Second-Generation Antihistamines
Objective: To demonstrate that the safety profiles of second-generation antihistamines (SGAs) meet the criteria set by the Food and Drug Administration (FDA) for switching these products to over-the-counter (OTC) status.
Data Sources: Medline search of articles published from 1970 through 2000.
Summary:Most patients with allergic rhinitis treat their symptoms with first-generation antihistamines (FGAs), which are available over-the-counter (OTC). Yet FGAs are generally considered less safe than the newer drugs. FGAs cause central nervous system (CNS) adverse effects and may increase users' risk for work-related injuries and motor vehicle accidents and, in children, for learning impairment. SGAs cause fewer CNS effects, do not appear to affect learning in children, and do not have significant drug interactions. Several other countries have made SGAs available OTC. Blue Cross of California petitioned FDA in July 1998 to make this class of drugs available OTC in the United States. This petition will finally be heard in May 2001. The 1951 Durham_Humphrey amendment to the original Federal Food, Drug and Cosmetic Act of 1938 requires that "a drug be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance." If judged according to this and other criteria promulgated by FDA, SGAs should be strongly considered for being switched to OTC status.
Conclusion: The safety and efficacy of SGAs have been adequately established. Consumers should have the option of self-treating mild allergic rhinitis symptoms with these products.
Several actions taken by the Food and Drug Administration (FDA) over the past year indicate a heightened interest on the part of the agency in switching prescription drugs to over-the-counter (OTC) status. In late June 2000 FDA held hearings during which health care providers, pharmaceutical industry representatives, consumers, and advocacy groups voiced their opinions on what prescription products or product classes should or should not be switched to OTC status. The agency's role in the switch process was also explored during the hearing.
Subsequently, in July 2000 and October 2000, FDA reviewed petitions to switch two HMG-CoA reductase inhibitors, lovastatin (Mevacor -- Merck) and pravastatin (Pravachol -- Bristol-Myers Squibb), and the proton pump inhibitor omeprazole (Prilosec -- AstraZeneca) to OTC status. The Nonprescription Drug, Endocrine Advisory Committee and the Metabolic Drug, and the Gastrointestinal Drug Advisory Committee voted against recommending the switch of the products primarily because of concerns regarding labeling comprehension. These products can still be switched in the future if more information is provided to FDA. In July 1998 Blue Cross of California petitioned FDA to allow OTC sales of second-generation antihistamines (SGAs), including loratadine (Claritin_Schering), fexofenadine (Allegra_Aventis), and cetirizine (Zyrtec_Pfizer). The petitioners argued that the largest discrepancy in safety among all of the therapeutic drug classes available is that between the first-generation antihistamines (FGAs) and SGAs. On May 11, 2001, the Pulmonary-Allergy Drugs Advisory Committee will consider this petition.
The switch process has been brought into the public's awareness through the popular media. A series of articles published in USA Today in April 2000 outlined growing concern by society regarding the safety of FGAs in comparison with SGAs. As noted in these articles, the superior safety profile of SGAs has led other countries (Australia, Austria, Canada, Germany, the Netherlands, New Zealand, Sweden, Switzerland, and the United Kingdom) to make this class of drugs available OTC.
Are SGAs truly safer than the currently available OTC FGA products? This commentary summarizes the issues related to the OTC switch process, reviews the rationale for making SGAs available OTC, and demonstrates that, according to the criteria set by FDA, SGAs should be switched to OTC status.
Objective: To demonstrate that the safety profiles of second-generation antihistamines (SGAs) meet the criteria set by the Food and Drug Administration (FDA) for switching these products to over-the-counter (OTC) status.
Data Sources: Medline search of articles published from 1970 through 2000.
Summary:Most patients with allergic rhinitis treat their symptoms with first-generation antihistamines (FGAs), which are available over-the-counter (OTC). Yet FGAs are generally considered less safe than the newer drugs. FGAs cause central nervous system (CNS) adverse effects and may increase users' risk for work-related injuries and motor vehicle accidents and, in children, for learning impairment. SGAs cause fewer CNS effects, do not appear to affect learning in children, and do not have significant drug interactions. Several other countries have made SGAs available OTC. Blue Cross of California petitioned FDA in July 1998 to make this class of drugs available OTC in the United States. This petition will finally be heard in May 2001. The 1951 Durham_Humphrey amendment to the original Federal Food, Drug and Cosmetic Act of 1938 requires that "a drug be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance." If judged according to this and other criteria promulgated by FDA, SGAs should be strongly considered for being switched to OTC status.
Conclusion: The safety and efficacy of SGAs have been adequately established. Consumers should have the option of self-treating mild allergic rhinitis symptoms with these products.
Several actions taken by the Food and Drug Administration (FDA) over the past year indicate a heightened interest on the part of the agency in switching prescription drugs to over-the-counter (OTC) status. In late June 2000 FDA held hearings during which health care providers, pharmaceutical industry representatives, consumers, and advocacy groups voiced their opinions on what prescription products or product classes should or should not be switched to OTC status. The agency's role in the switch process was also explored during the hearing.
Subsequently, in July 2000 and October 2000, FDA reviewed petitions to switch two HMG-CoA reductase inhibitors, lovastatin (Mevacor -- Merck) and pravastatin (Pravachol -- Bristol-Myers Squibb), and the proton pump inhibitor omeprazole (Prilosec -- AstraZeneca) to OTC status. The Nonprescription Drug, Endocrine Advisory Committee and the Metabolic Drug, and the Gastrointestinal Drug Advisory Committee voted against recommending the switch of the products primarily because of concerns regarding labeling comprehension. These products can still be switched in the future if more information is provided to FDA. In July 1998 Blue Cross of California petitioned FDA to allow OTC sales of second-generation antihistamines (SGAs), including loratadine (Claritin_Schering), fexofenadine (Allegra_Aventis), and cetirizine (Zyrtec_Pfizer). The petitioners argued that the largest discrepancy in safety among all of the therapeutic drug classes available is that between the first-generation antihistamines (FGAs) and SGAs. On May 11, 2001, the Pulmonary-Allergy Drugs Advisory Committee will consider this petition.
The switch process has been brought into the public's awareness through the popular media. A series of articles published in USA Today in April 2000 outlined growing concern by society regarding the safety of FGAs in comparison with SGAs. As noted in these articles, the superior safety profile of SGAs has led other countries (Australia, Austria, Canada, Germany, the Netherlands, New Zealand, Sweden, Switzerland, and the United Kingdom) to make this class of drugs available OTC.
Are SGAs truly safer than the currently available OTC FGA products? This commentary summarizes the issues related to the OTC switch process, reviews the rationale for making SGAs available OTC, and demonstrates that, according to the criteria set by FDA, SGAs should be switched to OTC status.
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