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This article was originally published in The Tan Sheet

Executive Summary

OTC ANTITUSSIVE, BRONCHODILATOR MAO INHIBITOR INTERACTION WARNINGS are mandated by FDA in two separate final rules published in the Oct. 20 Federal Register. One final rule amends the final monograph for OTC antitussives by adding a statement warning that antitussives containing dextromethorphan or dextromethorphan hydrobromide should not used by individuals taking a prescription monoamine oxidase (MAO) inhibitor agent without first consulting a health professional. The second notice revises the final monograph for OTC bronchodilators to include an identical MAO inhibitor warning in order to make it consistent with the antitussive drug interaction precaution. FDA said it intends, in a future Federal Register notice, "to include the same drug interaction precautions in the final rule for OTC nasal decongestant drug products." The statements will apply to "oral nasal decongestants containing sympathomimetic amine drugs." The MAO inhibitor statements for antitussives and bronchodilators must be implemented by Oct. 20, 1994. For OTC antitussives, FDA specified two separate MAO inhibitor interaction precautions: one for general antitussives containing dextromethorphan and dextromethorphan hydrobromide; and one for dextromethorphan-containing antitussives intended for use by children. The general warning reads: "Drug interaction precaution: Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for two weeks after stopping the MAOI drug. If you are uncertain whether your drug prescription drug contains an MAOI, consult a health professional before taking this product." The warning for antitussives intended for children is essentially the same as the general warning, but specifies that consumers should not "give this product to a child who is taking" a prescription MAOI. FDA proposed to amend the antitussives monograph to include an MAO inhibitor interaction warning in a June 1992 notice of proposed rulemaking. That proposal also applied to general antitussives and antitussives intended for children, but did not include a warning against potential interaction with MAO B drugs such as selegiline and, therefore, did not caution consumers not to take dextromethorphan if they are taking drugs for Parkinson's disease. FDA called for comments on whether MAO B drugs should be included in the warning in a separate August 1992 notice. Despite assertions that there are few adverse reaction reports for the Parkinson's drug selegiline, FDA said that it "does not find the lack of adverse reaction reports for selegiline to be reassuring" because it is a "recently approved new drug with limited marketing experience." Therefore, FDA said, until more information is available on selegiline-dextromethorphan interactions, "the potential for interaction should be assumed." FDA clarified that "Parkinson's disease is not being included in the precaution statement on dextromethorphan-containing products labeled only for children under 12 years of age because it is not relevant to a pediatric population." In response to comments that the MAO inhibitor warning should be shortened, FDA maintained that "the serious nature of the adverse reactions requires that people taking MAOI drugs be given as much information as possible, so that they can make the correct decisions about the use of the OTC drug product." To be fully informative, FDA continued, the statement should include "both the technical and abbreviated terms for monoamine oxidase inhibitor (MAOI), should include likely medical uses for the MAOI drugs, [and] should mention a two-week washout period" to help ensure that patients will not discontinue use of the MAO inhibitor in order to use the OTC drug. Responding specifically to a suggestion that FDA should remove the statement that consumers should consult with a health professional if they are unsure whether their Rx drug contains an MAO inhibitor, the agency insisted that "it is important to tell consumers that if there is any uncertainty or doubt about using the OTC drug product, a health professional should be consulted." FDA concluded that "label space should [not] limit essential safety information. There are means available to extend label space, such as carton flaps or package inserts." For OTC bronchodilators containing sympathomimetic amine drugs, the drug interaction precaution statement is identical to the warning for OTC antitussives. However, unlike for antitussives, a specific warning for children is not included. As with antitussives, FDA proposed an MAO inhibitor interaction statement in a June 1992 notice of proposed rulemaking, and subsequently received similar comments on shortening the warning statement or deleting certain components. FDA rejected these suggestions for the same reasons cited in the proposal for antitussives.

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