One of the most used in OTC medications for constipation have not been approved for use by children. However, doctors often suggest and parents often given to children with constipation, sometimes for years.
Researchers now the FDA has requested in Philadelphia to give polyethylene glycol 3350 (also known as MiraLAX) a second look.
doctors have assumed that PEG 3350 is not absorbed into the body, but no one has reviewed to ensure that young children are handled in the same way as adults. The FDA recently revealed that several batches of drug tested in 2008 contained small amounts of ethylene glycol and diethylene glycol, toxic compounds found in antifreeze.
An advocacy group Health, Consumer Project Empire State asked the agency in 2012, to study the safety of this laxative. The new research will investigate whether the compound has psychiatric side or behavior such as tics or obsessive-compulsive disorder, a possibility that is of grave concern to parents effects.
Catherine Saint Louis, the New York Times has been reporting for years about MiraLAX concerns. In 2012 she wrote .
“Despite the popularity of the drug, which has never been approved by the FDA for pediatric use in 1999, when the FDA approved first Miralax, the patient material included the warning: “. Miralax should not be used by children” in 2009, an FDA oversight board drug safety raised a number of concerns about the use of PEG in children, including uncertainty of the long-term effects of large doses, but concluded that current evidence does not suggest that PEG causes severe side effects.
“still, some doctors said they are concerned about the lack of information about their long-term effects. “We do not know 30 years from now what will happen,” said Dr. Carlo Di Lorenzo, the head of the department of gastroenterology at the National Children’s Hospital in Columbus, Ohio. “
January 5 2015 its headline read “. Scrutiny of laxatives as a cure childhood “ she went on to write
“doctors have always recommended these laxatives for your convenience and on the basis of very little PEG 3350 is absorbed in the intestine. But the F.D.A. He says there is little data on absorption in children, especially younger ones and chronic constipation. The agency has never approved the daily long-term use of laxatives, even in adults.
“Moreover, for years the F.D.A. has received occasional reports of tremors, tics and obsessive compulsive behavior in children given laxatives containing PEG 3350. It is not known if laxatives are the cause.”
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