11 December 2002
From:
Sent: Wednesday, 6 November 2002 14:57
Subject: Re: Paediatric ibuprofen for Essential Medicines List
Dear Dr. Gray,
Thank you for your e-mail. With our limited knowledge, and based on the application document attached, we have these following comments:
1.) Lack of appropriate prescribing dosage for the indications mentioned (analgesic and antipyretic). Dosage should ideally be based on weight, and the medication should be administered with an appropriate measuring device. For example, ibuprofen has an antipyretic and anti-inflammatory effect in children at a dose of 5-10 mg/kg (maximum daily dose 40 mg/kg per day) and is given on a every 6 to 8 hours schedule.
2.) Appropriate attention to the concentrations of various liquid products is important to ensure safe dosing.
3.) Should be more specific on the recommend of duration of treatment. In the application, it mentioned only short-term use. Non-prescription analgesics are indicated for self-treatment of mild to moderate pain and should be taken no longer than 7-10 days. When these products are used as antipyretics, use should generally be limited to three days.
4.) When non-prescription analgesics are appropriate, drug selection should take into account not only the comparative safety and efficacy of available drug products but also available dosage forms and costs of therapy.
5.) The indication of age group has to be clearly indicated. Due to lack of- insufficient clinical experience, it is not labelled for use in children under the age of two.
6.) We have to be very careful with the statement in the application: Quote: " Furthermore, the wide therapeutic index of ibuprofen confers an advantageous safety profile in overdose when compared to paracetamol" Unquote.
Even the safest drug can do harm when prescribed or ingested without regard to appropriate safeguards. In a recent clinical trial involving 55,785 children receiving ibuprofen revealed few serious adverse effects. Based on their patient population, the authors estimated a risk of 5.4 per 100,000 patients for the development of acute renal failure, anaphylaxis, or Reye's syndrome. Until adverse event data collected over a period of years prove conclusively that rare serious events are not associated with ibuprofen, the above statement should not be promoted.
Best regards,
Thuy Huong Ha
Technical Officer UNICEF Supply Division
Copenhagen
References:
1.)" ASHP Therapeutic Position Statement on the Safe Use of Oral Nonprescription Analgesics" 1999. American Society of Health-System Pharmacist Inc.
2.) "Acetaminophen and Ibuprofen in the Management of Fever and Mild to Moderate Pain in Children". 3.) "Making sense of Over the Counter Relievers" American Council on Science and Health.
4.) Therapy Review: Antipyretics. Volume 2, number 7, July 1996. Pediatric Pharmacotherapy.
5.) "Alternating Antipyretics: Is this an alternative?". Clara E. Mayoral, Ronald V. Marino, Warren Rosenfeld, Joseph Greensher. Pediatrics. Volume 105. Number 5. May 2000. American Academy of Pediatrics.