FDA Says 'Key Element' in Cold, Cough Medicines Not Effective: What It Means

Phenylephrine is a popular ingredient found in most over-the-counter drugs such as Nyquil, Benadryl, and Sudafed.

Phenylephrine, a key element in cold and allergy medication, is ineffective in relieving nasal congestion, the United States Food and Drug Administration, said on Tuesday, 12 September. 

Phenylephrine – a popular ingredient found in most over-the-counter drugs such as Vicks Nyquil, Benadryl, and Sudafed – generated almost USD 1.8 billion in sales revenue in 2022, the FDA said.

What the advisory committee found: Up until now, it was thought that Phenylephrine helps in decongestion by reducing the swelling of the blood vessels.

But the advisory panel found that it is ineffective, because when it is consumed orally, the quantity that actually reaches your nose is minimal. 

The committee went through five different studies that had been conducted in the last 20 years and found that:

• Phenylephrine is not anymore effective than a placebo.

• Phenylephrine showed inconsistent results.

• The data about the ingredient was not totally reliable.

• It did not match modern standards.

But, phenylephrine also has side effects that the FDA has taken note of.

• Headaches

• Insomnia 

• Nervousness

• High blood pressure

Why it could lead to: The news of it being ineffective could “disrupt the market where consumers prefer pills over nasal sprays,” NBC News reported. 

This also means that the FDA now will have to decide whether the designation that phenylephrine had – generally recognised as safe and effective – will be revoked or not.

If the designation is actually revoked, all the drugs that have phenylephrine will have to be taken off shelves. 

However, there’s an alternative to phenylephrine available, called pseudoephedrine, which has many restrictions attached to it.

What experts have said: Susan Block, a member of the advisory committee that concluded this, told NBC News, “The evidence is pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion.”

“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant.”

Dr Peter Starke, an FDA official who was part of the team reviewing phenylephrine

The committee’s recommendation said that while taking an ineffective drug isn’t dangerous per se, it’s redundant, has side effects, and could delay treatment by other means.

“I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.”

Maria Coyle, panel’s chairwoman to New York Times