It all started with a bad taste of fish. Patients consuming Topaal®, a antacid medication which protects the esophagus from gastric reflux, complained overwhelmingly in 2014 about the unpleasant taste and smell they felt when swallowing the tablets. The National Medicines and Health Products Safety Agency (ANSM) then carried out the investigation, which led to the withdrawal from sale of this medicine.
Lack of hygiene during manufacturing
The cause of this ban comes from observations of non-compliance with hygiene rules during the manufacturing processes of Topaal®. This drug, marketed by the French pharmaceutical laboratory Pierre Fabre, is encapsulated on the site of the company Cargill France, in Lannilis, in Finistère. “The manufacturing conditions on the Lannilis site present risks of making contaminated or deteriorated raw materials available.“thus indicated the ANSM. The main component of Topaal® is a derivative of brown algae, alginic acid. The fault comes from the processes of cleaning, demineralization and grinding of algae.
Precautionary principle
The first analyzes did not reveal any risk for the patients but, under the precautionary principle, the activity of the plant was suspended on September 25, 2015, and Topaal® withdrawn from sale on October 5. This ban is valid for at least one year, while the manufacturing site adopts the standards in force.
For any information and to adapt their treatment, the ANSM advises people consuming Topaal® to consult their attending physician.
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