Colonoscopy preperation drug OsmoPrep faced an petition to remove it from the market. Natasha Leskovsek petitioned the FDA in September 2007 making two demands:
- withdraw FDA approval for oral sodium phosphate (OSP) products for bowel cleansing, including OsmoPrep; or
- add a black box warning to OSP products regarding the potential risks of renal failure caused by nephrocalcinosis and reclassify all OSP products for bowel cleansing as prescription only medicines.
Ms. Leskovsek partially got her way. The FDA responded with an 18 page statement stating “[a]fter a thorough review of the information submitted and currently available relevant scientific literature, we conclude that there is new safety information regarding acute phosphate nephropathy that supports granting some of your requests. Accordingly, we have notified the NDA holder for prescription OSP products of the requirement to add a boxed warning to the labeling of these products. We also plan to amend the TFM to remove the proposed professional labeling for OSP products. Therefore, OSP products indicated for bowel cleansing will be available only by prescription. However, your request to withdraw the marketing authorization of prescription OSP products for bowel cleansing is not supported by sufficient evidence. Therefore, your petition is granted in part and denied in part.”
OsmoPrep is a product used before a colonoscopy. It was licensed in 2006 by the US Food and Drug Administration. Basically the drug allows doctors to get a better view of the colon by inducing loose bowels. Two years after OsmoPrep was approved, the FDA publicly announced the addition of a black box warning of kidney damage to the labeling of these products.
Controversy surrounded OsmoPrep since its approval by the FDA. The problem with this drug is the main ingredient called Sodium Phosphate. Sodium Phosphate is linked to severe kidney damage. Although OsmoPrep contains approximately 20% less sodium phosphate than other laxatives it has caused serious kidney damage in some people.
In some cases kidney damage after OsmoPrep was permanent, eventually requiring dialysis (treatment to remove waste from the blood when the kidneys are not working well). Some people developed kidney damage within a few days after exposure to OsmoPrep and others developed kidney damage up to several months after their treatment.