Diarrhea: Sweeping Changes in the OTC Market
Diarrhea is one of the more dangerous problems for which patients seek self-care advice from the pharmacist. This is because of the potentially devastating effects of dehydration coupled with severe fluid and electrolyte loss. The FDA has published several recent documents on antidiarrheals and oral rehydration solutions.
When the FDA OTC Review began, a panel was assigned to review antidiarrheal products. In its 1975 report, the panel found only two ingredients to be safe and effective. Opiates were recommended for treatment for people as young as age 6, and polycarbophil was found safe for those 2 years and older. The panel found that Kaolin/pectin, a widely used combination product, lacked evidence of safety and/or efficacy.
In 1986, the FDA issued a proposed rule based on the panel report that had appeared 11 years earlier. The proposed rule found that opiates lacked sufficient evidence of safety and efficacy. They disappeared from the market soon thereafter. The report affirmed the safety of polycarbophil (and the newly submitted calcium polycarbophil) but recommended a label warning against their use in children younger than 3 years. The report also included the newly submitted ingredient attapulgite, proposed as safe and effective in those older than 3 years. The report designated bismuth subsalicylate as Category III.
In the late 1980s, the FDA approved an NDA for loperamide (Imodium A-D), with FDA-approved labeling for treatment of diarrhea in those as young as 6 years.
Diarrhea is one of the more dangerous problems for which patients seek self-care advice from the pharmacist. This is because of the potentially devastating effects of dehydration coupled with severe fluid and electrolyte loss. The FDA has published several recent documents on antidiarrheals and oral rehydration solutions.
When the FDA OTC Review began, a panel was assigned to review antidiarrheal products. In its 1975 report, the panel found only two ingredients to be safe and effective. Opiates were recommended for treatment for people as young as age 6, and polycarbophil was found safe for those 2 years and older. The panel found that Kaolin/pectin, a widely used combination product, lacked evidence of safety and/or efficacy.
In 1986, the FDA issued a proposed rule based on the panel report that had appeared 11 years earlier. The proposed rule found that opiates lacked sufficient evidence of safety and efficacy. They disappeared from the market soon thereafter. The report affirmed the safety of polycarbophil (and the newly submitted calcium polycarbophil) but recommended a label warning against their use in children younger than 3 years. The report also included the newly submitted ingredient attapulgite, proposed as safe and effective in those older than 3 years. The report designated bismuth subsalicylate as Category III.
In the late 1980s, the FDA approved an NDA for loperamide (Imodium A-D), with FDA-approved labeling for treatment of diarrhea in those as young as 6 years.