One of the most widely used over the counter medicines for constipation has never been approved for use by children. Nonetheless, doctors often suggest it and parents often administer it to constipated kids, sometimes for years.
Now the FDA has asked researchers in Philadelphia to give polyethylene glycol 3350 (aka MiraLAX) a second look.
Doctors have assumed that PEG 3350 is not absorbed into the body, but no one has checked to make sure that young children handle it in the same way as adults. The FDA revealed recently that several batches of the drug tested in 2008 contained small amounts of ethylene glycol and diethylene glycol, toxic compounds found in antifreeze.
A health advocacy group, the Empire State Consumer Project, petitioned the agency in 2012 to study the safety of this laxative. The new research will investigate whether the compound has psychiatric or behavioral side effects such as tics or obsessive compulsive disorder, a possibility that is of grave concern to parents.
Catherine Saint Louis of the New York Times has been reporting about MiraLAX concerns for years. In 2012 she wrote:
“Despite the drug’s popularity, it has never been approved by the F.D.A. for pediatric use. In 1999, when the F.D.A. first approved Miralax, the patient materials included the warning: “Miralax should not be used by children.” In 2009, an F.D.A. drug safety oversight board raised a number of concerns about PEG’s use in children, including the uncertainty of the long-term effects of large doses, but concluded that current evidence does not suggest that PEG causes severe side effects.
“Even so, some doctors said they are concerned about the lack of information about its long-term effects. ‘We don’t know 30 years from now what will happen,’ said, Dr. Carlo Di Lorenzo, the chief of the gastroenterology department at Nationwide Children’s Hospital in Columbus, Ohio.”
On January 5, 2015 her headline read: “Scrutiny for Laxatives as a Childhood Remedy.” She went on to write:
“Doctors have long recommended these laxatives for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines. But the F.D.A. says there is little data on its absorption in children, especially the very young and chronically constipated. The agency never approved long-term daily use of the 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 whether the laxatives are the cause.”
We know that many visitors to this website love MiraLAX. It works. But do take a minute or two to read the latest New York Times report. It poses some challenging questions. We also encourage you to share your experience below.
