Drug Safety Alert: IPC Flags ADR Linked To Cefuroxime, Nimesulide, Dutasteride plus Tamsulosin and some Beta-blockers

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert, has revealed adverse drug reactions linked with the popular antibiotic Cefuroxime, fixed-dose combination drug Dutasteride plus Tamsulosin, non-steroidal anti-inflammatory drug Nimesulide, and beta blockers such as Metoprolol, Propranolol, Atenolol.

In accordance with the drug safety alert, Cefuroxime which is an antibiotic, indicated for lower and upper respiratory tract infections, urinary tract infections (UTI), gynecological infections, and skin or soft tissue infections, etc can cause Acute Generalized Exanthematous Pustulosis (AGEP).

Acute generalized exanthematous pustulosis (AGEP) is a rare, acute eruption characterized by the development of numerous nonfollicular sterile pustules on a background of edematous erythema.

The warning also stated that palpitations may occur from the fixed-dose combination medication Tamsulosin + Dutasteride, which is used to treat benign prostatic hyperplasia. Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older.

In addition to the aforementioned, the warning claimed that the non-steroidal anti-inflammatory medication nemesulide may cause fixed drug extinction (FDE). A fixed-drug eruption (FDE) is a unique cutaneous adverse drug effect in the form of recurrent lesions at the same site after re-exposure to the offending agent.

Nemesulide is used in Inflammatory conditions including joint disorders such as rheumatoid arthritis, post-traumatic and post-operative painful conditions, fever, and acute pain in Orthopaedic, ENT, Dental, and post-operative conditions. Additional indications of nimesulide include short treatment of adult patients with inflammation and pain associated with arthritis, soft tissue, ENT condition, trauma, dental pain, Musculo skeletal and gynecology, and obstetric painful conditions. It is also used for the treatment of pyrexia and inflammatory conditions in livestock.

Furthermore, the alert cited a link between reversible erectile dysfunction and beta blockers such as metoprolol, propranolol, and atenolol.

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, and stable symptomatic CHF. Propranolol is indicated for cardiac arrhythmias; tachycardia; hypertrophic obstructive cardiac myopathy; pheochromocytoma; thrombosis; management of angina; essential and renal hypertension; and prophylaxis of migraine. Atenolol is used for the treatment of hypertension, angina pectoris, and cardiac arrhythmias.

In line with the drug safety alert beta-blockers such as Metoprolol, Propranolol, and Atenolol can cause reversible erectile dysfunction.

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

The analysis of Adverse Drug Reactions (ADRs) from the PvPI database revealed the following;

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 the 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)."

To view the official notice, click the link below: