Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Metoprolol, Nebivolol, Olmesartan, Sulfasalazine

This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

In accordance with the drug safety alert, antihypertensive drug Metoprolol causes Hyponatraemia, a condition that occurs when the level of sodium in the blood is too low.

Furthermore, alert added Nebivolol which is used to treat high blood pressure and heart failure, is linked to Hyperkalaemia, a condition marked by an elevated level of the electrolyte potassium in the blood.

Olmesartan, an angiotensin receptor blocker (ARB) used to treat hypertension, was also mentioned in the drug safety alert as having the potential to cause muscle spasms and taste disorders.

Additionally, the alert noted that Sulfasalazine, which is widely used to treat inflammatory conditions like ulcerative colitis and rheumatoid arthritis (RA), can result in Visual Impairment.

Metoprolol, Nebivolol, and Olmesartan mentioned in the drug safety alert are antihypertensive drug. Metoprolol is a beta-blocker used in the treatment of hypertension and angina, and used to reduce mortality due to myocardial infarction. Metoprolol is used 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 cardiac heart failure (CHF).

Nebivolol is a racemic mixture of 2 enantiomers where one is a beta adrenergic antagonist and the other acts as a cardiac stimulant without beta adrenergic activity. It is used for the treatment of essential hypertension.

Olmesartan belongs to the angiotensin II receptor blocker (ARB) family of drugs. ARBs selectively bind to angiotensin receptor 1 (AT1) and prevent the protein angiotensin II from binding and exerting its hypertensive effects, which include vasoconstriction, stimulation and synthesis of aldosterone and ADH, cardiac stimulation, and renal reabsorption of sodium, among others.

Sulfasalazine is an anti-inflammatory drug structurally related to salicylates and other non-steroidal anti-inflammatory drugs. It is indicated for managing inflammatory diseases such as ulcerative colitis and rheumatoid arthritis (RA).

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that nebivolol can result in hyperkalemia, metoprolol can cause hyponatraemia, olmesartan can induce taste disturbances and muscle spasms, and sulfasalazine can result in visual impairment.

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

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of above suspected drugs.

Further, the safety alert added, “If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of 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).”