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Syrup of Ipecac Still Number One Choice
Syrup of Ipecac Still Number One Choice
Syrup of ipecac is still the most effective and dependable emetic for treating systemic poisoning.! Introduced into Europe from its native South America in the late 17th century, it was used as a secret remedy for dysentery until France's King Louis XIV bought the secret and made it public property. 2 Since then, ipecac has become the best known emetic for treating systemic poisoning, with 2 million dosage units sold in the United States in 1979, according to an industry estimate. While it is agreed that ipecac syrup (not the highly toxic ipecac extract) is the best emetic for poison management, opinions vary on exactly how the drug should be used. Since FDA's publication of a tentative final order for the labeling of OTC emetic drug products in 1978, the agency has received dozens of comments from poison management experts that are generally favorable to the proposed labeling but that reflect the diversity of opinion regarding the drug's use. The updating of ipecac syrup labeling, part of FDA's review of all OTC drug product labeling, is expected to be completed within a year and will take into consideration the comments received. One of the major points raised in the comments can be divided into what may be termed an "urban" view and a "rural" view of poison management, Michael Kennedy, a biologist in FDA's division of OTC drug evaluation, told American Pharmacy. The urban poison control experts are asking the FDA to put a minimum of information on the label, simply urging the patient to call a local poison control center. They claim that many of their patients would be confused by an involved
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set of instructions on the label. Poison control centers or knowledgable emergency room staffs are available in most cities and are a short distance from most patients. The alternative, rural view reflects the needs of a different population with less access to medical resources. It holds that patients in rural areas may not be able to contact a poison control center because they may have no telephone or they may be several hours from the nearest medical facility. These patients need all the information they can get to take care of a poisoning themselves.
Petroleum Distillates Another area of concern is FDA's proposed warning that syrup of ipecac not be given when petroleum distillates have been ingested. Several comments urge that use of syrup of ipecac be considered in these cases because although the danger of aspiration is real, lung damage can be medically treated more easily than CNS damage caused by absoption of the distillates. FDA also warns against administering the drug with carbonated beverages because this could cause distention of the stomach. But according to one comment, "there is no evidence in the professional literature that gaseous distention of the stomach, which can be relieved by
belching, is counterproductive to ipecac syrup-induced emesis." The safety of ipecac's use in children under one year of age was a point raised by several experts. The proposed label recommends use of syrup of ipecac in children under one year of age "as directed by a physician." Several comments called for the use of ipecac syrup only under "direct medical supervision" because of an increased risk of aspiration in children this age because they have no gag reflex. The FDA "disagrees with the contention that a physician must be present when ipecac syrup is administered to an infant under 1 year of age. The existence or nonexistence of a gag reflex in infants has not been positively established, but the issue is irrelevant because ipecac acts directlyon the vomiting reflex center in the brain to produce vomiting . .. the immediate availability of an emetic for use in poisoning (including in infants) is critical because rapid treatment may be the difference between life and death." A number of pharmacists and pharmacy organizations requested that the FDA include pharmacists in the list of those to be called in case of accidental poisoning (physician, poison control center, or emergency room). The FDA, however, declined to specifically name pharmacists on the label stating that the labeling for OTC drugs includes a warning to seek professional assistance in case of accidental overdose. "The pharmacist is one of the health professionals that a consumer might choose to consult," the agency says. 0
References 1. Federal Register, 43 , 39545 (September 5, 1978). 2. F.H . Garrison, " An Introduction to the History of Med· icine," W.B. Saunders Company, Philadelphia, 1929.
American Pharmacy Vol. NS21, No.2, February 1981 /10:
1
Syrup of ipecac is still the most effective and dependable emetic for treating systemic poisoning.! Introduced into Europe from its native South America in the late 17th century, it was used as a secret remedy for dysentery until France's King Louis XIV bought the secret and made it public property. 2 Since then, ipecac has become the best known emetic for treating systemic poisoning, with 2 million dosage units sold in the United States in 1979, according to an industry estimate. While it is agreed that ipecac syrup (not the highly toxic ipecac extract) is the best emetic for poison management, opinions vary on exactly how the drug should be used. Since FDA's publication of a tentative final order for the labeling of OTC emetic drug products in 1978, the agency has received dozens of comments from poison management experts that are generally favorable to the proposed labeling but that reflect the diversity of opinion regarding the drug's use. The updating of ipecac syrup labeling, part of FDA's review of all OTC drug product labeling, is expected to be completed within a year and will take into consideration the comments received. One of the major points raised in the comments can be divided into what may be termed an "urban" view and a "rural" view of poison management, Michael Kennedy, a biologist in FDA's division of OTC drug evaluation, told American Pharmacy. The urban poison control experts are asking the FDA to put a minimum of information on the label, simply urging the patient to call a local poison control center. They claim that many of their patients would be confused by an involved
46
set of instructions on the label. Poison control centers or knowledgable emergency room staffs are available in most cities and are a short distance from most patients. The alternative, rural view reflects the needs of a different population with less access to medical resources. It holds that patients in rural areas may not be able to contact a poison control center because they may have no telephone or they may be several hours from the nearest medical facility. These patients need all the information they can get to take care of a poisoning themselves.
Petroleum Distillates Another area of concern is FDA's proposed warning that syrup of ipecac not be given when petroleum distillates have been ingested. Several comments urge that use of syrup of ipecac be considered in these cases because although the danger of aspiration is real, lung damage can be medically treated more easily than CNS damage caused by absoption of the distillates. FDA also warns against administering the drug with carbonated beverages because this could cause distention of the stomach. But according to one comment, "there is no evidence in the professional literature that gaseous distention of the stomach, which can be relieved by
belching, is counterproductive to ipecac syrup-induced emesis." The safety of ipecac's use in children under one year of age was a point raised by several experts. The proposed label recommends use of syrup of ipecac in children under one year of age "as directed by a physician." Several comments called for the use of ipecac syrup only under "direct medical supervision" because of an increased risk of aspiration in children this age because they have no gag reflex. The FDA "disagrees with the contention that a physician must be present when ipecac syrup is administered to an infant under 1 year of age. The existence or nonexistence of a gag reflex in infants has not been positively established, but the issue is irrelevant because ipecac acts directlyon the vomiting reflex center in the brain to produce vomiting . .. the immediate availability of an emetic for use in poisoning (including in infants) is critical because rapid treatment may be the difference between life and death." A number of pharmacists and pharmacy organizations requested that the FDA include pharmacists in the list of those to be called in case of accidental poisoning (physician, poison control center, or emergency room). The FDA, however, declined to specifically name pharmacists on the label stating that the labeling for OTC drugs includes a warning to seek professional assistance in case of accidental overdose. "The pharmacist is one of the health professionals that a consumer might choose to consult," the agency says. 0
References 1. Federal Register, 43 , 39545 (September 5, 1978). 2. F.H . Garrison, " An Introduction to the History of Med· icine," W.B. Saunders Company, Philadelphia, 1929.
American Pharmacy Vol. NS21, No.2, February 1981 /10:
1