The Food and Drug Administration (FDA) – the top US drug regulator – has proposed removing oral phenylephrine, a common ingredient in many over-the-counter (OTC) cold and cough medications, saying it may cause nasal congestion. Not effective in relieving congestion.

The proposal, announced last month, came after an expert panel voted unanimously last year that oral phenylephrine does not work as intended and that no further trials are needed to confirm it.

Phenylephrine is widely found in popular cold medications, including Benadryl, Advil, and Tylenol. It is also used in nasal sprays, but the FDA clarified that its proposal only targets the oral form, not the nasal spray version.

It comes as companies such as Procter & Gamble and UK pharmaceutical giant GSK were among a number of defendants accused in lawsuits over misleading consumers about cold medicines.

The FDA is now seeking public feedback on this proposal. Until a final decision is made, manufacturers may continue to sell oral phenylephrine-containing products.

However, the agency assured that if the proposal is finalized, drug manufacturers will be given sufficient time to either reformulate their products or remove them from the market.

Health Concerns About Oral Phenylephrine

There are several health concerns associated with oral phenylephrine, which is the reason behind the FDA’s proposal to ban this ingredient in various common cold formulations.

Dr. Vikas Mittal, pulmonologist and director of Wellness Home Clinic and Sleep Center, said that this medicine works by narrowing the blood vessels in the nose, reducing congestion. However, it can also affect blood vessels in other parts of the body, potentially causing a sudden increase in blood pressure.

They highlighted that this effect is particularly risky for individuals with existing heart disease. A sudden increase in blood pressure can result in serious complications, including heart failure and hypertensive emergency.

Dr. Mittal argued that for short-term relief from nasal congestion, such risks outweigh the benefits.

“A day or two of relief is not worth the potential harm to heart health,” Dr. Mittal said, suggesting safer alternatives including saline nasal sprays, steam inhalation, humidifiers and nasal steroid sprays.

Future implications for India

Oral phenylephrine is commonly available in India through OTC and prescription, in the form of Decold and Decold Total.

While it remains to be seen whether India will follow the FDA’s lead, Dr. Mittal believes removing oral phenylephrine from OTC drugs will be a positive step for public health.