What is MedEffect Canada?

MedEffect Canada provides consumers, patients, and health professionals with easy access to: Report an adverse reaction or side effect; Obtain new safety information on drugs and other health products; and. Learn and better understand the importance of reporting side effects.

Is Vyvanse in Canada?

Takeda developed the VYVANSE Patient Assistance Program for Canadian patients requiring reimbursem*nt support. The Program is available to all eligible Canadians . For more information on the Vyvanse assistance program please call 1-855-442-9395 or email vyvanse_support@smartsti.com.

What is Vanessa's law in Canada?

In addition to mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs), Vanessa's Law empowers Health Canada to order recalls, impose tougher penalties for unsafe products, and compel drug companies to revise labels or do further testing on products .

What is the regulatory agency for medicines in Canada?

Canada's Drug Agency is a pan-Canadian health organization. Created and funded by Canada's federal, provincial, and territorial governments, we're responsible for driving better coordination, alignment, and public value within Canada's drug and health technology landscape.

What is the closest drug to Vyvanse?

Stimulant ADHD medications are the most similar to Vyvanse and may be considered the “best” alternatives. They include Vyvanse, Concerta, Ritalin, and Adderall. They work by increasing dopamine and norepinephrine in the brain to increase mood, energy, and attention.

Why is Vyvanse safer than Adderall?

These drugs are considered to be potential drugs of misuse; however, because Vyvanse is a prodrug and takes longer to metabolize in the system than Adderall, it is considered to have a lower risk of misuse.

What is the equivalent of Vyvanse to Adderall?

The active ingredient in Vyvanse is lisdexamfetamine. Lisdexamfetamine is an inactive drug that the body breaks down into dextroamphetamine in the bloodstream. Dextroamphetamine is one of the same active ingredients that Adderall contains . Vyvanse is available in a capsule or in a chewable form.

Are ADHD meds available in Canada?

f Vyvanse 70 mg is an off-label dosage for ADHD treatment in Canada . g To augment Adderall XR or Vyvanse, short-acting and intermediate-acting dextro-amphetamine products can be used. To augment Biphentin or Concerta, short-acting methylphenidate products can be used.

How can I save on Vyvanse in Canada?

The innoviCares card is a free prescription savings card available to all Canadian residents , and is funded by participating pharmaceutical manufacturers. Present your innoviCares card at your pharmacy and ask for the brand-name medication. Your card will automatically cover a portion of the cost of the original brand.

Can I buy prescription medicine from Canada to the US?

For the most part, individuals aren't allowed to import prescriptions, though many people order medications by mail or travel across the U.S.-Canada border to make more affordable purchases. Under limited circ*mstances, the FDA allows people in the U.S. to buy prescription medications from Canada for personal use .

Is Adderall a controlled substance in Canada?

Adderall XR® (mixed amphetamine salts) Adderall XR® is a controlled drug , made up of a combination of different AMP salts, predominantly dextro-amphetamine (DEX).

Health Product InfoWatch: May 2024 (2024)

Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 240000

Published: 2024-05-30

Monthly recap of health product safety information
- Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL)
- JAMP Guanfacine XR
- Neulasta (pegfilgrastim)
- PMS-Duloxetine
- Unauthorized Health Products
New health product safety information
- Product monograph updates
  - Losec (omeprazole) and Losec Mups (omeprazole magnesium)
  - Vyvanse (lisdexamfetamine dimesylate)
Scope
Reporting Adverse Reactions
Helpful links
Contact us
References

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviewspublished in April 2024 by Health Canada.

Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL)

Due to a shortage of Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL) in Canada and given the medical necessity of this product, Health Canada has permitted the exceptional, temporary importation and sale of Italian-authorized Cisatracurio Hikma 2 mg/mL with Italian-only labels. Healthcare professionals should be aware that there are important differences between the Italian-authorized Cisatracurio Hikma 2 mg/mL and the Canadian-authorized Cisatracurium Omega products. Refer to the Canadian product monograph for Cisatracurium Omega Single Dose, by Omega Laboratories Limited, for information on proper use.

Health Product Risk Communication: Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL)

JAMP Guanfacine XR

JAMP Pharma Corporation recalled one lot of JAMP Guanfacine extended release (XR) 4 mg tablets as some tablets may have been contaminated with foreign matter during manufacturing. The foreign matter, which is composed of a combination of cellulose, lubricant oil, calcium, and/or iron oxide, causes brown or amber-coloured staining on the tablet. These substances are not expected to pose any serious health risks; however, it is recommended that the medication be replaced if stains are identified.

Advisory: JAMP Guanfacine XR

Neulasta (pegfilgrastim)

This safety review evaluated the risks of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of Neulasta. Health Canada's review did not find sufficient evidence to support a link. Health Canada will continue to monitor the safety of Neulasta.

Summary Safety Review: Neulasta (pegfilgrastim)

PMS-Duloxetine

Affected lots of PMS-Duloxetine 30 mg and 60 mg capsules have been recalled as they exceeded the interim acceptable intake limit forN-nitroso-duloxetine (NDLX).

Type 1 drug recall: PMS-Duloxetine 30 mg
Type 1 drug recall: PMS-Duloxetine 60 mg

Unauthorized Health Products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

Advisory: Fake Viagra seized from Jug City store in Scarborough, ON
Advisory: Unauthorized health products seized from Vanette Keast Health Consulting in Red Deer, Alberta
Advisory: Unauthorized sexual enhancement products

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monographs, have been included for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.

Losec (omeprazole) and Losec Mups (omeprazole magnesium)

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions), and Patient Medication Information sections of the Canadian product monographs for Losec and Losec Mups have been updated with the risk of acute tubulointerstitial nephritis.

Key messages for healthcare professionals:^{Footnote 1} ^{Footnote 2}

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking omeprazole and may occur at any point during omeprazole therapy.
Acute TIN can progress to renal failure.
Omeprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated.
Patients should be advised to consult their healthcare professional if they experience symptoms suggestive of inflammation of the kidney (decreased volume of urine, blood in the urine, fever, rash, joint stiffness).

Health Canada, in collaboration with manufacturers, will be working to include similar information about the risk of acute TIN in the Canadian product monographs for all authorized proton pump inhibitors in Canada.

Vyvanse (lisdexamfetamine dimesylate)

The Warnings and Precautions and Adverse Reactions (Post-Market Adverse Reactions) sections of the Canadian product monograph for Vyvanse have been updated with the risk of QTc prolongation.

Key messages for healthcare professionals:^{Footnote 3}

Lisdexamfetamine dimesylate has been shown to prolong the QTc interval in some patients.
Vyvanse should be used with caution in patients with a prolonged QTc interval, those treated with drugs affecting the QTc interval, or those with relevant pre-existing cardiac disease or electrolyte disturbances.
As a reminder, Vyvanse is contraindicated in patients with symptomatic cardiovascular disease and also in patients with moderate to severe hypertension.

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
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Contact us

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

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9

References

Footnote 1

Losec (omeprazole delayed release capsules) [product monograph]. Greifswald (Germany): Cheplapharm Arzneimittel GmbH, 2023.

Return to footnote 1 referrer

Footnote 2

Losec Mups (omeprazole magnesium delayed release tablets) [product monograph]. Greifswald (Germany): Cheplapharm Arzneimittel GmbH, 2023.

Return to footnote 2 referrer

Footnote 3

Vyvanse (lisdexamfetamine dimesylate) [product monograph]. Toronto (ON): Takeda Canada Inc., 2024.

Return to footnote 3 referrer