canada's Web site: May 21, 2011 - August 22, 2011)
|Date of issuance. This date may differ from the posting date on Health Canada's Web site.|
|Aug 17||Products from Ben Venue Laboratories Inc.||Potential supply shortage|
|Aug 4||Sandoz products||Possible fading of the expiry date and lot number|
|Aug 4||Propecia & Proscar (finasteride)||Potential rare risk of breast cancer in men|
|July 22||Centrum Materna Prenatal Multivitamins||Unidentified capsules found in one bottle|
|July 21 & 29, Aug 4||Multaq (dronedarone)||Potential of an increased risk of cardiovascular events|
|July 20||Calcium Gluconate Injection 10%||Important information concerning the presence of aluminum|
|July 20||Metoclopramide||Stronger warnings on risk of abnormal muscle movements|
|July 13||Procter & Gamble mouthwash||Recall: possible microbial contamination|
|July 8||Valproate products||Risks to children when taken by mothers during pregnancy|
|July 4||Man Up Now||Removed from sale due to undeclared sildenafil|
|June 27||Champix (varenicline tartrate)||Potential risk of heart problems in patients with heart disease|
|June 21||Level 1 Normothermic I.V. Fluid Administration Sets||Withdrawal of products equipped with F-50 gas vent filter assembly|
|June 21||Cialis||Seizure of counterfeit Cialis in the Greater Toronto Area|
|June 17||Actos (pioglitazone)||Potential risk of bladder cancer|
|June 15||Antipsychotic drugs||Labelling update: risk of abnormal muscle movements and withdrawal symptoms in newborns exposed during pregnancy|
|June 14, July 6 & 25||Unauthorized products||Removed from sale at Burnaby and Richmond stores due to possible serious health risks|
|June 7||Junior (160 mg) and children's (80 mg) strength acetaminophen tablets||Recall: faulty child resistant packaging|
|June 7||Yaz and Yasmin (drospirenone-containing oral contraceptives)||Potential for an increased risk of venous thromboembolism|
|June 3||Docusate sodium capsules USP, 100mg||Recall of lot 31040225: possible bacterial contamination|
|June 2 & 7||Rituxan (rituximab)||Fatal infusion related reactions in patients with rheumatoid arthritis|
|May 3||Boston Scientific devices||Risk of infection with non-sterile devices stolen|
|May 21 to Aug 22||Foreign products||9 Foreign Product Alerts (FPAs) were posted on the Health Canada Web site during this period; FPAs are available online to the Media Room or upon request|
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Canadian Adverse Reaction Newsletter
Marketed Health Products Directorate
Address Locator 0701D
Ottawa ON K1A 0K9
Ann Sztuke-Fournier, BPharm (Former Editor-in-Chief)
Patricia Carruthers-Czyzewski, BScPhm, MSc (Editor-in-Chief)
Jared Cousins, BSP
Christianne Scott, BPharm, MBA
Hoa Ly, BSc
Emir Al-Khalili, BA, BScPhm
Sophie Bourbonnais, BScPht
We thank the following members of the Expert Advisory Committee on the Vigilance of Health Products for their review of material for this issue: Colleen J. Metge, BSc(Pharm), PhD and Sylvia Hyland, RPh, BScPhm, MHSc. We also thank Benjamin Pearson and Aleksandar Brezar, students in Health Sciences and Biopharmaceutical Sciences, respectively, for their participation in the production of the newsletter.
Your comments are important to us. Let us know what you think.
Canadian Adverse Reaction Newsletter (CARN) Editorial Team.
Reporting Adverse Reactions
Canada Vigilance Program
© 2011 Her Majesty the Queen in Right of Canada. 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.
Due to time constraints relating to the production of this publication, information published may not reflect the most current information.
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