IPC Flags Suspected Adverse Reactions Linked to Levetiracetam, Xylometazoline, Oxymetazoline
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its Drug Safety Alert has flagged suspected adverse drug reactions indicating that the antiepileptic drug Levetiracetam may be associated with gingival hypertrophy, while the nasal decongestants Xylometazoline and Oxymetazoline may be linked to rebound nasal congestion.
In connection with these findings, the IPC, under the Ministry of Health and Family Welfare, has advised healthcare professionals and patients to remain vigilant and closely monitor the occurrence of these suspected adverse drug reactions (ADRs) during treatment.
The alert follows an analysis of ADR reports available in the Pharmacovigilance Programme of India (PvPI) database, which identified the above safety concerns.
Levetiracetam is used in the treatment of epilepsy. The alert lists its indications as monotherapy for partial-onset seizures, with or without secondary generalisation, in patients aged 16 years with newly diagnosed epilepsy, and as adjunctive therapy for specified seizure types.
The listed adjunctive uses include myoclonic seizures in adults and adolescents from 12 years of age. The alert also mentions partial-onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures in adults with idiopathic generalised epilepsy among the indications for adjunctive treatment in patients aged 16 years and older.
Based on the analysis of reports in the PvPI database, the IPC has flagged gingival hypertrophy, or enlargement of the gums, as a suspected adverse reaction associated with Levetiracetam.
Xylometazoline and Oxymetazoline, on the other hand, are indicated as nasal decongestants. The safety alert identifies rebound nasal congestion as the suspected adverse reaction associated with their use.
S. No. | Suspected drugs | Indication(s) | Adverse drug reactions |
1 | Levetiracetam | As monotherapy in partial onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile. As adjunctive therapy in adult (16 years and older) with the following types of seizures: 1. Partial onset seizures 2. Myoclonic seizures in patients with juvenile myoclonic epilepsy 3. Primary generalized TonicClonic seizures in adults with idiopathic generalized epilepsy. | Gingival hypertrophy |
2 | Xylometazoline/Oxymetazoline | Nasal decongestant. | Rebound nasal congestion |
In light of the findings, the IPC has urged healthcare professionals and patients to closely monitor for these suspected adverse reactions and report any cases encountered to the National Coordination Centre (NCC)-PvPI at the IPC.
Healthcare professionals can submit the Suspected Adverse Drug Reactions Reporting Form, while consumers can use the Medicines Side Effect Reporting Form, both available through the official IPC website.
The alert also lists the PvPI Helpline No. 1800-180-3024, the PvPI Mobile App 2.0, available on the Google Play Store, and the Adverse Drug Reaction Monitoring System (https://adrmsipc.in/adrms/index.html)as reporting channels.
To view the official notice, click the link below:
