The Indian Pharmacopoeia Commission (IPC) has flagged possible adverse reactions linked to three commonly used medicines, including an epilepsy drug and two nasal decongestants. The alerts aim to help the patients to recognise side effects early and avoid prolonged or inappropriate use of medicines.
The National Coordination Centre of the Pharmacovigilance Programme of India (PvPI), functioning under the IPC, has identified gingival hypertrophy, or abnormal enlargement of gum tissue, as a suspected adverse reaction associated with levetiracetam.
It has also flagged rebound nasal congestion linked to xylometazoline hydrochloride and oxymetazoline hydrochloride, commonly used in nasal drops and sprays to relieve a blocked nose.
The alerts do not mean that these medicines have been withdrawn or are unsafe for everyone. They signal suspected safety concerns that healthcare professionals need to monitor and report so that the risks can be assessed further.
Levetiracetam is an anti-epileptic medicine prescribed to control different types of seizures, including partial-onset, myoclonic and primary generalised tonic-clonic seizures. Since epilepsy often requires long-term treatment, the newly flagged gum-related reaction has implications for patients who take the medicine over extended periods.
Gingival hypertrophy refers to an abnormal increase in the size of gum tissue. Patients may notice swollen or enlarged gums, which can make brushing difficult and affect oral hygiene. If left unattended, the condition may contribute to discomfort and other dental problems.
The safety alert calls for greater attention to oral health among patients taking levetiracetam. Doctors and pharmacists should advise patients to watch for changes in their gums and seek dental assessment if swelling or enlargement develops. Routine oral examinations can help identify such changes early.
However, patients should not stop or reduce their anti-epileptic medication on their own. Interrupting epilepsy treatment without medical advice can increase the risk of seizures.
The second safety concern relates to xylometazoline and oxymetazoline, two commonly used ingredients in nasal decongestant drops and sprays. They work by narrowing blood vessels in the nasal lining, reducing swelling and temporarily making it easier to breathe.
The problem can arise when these products are used for longer than recommended. Instead of providing lasting relief, prolonged use can cause rebound congestion, in which the nose becomes blocked again, sometimes more severely, as the effect of the medicine wears off, according to a statement by the IPC.
Patients may mistake this recurring blockage for a persistent cold or allergy and use the spray repeatedly. This can create a cycle in which the medicine intended to relieve congestion begins contributing to the problem.
Prolonged use can lead to rhinitis medicamentosa, also known as drug-induced nasal congestion. The condition can cause persistent nasal blockage and make it difficult for patients to stop using the decongestant.
The IPC has advised healthcare professionals to counsel patients against using these nasal decongestants for more than five consecutive days. Those experiencing persistent nasal blockage should be evaluated rather than repeatedly reaching for the spray.
The three safety signals highlight two different concerns. In patients taking levetiracetam, an adverse reaction may go unnoticed unless oral health is monitored. With nasal decongestants, inappropriate or prolonged use can worsen the very symptom patients are trying to relieve.
The IPC has also urged doctors, pharmacists and patients to report suspected adverse drug reactions through the PvPI portal, its mobile application or the toll-free helpline.
