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Monday October  5, 12:31

France: A Drug Against Gastric Reflux Will Be Withdrawn From Sale

France: A drug Topaal against gastric reflux will be withdrawn from sale.
France: A drug Topaal against gastric reflux will be withdrawn from sale.

The Topaal, a medication against gastroesophageal reflux in adults, will be withdrawn from sale on behalf of the precautionary principle, said Saturday the French National Agency of Drug Safety (MSNA).

"The end of commercialization of Topaal will be effective from next Monday," said a spokeswoman ANSM to Agence France-Presse. This decision follows an investigation last July by the MSNA that resulted in the suspension of its activities, including the manufacture of the active ingredients of Topaal, alginic acid.

The investigation was launched after "nine complaints of patients for quality defect of a drug on a bad taste and a fishy odor". The ANSM decision published in the Official Journal of 1 October. One patient has reported a "rash" after use of "active substance" said the MSNA.

The survey revealed a particularly "lack of cleanliness of the manufacturing environment", a "particularly degraded condition of the equipment manufacturing" several workshops and "deficiencies" in the quality management system.

Because of "suspicion of danger caused by the use of these raw materials," the agency found it necessary "to withdraw batches of drugs, medical devices or cosmetics with". It also decided to suspend for a period not exceeding one year, "the production, packaging, marketing, distribution, export, and use of raw materials produced by the company Cargill France"



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