Should the FDA to remove weight-loss drugs like Alli from the market?

When you take a weight loss drug that contains orlistat, about a quarter of the fat you consume passes through the body undigested and is excreted. Drugs that contain orlistat have been associated with severe liver injury, kidney stones and pancreatitis. Two weight-loss drugs that contain orlistat are Alli (generic) and its prescription form Xenical. Alli is available over-the-counter. Recently Glaxo decided to get rid of Alli according to a report in the Wall Street Journal: Glaxo to Shed Its OTC Diet Drug, Alli

Dorry Samuels of Public Citizen reports that Public Citizen petitioned the Food & Drug Administration (FDA) on April 14, 2011 to remove two weight-loss drugs containing orlistat from the market because they can cause severe injury to the liver, pancreas and kidneys. Alli has 60 mg of orlistat per pill and Xenical contains 120 mg per pill. The weight-loss benefits are marginal and the risks are high.

In April 2006 Public Citizen petitioned the FDA to remove Xenical because it caused pre-cancerous lesions in the colon. The FDA refused to remove the drug. Many cancers including pancreatic cancer are thought to be associated with inflammatory processes such as painful pancreatitis which may be a precursor to pancreatic cancer, a major killer and basically untreatable. The liver, kidneys, pancreas and colon do not need any more abuse than they already get. Alli and Xenical appear to trigger the destructive processes when a meal contains high fat content in the range of 15 grams or more. The first signs are upset stomach, loose stool and other digestive upsets.

According to Public Citizen the FDA Medwatch reported 47 cases of pancreatitis (39 were hospitalized and 1 died) and 73 cases of kidney stones (23 were hospitalized). Public Citizen reports that 3 people taking orlistat developed acute kidney failure because calcium salt crystals formed throughout the kidneys. Although use of the drugs is declining, there were still 110,000 prescriptions of Xenical in 2009. The percentages and trends are of little importance to someone who takes the drugs and develops a serious health problem.

How do you feel about the FDA allowing a drug with this history to get on the market in the first place and then stay on the market with the known consequences? It seems shocking to me.

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