The drug Lotronex (alosetron hydrochloride) should be pulled from the U.S. market because of its risk of serious side effects, the consumer group Public Citizen has said in a petition to the Food and Drug Administration (FDA). The group, founded by current Green Party Presidential candidate Ralph Nader, is asking the FDA to immediately withdraw Lotronex, a prescription drug approved last February for treating women with one type of irritable bowel syndrome (IBS).
Last week, the FDA strengthened warnings about Lotronex in response to 19 so far linking the drug to serious side effects. This makes it the be the first drug required to carry a consumer-friendly guide with every bottle to explain possible risks. The agency also toughened the cautions written for doctors.
Public Citizen disagreed with the FDA's new warning labels, saying in its petition that Lotronex offered only "limited" relief while exposing patients to possibly life-threatening adverse effects.
The group said its review of FDA documents showed that up to that point Lotronex had been associated with at least 26 cases of ischemic colitis, a serious condition that restricts blood flow to the colon.
The FDA has also linked Lotronex to rare cases of severe constipation.
Public Citizen said it did not think those measures were enough to prevent further harm, or even death, from Lotronex. "You will have best protected patients when you assure that this drug is banned," the group said to the FDA.
Irritable bowel syndrome afflicts an estimated 25 million Americans, most of them women, with frequent diarrhoea, constipation or both.
An FDA official said the agency will review Public Citizen's comments. "We will carefully consider the petition," the official said.
Public Citizen's Health Research Group
If the diet fails to improve the problem, there is almost always an underlying emotional issue. Typically this is related to an ongoing stress in one's life, but it can be due to previous emotional wounding that was thought to be resolved.
Congratulations to Public Citizen for doing the valuable press release and lobbying work to help guard us against the drug companies.
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