Public advisory - Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone tablets recalled due to data integrity concerns

OTTAWA, ON, June 7, 2024 /CNW/ -

Summary

• Products: All lots of Accel-Ondansetron ODT (4 mg and 8 mg tablets); Mint-Betahistine (8 mg, 16 mg and 24 mg tablets); PMS-Pirfenidone (267 mg and 801 mg tablets)
• Issue: Health products – Product safety
• What to do: Return the affected products to your local pharmacy for a replacement, and for proper disposal. If you are unsure whether your product is affected, check with your pharmacy. Consult a health care professional if you have used the affected product and you have health concerns.

Affected products

Product	DIN	Lot	Expiry
Accel-Ondansetron ODT 4 mg tablets	02535319	CDX00123	09-2026
Accel-Ondansetron ODT 8 mg tablets	02535327	CEA00123	09-2026
Mint-Betahistine 8 mg tablets	02538121	2330704 2430152	07-2025  01-2026
Mint-Betahistine 16 mg tablets	02538148	2330705  2330945  2330946  2330947  2430153	07-2025  10-2025  10-2025  10-2025  01-2026
Mint-Betahistine 24 mg tablets	02538156	2330706A  2430154	07-2025  01-2026
PMS-Pirfenidone 267 mg tablets	02531526	E0800A E0800C E0800E E0800F	11-2024
PMS-Pirfenidone 801 mg tablets	02531534	E0802A  E0802C	12-2024

Issue

Three companies (Accel Pharma Inc., Mint Pharmaceuticals Inc., and Pharmascience Inc.) are recalling all lots listed in the Affected Products table (above) due to concerns about the integrity of tests that are used to show that their generic prescription drugs work the same as brand-name versions.

Health Canada's authorization of the affected products relied on the bioequivalence test data. Bioequivalence data is used to demonstrate that generic drugs are equivalent to their brand-name counterparts.

The bioequivalence tests were conducted by Synapse Labs Pvt. Ltd., a contract research organization in Pune, Maharashtra, India. An inspection by a member of the European Medicines Agency, a trusted regulatory partner, found that data produced by Synapse Labs can no longer be relied upon to show this bioequivalence. As a result, the affected products can no longer be considered safe and effective. At Health Canada's request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective.

Health Canada is monitoring the effectiveness of the recalls and will take appropriate and timely action if any new health risks are identified.

What you should do

• Return the affected products to your local pharmacy for a replacement, and for proper disposal. If you are unsure whether your product is affected, check with your pharmacy.
• Consult a health care professional if you have used the affected product and you have health concerns.
• Report any health product-related side effects or complaints to Health Canada.
• Contact the companies if you have questions about their recall:
• Accel Pharma Inc., by contacting Betty Cory at Accel Quality Assurance by calling [phone], or by email at [email protected]
• Mint Pharmaceuticals Inc., by contacting Olenka Crewe at Mint Pharmaceuticals Inc. Scientific Affairs by calling (416)-803-9151, or by email at [email protected]
• Pharmascience Inc. by calling, toll-free, at 1-800-340-9735, or by email at [email protected]

Background

Accel-Ondansetron ODT is used to prevent nausea and vomiting related to chemotherapy in patients 4 years of age and older, radiotherapy in adults 18 years of age and older, and after surgery in adults 18 to 64 years of age. Receiving too little ondansetron could lead to reduced efficacy (i.e., increased risk of nausea and vomiting). Severe cases can lead to dehydration, loss of appetite, malnutrition, electrolyte imbalances, weight loss and fatigue. If used after surgery, severe nausea and vomiting might lead to complications such as wound opening and infection. Receiving too much ondansetron could lead to serotonin syndrome, a serious drug reaction caused by medications that build up high levels of serotonin in the body. Symptoms of serotonin syndrome can be mild, such as shivering and diarrhea, or severe, such as seizures, muscle rigidity and fever, and changes in heart rate and blood pressure. Too much ondansetron can affect heart rhythm and lead to sudden cardiac arrest. The heart-related effects and serotonin syndrome can both be fatal if untreated.

Mint-Betahistine is used for reducing the episodes of recurrent vertigo (dizziness) associated with Ménière's disease in adults 18 years of age and older. Receiving too little betahistine could lead to reduced efficacy and inadequate disease treatment. Unexpected vertigo episodes can lead to accidents and injuries, which can have serious consequences. Receiving too much betahistine could lead to headaches, nausea, and upset stomach.

PMS-Pirfenidone is used to treat a serious, long-term lung disease known as idiopathic pulmonary fibrosis (IPF) in adults 18 years of age and older. Receiving too little pirfenidone could lead to reduced efficacy and inadequate disease treatment, resulting in worsening symptoms and disease progression. Receiving too much pirfenidone can lead to nausea, diarrhea, upset stomach, abdominal pain, decreased appetite, dizziness, headache, photosensitivity (sun) reaction and rash. It can also lead to drug-induced liver injury. Signs of liver injury include yellow skin or eyes (jaundice).

Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]