Drug Safety Alert: Indian Pharmacopoeia Commission flags Adverse Reactions linked to Minoxidil

This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Minoxidil is an orally effective direct acting peripheral vasodilator that reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. Minoxidil is also used topically to treat androgenetic alopecia.

In accordance with the notice, Minoxidil is indicated for the treatment of alopecia (male pattern baldness in men).

Minoxidil is thought to promote the survival of human dermal papillary cells (DPCs) or hair cells by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of BCl-2/Bax. Minoxidil may stimulate the growth of human hairs by prolonging anagen through these proliferative and anti-apoptotic effects on DPCs.

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Minoxidil can lead to Folliculitis.

Folliculitis is a common skin condition that happens when hair follicles become inflamed. It's often caused by an infection with bacteria. At first it may look like small pimples around the tiny pockets from where each hair grows (hair follicles). Folliculitis can result in painful skin inflammation, sores, and pimple-like bumps.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:

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 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)."