Expert Opinions

Anthony S. Manoguerra, Pharm.D., DABAT, FAACT


November 16, 2005


To: Pre-IND Committee for Activated Charcoal Cookie

I am writing this letter to support the concept of an easily administered, palatable and effective dosage form for administration of activated charcoal to children in the home or pre-hospital environment. I understand that preliminary work on the activated charcoal cookie shows promising results and I would support continued activity on this product.

I was invited to testify in 2003 before an FDA advisory committee exploring the status of ipecac syrup. The general consensus lirom that meeting, as well as subsequent discussions of the topic among toxicology and pediatric organizations, is that ipecac syrup use should be abandoned as it has not been shown to positively affect the outcome of poisoned patients. I was also the primary author on the Guideline on the Use of Ipecac Syrup in the Out-of-hospital Management of Ingested Poisons produced by the Guidelines for the Management of Poisonings National Consensus Panel (Clinical T oxicology, l:l-l0, 2005). Ipecac had been used for many years in the hope that use of this product in patients who had ingested potentially toxic but not life threatening amounts of toxic materials could be managed at home thus avoiding a hospital visit and the resulting emotional and financial cost. Unfortunately, ipecac proved not to be as effective as had been hoped. Since then, many toxicologists have advocated activated charcoal administration in the home as an alternative to ipecac. Numerous in-vitro and in-vivo studies have demonstrated the effectiveness of activated charcoal in reducing the absorption of toxins from the gastrointestinal tract. However, the problems that have confronted the pre-hospital use are the lack of palatability and the messiness of use that keeps caretakers Hom administering effective amounts to children. I believe that a dosage form that allows a caretaker, under the direction of a poison control center or other health care provider, to administer an effective dose of activated charcoal to a child, in the home, in a short time frame would be embraced by the poison center and toxicology communities. In addition, in the emergency department, administration of activated charcoal to children is often a difficult and trying procedure. Children typically refuse the aqueous product and physicians often must resort to the placement of a nasogastric tube to facilitate administration. This is very traumatic to the child and has, in the past, resulted in aspiration of charcoal into the lungs. A product that could avoid these problems would be very useful. I have seen the proposed activated charcoal cookie and it appears to be a dosage form that would be familiar to children because of the cookie construction and chocolate flavor. It should have a greater likelihood of being taken by a child than existing liquid dosage forms.

Should the committee require any additional comment from me, please do not hesitate to contact me.


Anthony S. Manoguerra, Pharm.D., DABAT, FAACT

Associate Dean for Student Affairs and Professor of Clinical Pharmacy Skaggs School of Pharmacy and Pharmaceutical, Sciences Clinical Professor of Pharmacology School of Medicine and Former Director, San Diego Division California Poison Control System


Anthony Manoguerra, Pharm.D., DABAT, FAACT, now retired, is the former Associate Dean for Student Affairs and Professor of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences. He was also clinical Professor of Pharmacology, School of Medicine and Former Director, San Diego Division of the California Poison Control System.

Dr. Manoguerrra has served as reviewer and as a member of the editorial board of many publications including AMA Drug Evaluations, Drug Safety, JAMA, Journal of Toxicology, Journal of Toxicology, Drug Investigation and Annals of Emergency Medicine. He is author/co-author of over sixty journal articles, over twenty-five book chapters and over fifty scientific papers.