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Phenylephrine is useless. How many more drugs like it are out there?

by Mark Mendoza

The Food and Drug Administration (FDA) recently declared phenylephrine, a common decongestant used in over-the-counter cough and cold medications, to be ineffective when taken orally. This unanimous decision by the FDA advisory panel means that popular name-brand medications like Sudafed PE and Dayquil, which contain phenylephrine, are not actually providing relief for runny noses as advertised.

The FDA’s opinion, however, does not include phenylephrine preparations administered through the nose, such as drops and sprays, as these are more likely to reduce congestion since they bypass metabolism by the body. It is expected that the FDA will soon ban phenylephrine from over-the-counter sales, leading to a significant change in the range of available medications. Pseudoephedrine, another decongestant that is more effective, but complicated to obtain due to its misuse in methamphetamine production, may become the primary alternative.

The recent revelation about phenylephrine’s ineffectiveness is not a new discovery. Scientists have been publishing studies suggesting its inefficacy since the 1970s. In 2007, researchers from the University of Florida raised concerns about the drug’s utility to the FDA, leading to a panel convening to address phenylephrine’s effectiveness. The panel urged further research, and phenylephrine remained on shelves. However, recent large clinical trials with stronger measures proved enough for the latest FDA panel to accept that the drug clearly does not work.

Phenylephrine is not the only drug with questionable efficacy on the market. Due to the FDA’s limited resources and a historical lack of efficacy standards, there are several older drugs still available without proof of their effectiveness. The FDA has been reviewing the efficacy of these older drugs for years, but progress has been slow. The removal of drugs that are safe but ineffective is a necessary cleanup process, even if it may confuse the general public.

Historically, the FDA focused primarily on drug safety, with efficacy requirements only enforced since the 1960s. The sulfanilamide tragedy in the 1930s, which led to the passage of the Food and Drug Act in 1938, marked the first time drugs had to be safe. Efficacy requirements were later implemented in the Kefauver-Harris Amendments in the 1960s. Efforts to review and remove drugs lacking efficacy started in the 1970s.

The science regarding phenylephrine’s effectiveness is problematic due to outdated studies conducted before the 1990s. The endpoints of these trials were inconsistent, ranging from nasal air resistance to self-reporting by patients. To assess a drug’s effectiveness, standardized measures should be used, such as validated patient-reported outcomes.

The delay in the FDA seriously considering removing phenylephrine from the over-the-counter market could be due to resource limitations and the agency’s primary focus on drug safety. However, under Scott Gottlieb’s leadership, the FDA approved numerous drugs based on preliminary data, leading to a wave of drugs now being reviewed for efficacy. The confirmatory trials for many of these drugs are not confirming their initial signs of effectiveness and safety.

Regarding the assertion that consumers will be burdened if phenylephrine is removed from store shelves, this claim is ludicrous. Removing a placebo drug that doesn’t provide relief does not strain consumers or diminish their options.

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