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

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-04-14T18:00:06+05:30  |  Updated On 14 April 2024 6:00 PM IST
Drug Safety Alert: IPC Flags ADR Linked To Cefuroxime, Nimesulide, Dutasteride plus Tamsulosin and some Beta-blockers
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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;

S. No.

Suspected Drugs

Indications

Adverse Drug Reactions

1

Cefuroxime

Antibiotic- Indicated for lower & upper respiratory tract infection, Urinary Tract Infection (UTI), gynecological infection, skin or soft tissue infection, etc.

Acute Generalized Exanthematous Pustulosis (AGEP)

2

Dutasteride + Tamsulosin

In the treatment of Benign Prostatic Hyperplasia

Palpitation

3

Nimesulide

  • Use in Inflammatory conditions including joint disorders such as rheumatoid arthritis, post-traumatic and post-operative painful conditions, and fever.
  • Acute pain in Orthopaedic, ENT, Dental, and Post Operative conditions.
  • Additional indication; for short treatment of adult patients with inflammation & pain associated with arthritis, soft tissue, ENT condition, trauma, dental pain, Musculo skeletal & gynecology & obstetric painful condition.
  • For the treatment of pyrexia and inflammatory conditions in livestock

Fixed Drug Eruption (FDE)

4

Beta-blockers (Metoprolol, Propranolol, Atenolol)

Metoprolol: 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.

Propranolol: Cardiac arrhythmias; tachycardia; hypertrophic obstructive cardiac myopathy; pheochromocytoma; thrombosis; management of angina; essential and renal hypertension; prophylaxis of migraine.

Atenolol: For the treatment of hypertension, angina pectoris, cardiac arrhythmias

Erectile dysfunction (Reversible)

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:

https://medicaldialogues.in/pdf_upload/drugsafetyalertsmarch2024-236152.pdf
Indian pharmacopeia commissiondrug safety alertadverse drug reactioncefuroximeDutasteridetamsulosinnimesulideatenololmetoprololpropranololPvPIErectile dysfunction
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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