The Long Battle to Discredit a Decongestant in Cold Medicines
Dr. Leslie Hendeles, with his iconic mop of curly red hair, first began challenging the Food and Drug Administration (FDA) to reject a decongestant in cold medicines back when Bill Clinton had just become president. Now, at the age of 80 and with hair turned white, Dr. Hendeles testified as an expert before the FDA’s advisers, providing a comprehensive overview of the ingredient’s history spanning 50 years. Finally, after years of advocacy, the advisory panel unanimously voted to declare the decongestant, phenylephrine, ineffective.
The news prompted consumers to inspect their medicine cabinets, discovering that phenylephrine was listed in over 250 of their favorite congestion remedies, such as DayQuil, Sudafed, Tylenol, and Theraflu. However, there is some confusion surrounding the decision—experts clarify that the ingredient still works in nasal sprays but not in pill or liquid form when taken orally.
While the drug is considered safe, experts recommend keeping the products that contain other effective ingredients and not throwing them away. The FDA will need to review the advisory panel’s decision, gather public comments, and likely provide drug manufacturers with time to adjust or replace the ingredients before making a final decision. Potential delays may arise if the companies contest the decision in court. Furthermore, some experts, like former FDA commissioner Dr. Scott Gottlieb, argue that phenylephrine does work to some extent, and defenders of the drug may resist a complete ban.
The story of how phenylephrine remained on the market despite years of studies and questioning is complicated, involving outdated drug standards, the rise of meth labs in the 1990s using cold remedies, and even the COVID-19 pandemic. Like many federal agencies, the FDA can be slow to act due to archaic rules and regulatory procedures.
The process of challenging phenylephrine’s effectiveness spanned around six decades. In the Kennedy era, a new law required the FDA to evaluate a drug’s effectiveness in addition to safety standards. However, it wasn’t until 1976 that the FDA started reviewing over-the-counter cold medicines like phenylephrine as a drug class.
By the early 1990s, phenylephrine still didn’t receive full approval, catching the attention of Dr. Hendeles and a group of pharmacy professors from the University of Florida. They became tireless advocates, pressuring the FDA to take action. Dr. Hendeles published his first critique of the drug in 1993, arguing that phenylephrine was destroyed in the stomach, rendering it ineffective.
In the 2000s, illegal methamphetamine labs, particularly in rural areas of the West Coast, started using pseudoephedrine, a common decongestant, as their ingredient of choice. This led to the passage of laws restricting pseudoephedrine sales, and pharmaceutical companies turned to phenylephrine as an alternative. However, patients complained that phenylephrine did not provide relief, prompting Dr. Hendeles and Dr. Randall Hatton to dig deeper and reevaluate the drug’s initial approval data. They discovered memos from the 1960s and 1970s that had not undergone peer review, and after running the data through modern analysis software, they concluded that phenylephrine was no more effective than a placebo.
Efforts to ban phenylephrine faced challenges due to a beleaguered FDA over-the-counter division and the involvement of former FDA commissioner Dr. Scott Gottlieb, who believed more studies were needed before concluding that the drug was ineffective. The COVID-19 pandemic led to adjustments in staffing and procedures at the FDA, which eventually prompted a thorough review of phenylephrine’s efficacy by the agency.
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