Health Product InfoWatch - January 2015

ISSN 2368-8025
Pub. no 140412

Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

Contents

• Announcement
• Monthly recap
• New information
  • Review article: Cisplatin and venous thromboembolism

Health products mentioned in this issue

Pharmaceuticals and Biologics

• Cisplatin
• Hydroxyethyl Starch Solutions
• Yervoy (ipilimumab)

Medical Devices

• Laparoscopic Electric Morcellators

Natural Health Products

• Forta for Men
  Herberex
  Hydro-Lean
  Jetfuel Superburn
  RAPHA Vitamin B1, Gra-MaxX Gold, Rapha Diet

Other

• Foreign Products
• Quarantined Health Products
• Seized Health Products

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions
Canada Vigilance Program
Phone: 1-866-234-2345
Fax: 1-866-678-6789

For more information on how to report an adverse reaction, visit the Reporting Adverse Reactions to Drugs and Other Health Products page.

Announcement

New Format! New Information! New Name!

The Canadian Adverse Reaction Newsletter (CARN) is taking on a new format, look and name: Health Product InfoWatch.

The CARN is taking on a new look and name in order to meet the changing information needs of healthcare professionals and the public.

The Health Product InfoWatch will be published monthly in an easy to read format that includes a monthly recap of health product advisories and summary safety reviews, as well as a growing selection of new health product safety information.

If you are currently subscribed to CARN, you will automatically be subscribed to the Health Product InfoWatch. If you want to subscribe to Health Product InfoWatch, you can do so directly on the Stay Informed - MedEffect Canada page.

Monthly recap of health product safety information

The following is a list of health product advisories as well as summaries of completed safety reviews published in December 2014 by Health Canada.

Additional products seized from two Calgary stores

Further to a recent advisory, Health Canada has identified additional products seized from two Samson’s Supplements stores in Calgary that pose a risk to health. The labels on these products indicate that they contain yohimbine or a combination of ephedrine and caffeine. These products are promoted for body building purposes, including for weight loss and increased energy, or for sexual enhancement.

Information Update

Forta for Men

One lot of the product “Forta for Men” (NPN 80045132) is being recalled after Health Canada testing confirmed it contains an undeclared drug: homosildenafil. Homosildenafil is similar to the prescription drug sildenafil.

Advisory

Health products quarantined from two sites in India

At Health Canada’s request, Canadian importers have agreed to quarantine health products from the following two India-based sites due to data integrity concerns: Dr. Reddy’s Laboratories in Srikakulam, India, and IPCA Laboratories in Pithampur, India. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk.

Information Update

Herberex

The sexual enhancement product “Herberex” (NPN 80041180) is being recalled after Health Canada testing confirmed it contains an undeclared drug: tadalafil. Promoted as a natural sex enhancer for men and women, this product may pose serious health risks.

Advisory

Hydro-Lean weight loss product

The unauthorized product “Hydro-Lean” was seized from two Calgary stores because the label indicates it contains a combination of ephedrine and caffeine. Hydro-Lean is promoted for body building purposes, including for weight loss and increased energy.

Advisory

Hydroxyethyl Starch Solutions

This safety review evaluated the currently available information regarding the possible increased risk of kidney injury and death associated with hydroxyethyl starch (HES) solutions when compared to alternative treatments. Health Canada found that there is an increased risk of kidney injury and death in critically ill patients, including patients with sepsis, who are treated with HES solutions. Health Canada has communicated on this risk to both patients and healthcare professionals and has worked with the manufacturer to update the prescribing information.

Summary Safety Review

Jetfuel Superburn

“Jetfuel Superburn” is being recalled after Health Canada tests confirmed it contains two undeclared amphetamine-like drug substances that pose serious health risks (beta-methylphenethylamine and phenylpropylmethylamine). Jetfuel Superburn is promoted for body building purposes, including for weight loss and increased energy.

Advisory

Laparoscopic Electric Morcellators

Health Canada has reviewed the relevant clinical and scientific data pertaining to the possible spread and upstaging of occult uterine cancer with the use of electric morcellators during laparoscopic hysterectomy and uterine myomectomy. Based on the results of its review, Health Canada will be working with device manufacturers to revise the instructions for use.

