Here's what to know about pholcodine (representative image) (Source: Pixabay)
Following the World Health Organization (WHO)’s safety concern alert regarding pholcodine use in cough syrups issued in March 2023, The Drugs Controller General of India (DCGI) has issued an advisory, dated July 14, for medical professionals and patients to stop its use with immediate effect.
According to WHO, there is a heightened risk of anaphylactic reactions in people who have taken pholcodine-containing cough syrups and cold remedies at least 12 months prior to surgical procedures involving the administration of general anaesthesia with neuromuscular blocking agents (NMBAS). As such, DCGI has asked medical doctors to advise patients to stop taking pholcodine-containing cough syrups and cold remedies and suggest an alternative to treat their symptoms.
Additionally, the notification reads, “To verify whether the patients schedule to take general anaesthetics containing (NMBAS) have taken pholcodine-containing cough syrups in the previous 12 months and also be aware of anaphylactic reactions in such patients.”
It further advised consumers to be wary of its use and seek alternative treatments, and report any prior usage to the concerned doctor before undertaking any surgery procedures.
Pholcodine containing cough syrups and cold remedies at least 12 months prior to surgical procedures are harmful, states WHO (Source: Pexels)
Pholcodine is an antitussive, antitussive is a group of drugs that leads to suppression of the cough. So, in other words, it is a cough suppressant which is an opioid derivative. It acts by depressing the cough center in the brain. “Pholcodine is an opioid cough suppressant that works selectively on the cough center of the brain to control and help stop coughing. It works by binding various opioid receptors in a part of the brain responsible for triggering the cough reflex,” said Dr Shrey Srivastav, MD (Internal Medicine), Sharda Hospital, Noida.
Why is it harmful?
Pholcodine has been used in adults and children to treat non-productive (dry) cough and is most commonly used in cough syrups and lozenge products. It has also been used in combination with other active substances in products that treat the symptoms of cold and flu, states Therapeutic Goods Administration (TGA) on its website. Recently, TGA recalled products containing pholcodine because of life-threatening conditions interacting with neuromuscular blocking agents during surgery.
According to Dr Saurabh Khanna, lead consultant, paediatrics and neonatology, CK Birla Hospital Gurugram, it is harmful if it is used excessively in inappropriate doses at an age that is not at the age of recommendation. “Ideally, it is recommended only for children who are more than six years of age or for adults who have severe cough episodes. It is added to the cough syrup because it gives an added advantage to them by suppressing the cough center in the brain. The use of antitussives should be restricted to only times when the cough is very severe, and it is not associated with any other risk factors,” Dr Khanna told indianexpress.com.
“According to WHO, it can trigger life-threatening anaphylactic allergic reactions if people are given specific muscle relaxant drugs while under a general anaesthetic. That risk of anaphylaxis can remain for weeks and months after taking the cough medicine. The most common side effects of pholcodine are dizziness, nausea, and sedation,” said Dr Srivastav.
Administration of pholcodine causes the production of antibodies in the person. “These antibodies cause anaphylactic reaction with NMBAS and are administered during general anaesthesia (to prevent the patient from moving during surgery). These antibodies increase the risk of anaphylaxis with NMBAS by 300 times. The other concern is that these antibodies could remain in circulation for several years,” said neurologist Dr Sudhir Kumar, Apollo Hospitals Hyderabad.
Dr Kumar informed that pholcodine replaced codeine (which was commonly added to cough syrups a few decades back). This replacement was mainly done to reduce the risk of dependence, which is common with codeine, but much less commonly seen with pholcodine, mentioned Dr Kumar.
Its use has been quite prevalent in India, asserted Dr Khanna. “It is used in most of the cough syrups available over the counter. One has to ensure that whenever buying a cough syrup, you should get the prescription written by a healthcare professional, a pediatrician, or an MD medicine person so that you give it in an appropriate dose only if it is required,” said Dr Khanna.
Not all cough requires syrups. experts urge (Source: Getty Images/Thinkstock)
Suggestion to healthcare providers
*Avoid using cough remedies that contain pholcodine. “If it has to be used, then inform the patient of the risk of a severe allergic reaction if undergoing surgery under general anaesthesia using NMBAs,” said Dr Kumar.
Suggestion to the general public
*If using any cough syrup, check the contents to see if it contains pholcodine. “If undergoing any surgery, inform to the doctors and nurses, if one has consumed cough remedies containing pholcodine in the previous 12 months,” said Dr Kumar.
The bottom line is cough suppressants are only to be used in case of specific indications. “Every cough should not be treated by using pholcodine because this is only symptomatic treatment, and it does not treat the root cause of the cough,” urged Dr Khanna.
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