Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Beta blockers

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of December, has revealed that cardiovascular drug beta-blockers (metoprolol, propranolol, and atenolol) may lead to adverse drug reactions (ADRs) named hypokalaemia.

In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering beta-blockers such as metoprolol, propranolol, and atenolol.

This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Beta blockers are a class of medications that are predominantly used to manage abnormal heart rhythms (arrhythmia) and to protect the heart from a second heart attack after a first heart attack (secondary prevention). They are also widely used to treat high blood pressure, although they are no longer the first choice for initial treatment for most people.

Beta blockers are competitive antagonists that block the receptor sites for the endogenous catecholamines epinephrine (adrenaline) and norepinephrine (noradrenaline) on adrenergic beta receptors of the sympathetic nervous system, which mediates the fight-or-flight response.

Metoprolol is a beta-blocker used in the treatment of hypertension and angina and used to reduce mortality due to myocardial infarction. Metoprolol is indicated for the treatment of essential hypertension in adults, functional heart disorders, migraine prophylaxis, cardiac arrhythmias, prevention of cardiac death and reinfarction after the acute phase of myocardial infarction, stable symptomatic CHF, and angina pectoris.

Propranolol is a non-selective beta-adrenergic antagonist used to treat hypertension, angina, atrial fibrillation, myocardial infarction, migraine, essential tremor, hypertrophic subaortic stenosis, and pheochromocytoma.

Propranolol is indicated for the treatment of cardiac arrhythmias, tachycardia, hypertrophic obstructive cardiac myopathy, pheochromocytoma, thrombosis, management of angina, essential and renal hypertension, and prophylaxis of migraine.

Atenolol is a synthetic beta-1 selective blocker used in the management of hypertension and chronic angina and to reduce mortality in known or suspected myocardial infarction in hemodynamically stable patients. Atenolol is indicated for the treatment of hypertension, angina pectoris, and cardiac arrhythmias.

Following the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it is reported that beta-blockers such as metoprolol, propranolol, and atenolol can lead to hypokalaemia.

Hypokalaemia, or low potassium, is a condition where there are lower than normal levels of potassium in the blood. Potassium is important for the proper functioning of muscles and nerve cells, especially in the heart.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADR, as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised healthcare professionals, patients, and consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC, by filling out the Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (toll-free).

To view the official notice, click the link below: