Drugs

FDA Denies PEG 3350 Selenium Petition

FDA has denied a 2/26/16 Empire State Consumer Project (ESCP) petition asking that it test all brands of OTC and prescription drug products containing polyethylene glycol 3350 (PEG 3350) for the presence of selenium, determine the source of any selenium found in the tested products, and issue a recall of any PEG 3350 products found to contain selenium. The petition also asked FDA to establish a safe selenium limit on drugs prescribed to children for long-term use.

The denial letter describes PEG 3350 as an osmotic agent that retains water within the stool and, at large doses, produces an osmotic diarrhea. It is an active ingredient in a number of prescription and OTC products including CoLyte, Moviprep, GoLytely, and MiraLAX.

According to the petition, ESCP tested three OTC PEG 3350 products for the presence of selenium in 2/2016 and detected measurable quantities of selenium in every sample tested. ESCP said the test results raise a potentially significant pediatric safety issue because the products are routinely prescribed to treat constipation in children and infants.

FDA says it reviewed the levels of selenium in approved PEG 3350 drug products and the potential sources of selenium in such products. It says it tested five OTC products and did not detect any selenium. It says it could not determine the root causes of the disparity between the agency test results and those obtained by ESCP because the petition did not include any information about ESCP’s analytical method.

A review of adverse events reports found insufficient evidence of a link between PEG 3350 products and chronic selenium toxicity, the letter says. Finally, it says, the agency found no evidence that selenium is likely to be introduced into PEG 3350 products during the manufacturing process.

“Based on the available information, FDA has determined that the amount of selenium in PEG 3350, if any, does not pose a safety risk,” the letter says. “PEG 3350 drug substance and drug product manufacturers are subject to Federal Food, Drug, and Cosmetic Act requirements prohibiting the introduction or delivery for introduction into interstate commerce of adulterated drugs, including drugs that do not satisfy the CGMP and USP monograph requirements…. At this time, we are not aware of any PEC 3350 drug substance or drug product manufacturers that are not in compliance with these requirements.”

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