FDA Panel Votes Unanimously to Declare Decongestant Ineffective in Cold Medicines

The FDA advisory panel has voted unanimously to declare the decongestant phenylephrine ineffective in cold and flu remedies, prompting consumers to reevaluate their medicine cabinets. Phenylephrine is listed in over 250 commonly used drugs for congestion relief, including popular brands like DayQuil, Sudafed, Tylenol, and Theraflu. However, experts clarify that the ingredient still works effectively in nasal sprays but not when taken orally in pill or liquid form.

While the FDA panel’s decision has caused some confusion among consumers, experts emphasize that there is no immediate need to throw away products containing phenylephrine. These drugs typically contain other active ingredients that are effective in relieving congestion. FDA officials will review the panel’s decision, solicit public comments, and likely give drugmakers some time to adjust or replace ingredients before making a final determination. It is also possible that companies may contest the decision in court, further delaying any potential action.

Notably, some experts, including former FDA commissioner Dr. Scott Gottlieb, have long maintained that phenylephrine does work to some extent. They argue against completely banning the decongestant and may oppose any action that removes it from the market altogether.

The story of how phenylephrine remained on the market for so long despite decades of studies and questions is a complex one. It involves outdated drug standards dating back to a law signed by President John F. Kennedy, the rise of meth labs using common cold remedies in the 1990s, and even the impact of the pandemic.

The FDA, like other federal agencies, has been criticized for its slow-moving processes and outdated regulations. However, recent developments indicate that the agency is making efforts to address these issues and improve its oversight of over-the-counter medications. Dr. Joshua Sharfstein, a former FDA official, believes that the agency is finally shedding its regulatory constraints.

The journey to scrutinize phenylephrine, a drug used for dilating eyes and calming hemorrhoids, has taken approximately six decades. In the 1970s, the FDA began reviewing over-the-counter cold medicines, including phenylephrine, to evaluate their effectiveness in addition to safety standards. However, by the early 1990s, phenylephrine had not received full approval, catching the attention of Dr. Leslie Hendeles and a group of pharmacy professors at the University of Florida.

Hendeles published his first critique of phenylephrine in 1993, highlighting that the drug was destroyed in the stomach and did not effectively reach the bloodstream or nasal passages. Meanwhile, the proliferation of illegal methamphetamine labs in the 2000s led to restrictions on the sale of products containing pseudoephedrine, another common decongestant. To maintain sales, companies turned to phenylephrine as an alternative.

Hendeles and his colleague, Dr. Randall Hatton, delved deeper into the data used for phenylephrine’s initial approval in the 1970s. They discovered previously unreviewed memos and ran the data through modern analysis software, concluding that the drug was no better than a placebo. Despite their efforts, the FDA initially responded by suggesting that consumers who did not find relief from phenylephrine could choose not to purchase it.

Hendeles persisted and petitioned the FDA for a dosing review and examination of the drug’s use in children. This led to a public FDA advisory hearing in 2007, where the Consumer Healthcare Products Association argued that phenylephrine was effective. However, the advisory committee voted 11-1 in favor of further research, indicating that evidence supporting phenylephrine’s effectiveness was insufficient.

Eight years later, a study funded by Merck, the company that had acquired Schering Plough, confirmed that phenylephrine did not relieve symptoms even at higher doses. The Florida pharmacists petitioned the FDA for a ban, but their efforts were hindered by a lack of resources and a cumbersome regulatory process within the agency.

Interest in phenylephrine was reignited after pandemic legislation expanded FDA staffing and streamlined procedures for over-the-counter drugs. The FDA team conducted a comprehensive review of phenylephrine, which served as the basis for the advisory panel’s unanimous decision. The agency’s report confirmed the findings of Hendeles and his colleagues and highlighted potential bias in the 1970s data that initially led to phenylephrine’s acceptance.

While the FDA panel’s decision is a significant milestone, it does not immediately remove products containing phenylephrine from store shelves. Consumers are advised to consult healthcare professionals and consider alternative options. Lawyers representing individuals who purchased cold and flu medicines containing phenylephrine have already announced lawsuits against drugmakers, alleging that the companies knew the decongestant was ineffective.

The fight to address the issue of phenylephrine’s efficacy is far from over. However, the FDA’s recent actions indicate a commitment to improving the regulation of over-the-counter medications and ensuring that consumers have access to effective treatments for their symptoms.