Drug Safety Alert: IPC Issues Warning Regarding Adverse Effects By Amphotericin B and Carbimazole

Dec 6, 2024

Pharmacy Inspections & Drug Safety, Antimicrobial Resistance & Awareness, Regulatory Updates
Pharmacy Inspections & Drug Safety, Antimicrobial Resistance & Awareness, Regulatory Updates

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As part of its latest drug safety alert in November, the Indian Pharmacopoeia Commission (IPC) cautioned about the possibility of serious adverse drug reactions (ADRs) with the use of amphotericin B and carbimazole to warn healthcare professionals on their use.Key Findings:
1. Amphotericin B

  • Indication: indicated for severe fungal infections, visceral leishmaniasis, febrile neutropenia in cancer patients.

  • Adverse Reaction: hyperkalemia (excess potassium in the blood), perilous to life.

Amphotericin B acts mainly on ergosterol in the fungal cell membrane which results in cell death. Nevertheless, it considerably disturbs the balance of electrolytes, mandating a close monitoring of potassium levels in patients.2. Carbimazole:

  • Indication: Antithyroid medication used for thyrotoxicosis with emphasis on thyroid storm cases.

  • Adverse Effects: Associated with a rare but serious adverse effect of agranulocytosis which is very low white blood cells count leading to compromised immunity and also high chances of infections.

Carbimazole works by decreasing thyroid hormones (T3 and T4) production in the body, but may also cause bone marrow suppression hence regular monitoring of the blood counts is imperative.

IPC Recommendations:
The IPC has advised healthcare professionals to remain vigilant for suspected ADRs associated with these drugs and report them accordingly. All stakeholders, including patients and pharmacists, may use the following channels to report:

  • PvPI Helpline: 1800-180-3024 (Toll-free)

  • ADR Reporting App: "ADR PvPI" (on Android)

  • Online Forms: Accessible via the IPC website.

The alert emphasizes the importance of pharmacovigilance to safeguard public health and ensure safer therapeutic practices. With Amphotericin B and Carbimazole widely used across India, healthcare providers must closely monitor their administration and patient responses.
For pharmacists, this serves as a reminder to educate patients about potential side effects, ensure prescription validity, and highlight the importance of immediate medical attention in case of adverse reactions.

Pharmacy Inspections & Drug Safety
Antimicrobial Resistance & Awareness
Regulatory Updates
Pharmacy Inspections & Drug Safety
Antimicrobial Resistance & Awareness
Regulatory Updates

Drug Safety Alert: IPC Issues Warning Regarding Adverse Effects By Amphotericin B and Carbimazole

Dec 6, 2024

Pharmacy Inspections & Drug Safety, Antimicrobial Resistance & Awareness, Regulatory Updates
Pharmacy Inspections & Drug Safety, Antimicrobial Resistance & Awareness, Regulatory Updates

As part of its latest drug safety alert in November, the Indian Pharmacopoeia Commission (IPC) cautioned about the possibility of serious adverse drug reactions (ADRs) with the use of amphotericin B and carbimazole to warn healthcare professionals on their use.Key Findings:
1. Amphotericin B

  • Indication: indicated for severe fungal infections, visceral leishmaniasis, febrile neutropenia in cancer patients.

  • Adverse Reaction: hyperkalemia (excess potassium in the blood), perilous to life.

Amphotericin B acts mainly on ergosterol in the fungal cell membrane which results in cell death. Nevertheless, it considerably disturbs the balance of electrolytes, mandating a close monitoring of potassium levels in patients.2. Carbimazole:

  • Indication: Antithyroid medication used for thyrotoxicosis with emphasis on thyroid storm cases.

  • Adverse Effects: Associated with a rare but serious adverse effect of agranulocytosis which is very low white blood cells count leading to compromised immunity and also high chances of infections.

Carbimazole works by decreasing thyroid hormones (T3 and T4) production in the body, but may also cause bone marrow suppression hence regular monitoring of the blood counts is imperative.

IPC Recommendations:
The IPC has advised healthcare professionals to remain vigilant for suspected ADRs associated with these drugs and report them accordingly. All stakeholders, including patients and pharmacists, may use the following channels to report:

  • PvPI Helpline: 1800-180-3024 (Toll-free)

  • ADR Reporting App: "ADR PvPI" (on Android)

  • Online Forms: Accessible via the IPC website.

The alert emphasizes the importance of pharmacovigilance to safeguard public health and ensure safer therapeutic practices. With Amphotericin B and Carbimazole widely used across India, healthcare providers must closely monitor their administration and patient responses.
For pharmacists, this serves as a reminder to educate patients about potential side effects, ensure prescription validity, and highlight the importance of immediate medical attention in case of adverse reactions.

Share:

Pharmacy Inspections & Drug Safety
Antimicrobial Resistance & Awareness
Regulatory Updates
Pharmacy Inspections & Drug Safety
Antimicrobial Resistance & Awareness
Regulatory Updates