IPC flags drug safety alert against Minoxidil due to adverse event known as folliculitis
The Indian Pharmacopoeia Commission (IPC) has flagged drug safety alert to the Drugs Controller General of India (DCGI) revealing that Minoxidil is associated with adverse event known as folliculitis. IPC is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).Minoxidil topical solution has been approved in India for the treatment of hair loss in men. It has also been authorised by the US Food and Drug Administration (FDA) for the treatment of hair loss in both men and women.Folliculitis is often caused when hair follicles are infected with bacteria like Staphylococcus aureus (staph). It may also be caused by viruses, fungi, parasites, medications or physical injury. However healthcare practitioners say that Minoxidil does not cause folliculitis. Scalp has to be examined and proper diagnosis has to be done for further treatment.Dr. Reddy’s Laboratories had launched the prescription drug Minoxidil topical solution USP 2% and 5% for the treatment of female pattern hair loss (FPHL) in September 2021 under the brand names Mintop 2% and Mintop Eva 5% respectively.The DCGI had given the first-ever approval for the use of Minoxidil topical solution USP 2% and 5% for the treatment of female pattern hair loss (FPHL) in India.Minoxidil topical solution is available as a first-line treatment option for FPHL in India. While Minoxidil topical solution has been approved in India for the treatment of male pattern baldness, there are presently no other drugs approved for the treatment of FPHL.Female pattern hair loss is the most common cause of hair loss in women and its prevalence increases with advancing age, often leading to psychological distress.The launch follows the first-ever approval of the additional indication by the Central Drugs Standard Control Organization (CDSCO) in India for the use of Minoxidil topical solution USP 2% and 5% for treatment of FPHL.Minoxidil topical solution will become available as first-line treatment option for FPHL in India. While Minoxidil topical solution has been approved in India for the treatment of alopecia in men (male pattern baldness), there were no other drugs approved for the treatment of FPHL in India.PvPI was implemented by the CDSCO in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.
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