The Indian Pharmacopoeia Commission (IPC) has expressed its concern over adverse drug reactions (ADRs) caused by widely used life-saving beta blockers, such as metoprolol, propranolol, and atenolol, which are commonly prescribed for heart disorders and migraines.

Key Highlights

1. Adverse Drug Reactions (ADR):

2. ADRs are harmful, unintended effects caused by medications, potentially resulting from a single dose, prolonged use, or drug combinations.

3. IPC analysis of the Pharmacovigilance Programme of India (PvPI) database has found these beta blockers cause hypokalaemia, which is a dangerous condition as it results from the deficiency of potassium.

  2.  Medical Use of Beta Blockers:

• Beta blockers are used in the treatment of hypertension, cardiac arrhythmias, angina, functional heart disorders, and migraine prevention.

  3.  Market Size and Impact:

• Indian beta blocker market is $11.06 billion and expected to reach $15.08 billion by 2030.

• India is one of the leading manufacturers of pharmaceutical products and has a strong pharmacovigilance system in place to monitor the safety of marketed drugs.

  4.  Health Advisory:

• Healthcare professionals, patients, and consumers should be alert and observe hypokalaemia symptoms when taking these drugs.

• They should report adverse reactions to the IPC for further assessment.

Expert Insights and Recommendations:

1. Potential Risks:

Hypokalaemia, associated with beta blockers, can manifest as muscle weakness, fatigue, irregular heart rhythms, and, in severe cases, paralysis or life-threatening complications.  2.  Call for Vigilance:
The IPC advises healthcare professionals and patients to remain vigilant and report any ADRs to ensure timely regulatory action.  3.  India’s Pharmacovigilance Strength:
During this period, IPC works with CDSCO to ensure safe pharmaceutical practices. Between March and December 2024, IPC detected ADRs for 13 drugs including beta blockers.The alert for beta blocker drugs requires awareness and proactive reporting of adverse reactions. The healthcare providers and patients must be very careful with their use so that no life-threatening complications may arise, and safer medication practices may be preserved.