Indian Journal of Pharmacology Medknow Publications on behalf of Indian Pharmacological Society ISSN: 0253-7613 EISSN: 1998-3751 Vol. 42, Num. 6, 2010, pp. 422-422

Indian Journal of Pharmacology, Vol. 42, No. 6, November-December, 2010, pp. 422

Letter to the Editor

Echinocandins: A ray of hope in antifungal drug therapy

Neeta D Grover

Department of Pharmacology, Bharati Vidyapeeth University Medical College and Hospital, Sangli, Maharashtra, India

Correspondence Address:
Neeta D Grover
Department of Pharmacology, Bharati Vidyapeeth University Medical College and Hospital, Sangli, Maharashtra
India
neetadhargrover@hotmail.com

Code Number: ph10124

DOI: 10.4103/0253-7613.71906

Sir,

I would like to thank the respondents for expressing an interest in the article. ^[1] They have raised two important issues.

1. Micafungin was approved for pediatric patients, including neonates, for prophylaxis of candidial infections in patients undergoing HSCT and in those with invasive candidiasis in Japan and the European Union. I have shown only the USFDA-approved indications in the study. ^[2] The drug regulatory authority in the USA (USFDA) does not permit the use of micafungin in the pediatric population. ^[3] However, the European Medicines Agency or EMEA permits the use of micafungin in the pediatric population. ^[4] As per the latest available information, micafungin is still not approved for pediatric population by the USFDA, due to limited experience. This discrepancy between the USFDA and the EMEA is not a first time occurrence, especially in the area of antimicrobials. ^[5]
2. As far as its being an alternative to fluconazole, in the case of prophylaxis in the preterm neonates, even the EMEA cautions against the use of micafungin, if an acceptable alternative is available. This is due to a suspected risk of hepatic tumors seen as foci of altered hepatocytes (FAH) in animal studies, which did not get reversed on stopping the drug, but developed into tumors. Moreover, the incidence of derangement of hepatic transaminases was significantly higher in the pediatric age group in clinical trials. The hepatic adverse events are highest in the below 1 year age group. ^[4],[6] While granting marketing authorization, the Committee for Human Medicinal Products (CHMP) concluded that due to a potential risk of the development of hepatic tumors, the benefit/risk ratio of all other applicable antifungals is considered "superior" to micafungin. ^[7] It may, of course, be a matter of time before the drug is approved for use in the pediatric population in the United States.

References

1.	Gonzalez-Granado L. Very-low-birth-weight infants, prophylactic micafungin or fluconazole. Indian J Pharmacol 2010;42:422.  Back to cited text no. 1
2.	Grover ND. Echinocandins: A ray of hope in antifungal drug therapy. Indian J Pharmacol 2010;42:9-11.  Back to cited text no. 2  [PUBMED]
3.	Mycamine.Summary of Product Characteristics as provided by Astellas Pharma Ltd. Available from: http://www.emc.medicines.org.uk [last updated on 2009 Dec 3]. [last accessed on 2010 Apr 26].  Back to cited text no. 3
4.	European Medicines Agency. Mycamine European Public Assessment Report: Scientific discussion; April 2008. Available from: http://www.emea.europa.eu [last accessed on 2010 Apr 26].  Back to cited text no. 4
5.	Pappas G, Lerodiakonou V, Falagas ME. Lost in translation: Differences in antimicrobial indication approval policies between the United States and Europe. Clin Ther 2009;31:1595-603.  Back to cited text no. 5
6.	Carter NJ, Keating GM. Micafungin: A review of its use in the prophylaxis and treatment of invasive Candida infections in pediatric patients. Pediatr Drugs 2009;11:271-91  Back to cited text no. 6
7.	King KY, Edwards MS, Word BM. Hepatitis associated with micafungin use in a preterm infant. J Perinatol 2009;29:320-2.  Back to cited text no. 7  [PUBMED]  [FULLTEXT]

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