Cough syrups containing chlorpheniramine maleate have been restricted for sale, manufacture, and distribution
India’s top drug controller has banned an anti-cold drug combination for use in children below the age of four, citing safety and health concerns. According to a report in the Times of India, cough syrups containing chlorpheniramine maleate and phenylephrine hydrochloride that help relieve itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold been restricted for sale, manufacture, and distribution.
The Drugs Technical Advisory Board and Subject Expert Committee examined the fixed-dose combination, or FDC, of these syrups and have subjected them to a condition that the manufacturers will mention the warning that it “shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug.
The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark, T-Minic sold by Haleon (formerly GlaxoSmithKline), and Maxtra (Zuventus Healthcare), among others.
"The central government is satisfied that it is necessary and expedient in the public interest to regulate, by way of restriction, the manufacture for sale and distribution for human use of the said drug in the country," the notification read.
Last year, the US Food and Drug Administration proposed the removal of oral phenylephrine as an active ingredient in over-the-counter medications for nasal congestion relief after they found it was ineffective.
How does chlorpheniramine relieve cold and cough symptoms?
Chlorpheniramine maleate works by blocking the action of histamine, thereby relieving these symptoms.
Common side effects of Chlorpheniramine Maleate
While less common, the most serious side effects of chlorpheniramine are described below, along with what to do if they happen. Chlorpheniramine may lead to allergic reactions, which can be serious. Stop taking chlorpheniramine and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Dryness in mouth
- Sleepiness
- Nausea
- Headache
- Sedation
- Difficulty in paying attention
- Trouble swallowing or throat tightness
-
Swollen lymph nodes
- Swelling on the face, lips and mouth
- Impaired coordination
- Dizziness
- Stomach cramps
- Joint pain
- Blurred vision
-
Fatigue and tiredness
In a few children, there are also rampant reports of chlorpheniramine making it harder to empty the bladder, especially if there is a blockage.
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