The Food and Drug Administration has only approved one over-the-counter drug. But now a consumer advocacy group is asking the FDA to ban the sale of the drug Alli and its more potent prescription counterpart Xenical. The group has cited numerous reports of medical problems from people who are using the drugs, and believes that the pharmaceuticals are dangerous.
But the manufacturer of the drug, GlaxoSmithKline, has asserted in the past that Alli has undergone more safety studies than any other weight loss medicine and that its safety has been “established through 100 clinical studies,” according to CBS News. The advocacy group however points to dozens of cases of acute pancreatitis and kidney stones reported by those using the medications.
The advocacy group, Public Citizen, reportedly reviewed the FDA’s adverse reporting database. The adverse reporting database allows the FDA to track the safety of drugs, post approval. Based on information and trends that appear in this database, the FDA may choose to conduct additional safety examinations of drugs that had been previously approved. In instances where serious medical outcomes and risks are identified the FDA can take regulatory actions such as enhancing labeling requirements or even pulling the drug off the market.
However, just because there have been adverse health effects reported while a person has been taking a drug, there is no certainty that a reported adverse event was caused by the pharmaceutical product. When there are very large numbers of people are using a drug or medical device there is some likelihood that at least a few of the people who are using them will have some adverse health event, whether or not it is related.
While the reports may not always show causation, this is an important early warning system for identifying when there maybe wide-spread risk from a drug.
Source: CBS News “Are FDA-approved diet drugs dangerous?” April, 15, 2011