In a recent development, it has been discovered that a commonly used ingredient in cold medicines, phenylephrine, is ineffective in treating congestion. Despite being FDA approved, phenylephrine has never been properly studied for its effectiveness until now. Last month, an FDA panel unanimously concluded that phenylephrine is "useless and no better than a placebo." This revelation raises questions about the FDA approval process and the efficacy of other FDA-approved remedies.
The FDA approval process has evolved over the years. Initially, when the FDA was established in 1938, its primary focus was on ensuring the safety of drugs. It wasn't until 1962 that Congress required the FDA to also demonstrate the effectiveness of drugs. Consequently, many drugs approved prior to 1962 were deemed safe but may not have been proven to effectively treat the intended disease. The FDA created a process to review these previously approved drugs, but limited resources and staffing have hindered thorough evaluations. As a result, phenylephrine slipped through the cracks until now.
The future of phenylephrine remains uncertain. The FDA may choose to ban it from the market, but this process will likely take time. Additionally, the FDA is not obligated to follow the advice of its panels, although it typically does. In the meantime, cold remedies containing phenylephrine are still available for purchase and continue to make claims about treating congestion.
This discovery also raises concerns about other ineffective treatments that are not subject to FDA review, such as homeopathic remedies. Zicam, a product that claims to "shorten colds," falls into this category. Homeopathic remedies are not required to provide medical evidence or undergo FDA evaluation. While these ineffective treatments persist in the market, it is important for consumers to exercise caution and scrutinize product claims.
Ultimately, there is no conclusive cure for the common cold. Despite the numerous claims made by various cold remedies, the best course of action remains drinking warm liquids, getting plenty of rest, and staying home. It is crucial for individuals to be aware of the limitations of available treatments and make informed decisions about their health.