Nov 20, 2024
OTC Monograph Category Classification: Poison Treatment Drug Products for OTC Human Use.
OTC Monograph Reference Number and Announcement: M023
As part of the 2023 Annual Forecast for Planned Monograph activities, FDA has identified its plans to address the GRASE status of OTC ipecac labeled for poison treatment. Ipecac is one of two Category I active ingredients for poison treatment (activated charcoal).
In the emergency treatment of poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical since rapid treatment may be the difference between life and death. The reclassification of this drug product to prescription sale limits its availability in emergencies. On the other hand, it is the consensus of informed medical opinion that ipecac syrup should be used only under medical supervision. In view of these facts, the question of whether ipecac syrup labeled as an emergency treatment for use in poisonings should be available OTC has been controversial. Several professional organizations do not support the current OTC status. These societies and experts suggest that there are several factors that merit a reevaluation of the current OTC status of ipecac syrup including insufficient evidence of the benefits of therapy and decreased use of gastric emptying for treatment of poisonings. This is coupled to a possibility of mortality and morbidity from adverse events, and abuse and misuse reports associated with the availability of ipecac syrup.
In 1997 (Krenzelok et al., 1997) and 2013 (Hojer et al., 2013) position statements from the American Academy of Clinical Toxicology recommended against the use of syrup of ipecac for poisoning treatment. The European Association of Poison Centers and Clinical Toxicologists (EAPCCT) and the American Academy of Pediatrics (AAP) no longer recommend ipecac for routine use.
This proposed Administrative Order is targeted to products containing ipecac and labeled for poison treatment. The active ingredient of the product is powdered ipecac. It is marketed as ipecac syrup, USP in the quantity of 1 fluid ounce (30 milliliters) only.
March 21, 1975 (40 FR 12902) Establishment of Monographs for OTC Laxative, Antidiarrheal, Emetic and Antiemetic Products (Panel Report or ANPR).
September 5, 1978 (43 FR 39544) Tentative Final Order (TFM) for Emetic Drug Products for Over-the-Counter Human Use
March 21, 1980 (45 FR 18398) Acceptance of Data and Information into the Administrative Record
January 5, 1982 (47 FR 444) Establishment of a Monograph for OTC Human Use for the Treatment of Acute Toxic Ingestion.
January 15, 1985 (50 FR 2244) Poison Treatment Drug Products for Over-the-Counter Human Use: Tentative Final Monograph (TFM)
June 12, 2003 NDAC Meeting on the Regulatory Status of Ipecac
October 14, 2022 FDA published the Deemed Final Monograph Titled Poison Treatment Drug Products for OTC Human Use (M012).
Due to reports of morbidity and mortality from inappropriate use and declining use for gastric emptying, CHPA is unclear on whether ipecac will remain on the market as an OTC drug product. FDA will not provide additional information on why this ingredient was added to the FDA OTC annual forecast.