Unauthorized drug (URX Bombshell) being sold online may pose serious health risks

Starting date:

April 19, 2016

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Unauthorized products, Product Safety

Audience:

General Public

Identification number:

RA-57974

• Issue
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Health Canada is advising Canadians that an unauthorized drug, URX Bombshell, labelled to contain prescription drug substances (yohimbine and rauwolfia), was being sold on Kijiji and at DiscountSupplementsCo.com. These drugs may pose serious health risks.  Products containing prescription drug ingredients should only be taken under the supervision of a health professional because they are used to treat specific diseases, and may cause serious side effects.

What you should do

• Consult your healthcare professional if you have used URX Bombshell and have health concerns.
• Read the product label to verify that health products have been authorized for sale by Health Canada have an eight-digit DIN, a DIN-HM or a NPN.
• Verify that your health products have been authorized for sale by searching the Drug Product Database, Medical Devices Active Licence Listing (MDALL) and the Licensed Natural Health Product Database.
• Report any adverse events to Health Canada
• Report complaints about health products to Health Canada by calling toll-free 1-800-267-9675, or complete an online complaint form.

Who is affected

Consumers who have purchased or used URX Bombshell.

Background

URX Bombshell has not been approved by Health Canada. This means that it has not been assessed for safety, effectiveness and quality. As a result, it may contain ingredients not listed on the label, other additives and/or contaminated ingredients or other ingredients that may interact with other medications and foods. In addition, it may lack the active ingredients Canadians would expect it to contain to help maintain and improve their health. As a result these products could cause serious health effects.

Rauwolfia is listed as a prescription drug and contains reserpine which has been used for the treatment of high blood pressure (hypertension). It is permitted in very low concentration in some homeopathic preparations. However, rauwolfia is of particular concern when used without health professional oversight by persons with a heart condition or psychiatric disorder where patient history must be carefully considered.

As an example, the use of rauwolfia by individuals with a history of depression may exacerbate their condition. Tiredness, sleepiness, depression, nasal obstruction and breathlessness are some of the more common side effects noted with the use of rauwolfia. Rauwolfia should not be used by children, pregnant or nursing women.

Yohimbine is a prescription drug ingredient. The use of drugs containing yohimbine (either as yohimbine hydrochloride or yohimbe bark extract) may result in serious adverse reactions, particularly in people with high blood pressure, heart, kidney or liver disease. Side effects associated with yohimbine include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, pregnant or nursing women.

Report health or safety concerns

• Call Health Canada toll-free at 1-866-234-2345.
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Should additional retailers of URX Bombshell be identified, Health Canada will take appropriate action and inform Canadians.

Images

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