Notice to Hospitals

RAPHA Vitamin B1, Gra-MaxX Gold, Rapha Diet

Further to a previous communication, Health Canada testing has found three additional health products removed from sale at ShopForYou in Vancouver, B.C., with undeclared ingredients. The undeclared substances include sibutramine, desmethyl sibutramine, N-ethyl tadalafil, amphetamine and methamphetamine.

Advisory

Yervoy (ipilimumab)

This safety review evaluated the currently available information regarding the possible risk of posterior reversible encephalopathy syndrome (PRES) with the use of Yervoy (ipilimumab). It has been determined that available information is too limited to accurately assess the risk of PRES. Health Canada has asked the manufacturer of Yervoy to perform continued surveillance of this adverse event with Periodic Safety Update Reports.

Summary Safety Review

Five Foreign Product Alerts (FPAs) were issued by Health Canada. FPAs may be consulted by searching the Recalls and Safety Alerts Database.

For a list of health product advisories published between Oct. 1 – Nov. 30, 2014, please see the summary of health professional and consumer advisories.

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Review article

Cisplatin and venous thromboembolism

Cisplatin, a platinum agent, is a DNA-modifying anticancer drug that has been marketed in Canada since 1979. It is indicated for the treatment of genitourinary cancers including cancers of the testis, bladder and ovary.^{Footnote 1Footnote 2Footnote 3Footnote 4Footnote 5}

Venous thromboembolism includes both deep vein thrombosis (DVT) and pulmonary embolism (PE).^{Footnote 6} DVT results from blood clot formation within large veins, usually in the legs. PE results from DVTs that have broken off and traveled to pulmonary arterial circulation. A variety of medical conditions (including cancer), medications, and lifestyle factors are known to be associated with venous thromboembolic events (VTEs).

The scientific literature suggests a potential association between cisplatin and VTEs. A systematic review and meta-analysis of randomized controlled trials was conducted to evaluate the incidence and risk of VTEs with cisplatin-based chemotherapy.^{Footnote 7} Thirty-eight randomized controlled trials with over 8000 patients with various advanced solid tumours were included in the review. The results reported a 1.67-fold increase in the risk of VTEs with cisplatin compared to non-cisplatin-based chemotherapy. Further subgroup analysis reported that patients receiving a weekly equivalent cisplatin dose greater than 30 mg/m² were at higher risk of VTEs. This study concluded that cisplatin is associated with a significant increase in the risk of VTEs in patients with advanced solid tumours when compared to non-cisplatin-based chemotherapy.

A large retrospective analysis was conducted with 932 patients treated with cisplatin-based chemotherapy for any type of cancer in a single institution.^{Footnote 8} This study observed a high incidence of thromboembolic events in these patients, with the majority of events occurring early in the course of treatment. Of the 932 patients, 18.1% developed a thromboembolic event within 4 weeks of their last cisplatin dose. The majority of events were DVTs, followed by PEs, with some patients experiencing arterial thrombosis or a combination of thromboembolic events.

As of Aug. 31, 2014, Health Canada received 21 reports of DVT and/or PE suspected of being associated with cisplatin. Many of the reports lacked important information including patient information, dosing information, and duration of exposure. In several cases, patients were reported as having conditions, as well as receiving concomitant drugs, known to be associated with VTEs.

Healthcare professionals should be aware of the potential association between cisplatin and VTEs and are encouraged to report to Health Canada any suspected cases. Information such as treatment duration or exposure, dosing, relevant concomitant medical conditions and medications and other patient information are important to include when reporting adverse reactions. This information may help to further evaluate adverse reactions suspected of being associated with cisplatin-based therapies.

References

Helpful links

• MedEffect™ Canada
• Recalls and Safety Alerts Database
• Summary Safety Reviews
• Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Canadian Drug Shortage Database

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at InfoWatch_InfoVigilance@hc-sc.gc.ca

Health Canada
Marketed Health Products Directorate
Address Locator 0701D
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

© 2015 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.

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.

Due to time constraints relating to the production of this publication, information published may not reflect the most current information.

Summary of health professional and consumer advisories