Post by emonseo10 on Jan 11, 2024 5:53:21 GMT -5
The Spanish Agency for Medicines and Health Products (Aemps) has ordered the prohibition of marketing and the withdrawal of all units of the Liver Refresh product, which is sold as a food supplement through several websites. In a statement, it explains that its placing on the market has not been notified to the competent authorities, as provided for in current regulations. And, according to the product labeling, it contains pancreatin , a pharmacologically active substance, which, according to the Aemps, "gives it the status of a medicine."
Since it was not evaluated and authorized by the Aemps before being marketed, this body has decided to withdraw it from the market, but also because of the risks it entails. The Aemps explains that pancreatin is a Professional Person Email List concentrate of pancreatic enzymes that catalyze the hydrolysis of fats - through lipase -, proteins - proteases - and carbohydrates - amylase - and has a digestive action.
It is indicated in the treatment of exocrine pancreatic insufficiency, such as in patients with pancreatitis, cystic fibrosis, pancreatectomy, postoperative gastrointestinal surgery such as Bilroth I or II or bile duct obstructions of a neoplastic nature. Its dose must be adjusted depending on the severity of the disease, the control of the steatorrhea it produces and the maintenance of a satisfactory nutritional status, points out the Aemps, which adds that its consumption may cause cases of hypersensitivity to these exogenous proteins.
Furthermore, in high doses in patients with cystic fibrosis it has been associated with the appearance of intestinal and colonic strictures, and with colitis. Its use is linked to adverse reactions of a digestive nature , intestinal obstruction, dermatological, allergic and metabolic, but pancreatin can also cause irritation of the perioral skin and oral mucosa if it is retained in the mouth.
Therefore, "considering the aforementioned risks, as well as the fact that the aforementioned product (manufactured by the American company Now Foods) has not been subject to evaluation and authorization prior to marketing by the Aemps", it has been decided to withdraw the product market.
Since it was not evaluated and authorized by the Aemps before being marketed, this body has decided to withdraw it from the market, but also because of the risks it entails. The Aemps explains that pancreatin is a Professional Person Email List concentrate of pancreatic enzymes that catalyze the hydrolysis of fats - through lipase -, proteins - proteases - and carbohydrates - amylase - and has a digestive action.
It is indicated in the treatment of exocrine pancreatic insufficiency, such as in patients with pancreatitis, cystic fibrosis, pancreatectomy, postoperative gastrointestinal surgery such as Bilroth I or II or bile duct obstructions of a neoplastic nature. Its dose must be adjusted depending on the severity of the disease, the control of the steatorrhea it produces and the maintenance of a satisfactory nutritional status, points out the Aemps, which adds that its consumption may cause cases of hypersensitivity to these exogenous proteins.
Furthermore, in high doses in patients with cystic fibrosis it has been associated with the appearance of intestinal and colonic strictures, and with colitis. Its use is linked to adverse reactions of a digestive nature , intestinal obstruction, dermatological, allergic and metabolic, but pancreatin can also cause irritation of the perioral skin and oral mucosa if it is retained in the mouth.
Therefore, "considering the aforementioned risks, as well as the fact that the aforementioned product (manufactured by the American company Now Foods) has not been subject to evaluation and authorization prior to marketing by the Aemps", it has been decided to withdraw the product market.