3 days Ago
Listen to Story The Food and Drug Administration (FDA) - top US drug regulator - has proposed removing oral phenylephrine, a common ingredient in many over-the-counter (OTC) cold and cough medicines, stating that it is not effective in relieving nasal congestion. The proposal, announced last month, came after an expert panel unanimously voted last year that oral phenylephrine does not work as intended and no further trials are needed to confirm this. 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. This happened after companies such as Procter & Gamble and UK pharmaceutical giant GSK were among several accused in lawsuits of deceiving consumers about cold medicines containing the ingredient. The FDA is now seeking public feedback on this proposal.
Until a final decision is made, manufacturers can continue selling products containing oral phenylephrine. However, the agency assured that drugmakers would be given enough time to either reformulate their products or remove them from the market if the proposal is finalised. Health Concerns Around Oral Phenylephrine There are several health concerns linked to oral phenylephrine which is the reason behind FDA's proposal to ban this ingredient in various common cold formulations.
Dr Vikas Mittal, Pulmonologist and Director at Wellness Home Clinic and Sleep Centre, explained that the drug works by constricting blood vessels in the nose, reducing congestion. However, it can also affect blood vessels in other parts of the body, potentially leading to a sudden rise in blood pressure. He highlighted that this effect is especially risky for individuals with existing heart conditions.
A sudden spike in blood pressure can result in serious complications, including heart failure and hypertensive emergencies. Dr Mittal argued that for short-term relief from nasal congestion, such risks outweigh the benefits. "One or two days of relief is not worth the potential harm to heart health," Dr Mittal, 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, both OTC and through prescriptions, in medications like Decold and Decold Total. While it remains to be seen if India will follow the FDA's lead, Dr Mittal believes that removing oral phenylephrine from OTC medications would be a positive step for public health..
