Risks Associated with use of Ipecac Syrp as OTC Poison Treatment

OTC Monograph Category Classification: Poison Treatment Drug Products for OTC Human Use. 

OTC Monograph Reference Number and Announcement: M023

Background

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.

 OTC Active Ingredients Impacted

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.

Related Prior Regulations, Safety Communications, and other Supporting Documents

• There are no safety communications from FDA on this topic.
• Risks Associated with Use of Ipecac Syrup as OTC Poison Treatment was listed in both the 2022 Annual Forecast and the 2023 Annual Forecast. No data has been requested.

Regulatory Background and History

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

• In this notice, FDA reopened the administrative record for OTC laxative, antidiarrheal, emetic, and anti-emetic drug products.

January 5, 1982 (47 FR 444) Establishment of a Monograph for OTC Human Use for the Treatment of Acute Toxic Ingestion.

• This rulemaking contains the recommendations of the Advisory Review Panel on OTC Miscellaneous Internal Drug Products (MI Panel). The MI Panel classified ipecac syrup and activated charcoal as safe and effective to treat acute toxic ingestion.

January 15, 1985 (50 FR 2244) Poison Treatment Drug Products for Over-the-Counter Human Use: Tentative Final Monograph (TFM)

• This rulemaking contains FDA's tentative conclusions and proposed labeling on OTC poison treatment drug products. Because of overlap between the Emetic TFM and the Acute Toxic Ingestion ANPR, the agency decided to combine both rulemakings and publish a single TFM for Poison Treatment Drug Products

June 12, 2003 NDAC Meeting on the Regulatory Status of Ipecac

• A NDAC meeting was held on June 12, 2003, and the focus of the meeting was to discuss the regulatory status of ipecac syrup and whether the ingredient should remain OTC or be reconsidered as a Rx product. The transcript of this meeting of this meeting is available here. Note that a FDA ODS safety review was provided to the committee. The committee voted 10 "Yes” and 0 “No” on whether there is a safety concern with the OTC availability of this product.

October 14, 2022 FDA published the Deemed Final Monograph Titled Poison Treatment Drug Products for OTC Human Use (M012).

Expected Outcome

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.