Minoxidil lotion over the counterBMJ 1995; 311 doi: https://doi.org/10.1136/bmj.311.7004.526 (Published 26 August 1995) Cite this as: BMJ 1995;311:526
Hair today and hair tomorrow--but at the price of continuous treatment
On the advice of the Committee on the Safety of Medicines, the Medicines Control Agency removed the prescription only label from 2% minoxidil lotion and made it available over the counter from pharmacies in January 1995. But it is still not available on prescription from the NHS.
Once Upjohn has prepared its product for marketing direct to the public, patients will no longer need to badger their general practitioner for private prescriptions. How many hours our general practitioners will save and how much income they will lose are unknown, but those plagued by patients for this drug for male and female baldness will no doubt be relieved.
The discovery that oral minoxidil induces widespread hirsutism was entirely serendipitous. The mechanism is still obscure, but the logic of seeking a local effect soon followed. Publications in the late 1980s reported regrowth of non-vellus hair in half the subjects of both sexes with androgenetic alopecia1; in only 8% was it reported as dense. “Fastidious compliance with twice daily application” seven days a week is essential. A result is apparent only after four months or more, and, sadly, any new hair falls out two months after treatment is stopped.2 The same review states that “minoxidil has a significant stabilising effect on the retention of hair in most men with male baldness,” and in women “minoxidil seems to stabilise loss consistently.”
Curiously, at least one study has reported an unexplained improvement in growth of non-vellus hair--over half of that noted in test subjects--in subjects using just the vehicle.3 Was massage acting as a remedy? The drug is dissolved in an aqueous alcohol solution with added propylene glycol to enhance absorption. This makes it irritant and almost drinkable, though at £30 for 60 ml--a month's treatment--it is rather expensive for use even in a cocktail. Because about 1.4% of the dose is absorbed systemically there were fears of hypotension or interference with concomitant antihypertensive treatment. But the risk has proved so small that the committee was presumably prepared to ignore it. Is that wise?
The original studies of side effects were carried out in normotensive subjects. Apart from irritant and allergic reactions to the topical preparation, cardiovascular side effects, such as oedema and hypotensive symptoms, were as common in the study group as in subjects given a placebo. Nevertheless, those of us who tried the preparation on our patients in its early days have anecdotal evidence of hypotensive episodes. This may have been because we warned the patients that this might happen. Lawyers expect doctors to tell every patient of all the possible side effects of a drug; so patients will eventually report every one of them, however bizarre.
What happens when the drug is used by hypertensive patients, those with angina, or those taking hypotensive drugs? Although the leaflet accompanying the bottle will give all the warnings and precautions, how certain can we be that users will read them and then heed them? What uses other than as a hair restorer are likely? One recent paper reports the drug's (unsuccessful) use in male erectile dysfunction.4
Over the counter status means that manufacturers can now market their product direct to the public, with no need to press the scientific case on general practitioners and dermatologists. Previously, Britain's Advertising Standards Authority seems to have turned almost a blind eye to the cosmetic industry's extravagant and emotive claims for topical remedies for dry skin, greasy skin, aging skin, wrinkles, dry hair, greasy hair, mottled skin, and even “cellulite.” The industry's promises that products will preserve and restore users' bodies so that they look like the perfect nudes in the advertisements frequently astonish critical dermatologists. It would be disturbing if a similar onslaught was launched on the millions with falling hair.
Should the emphasis be on regrowth, “customers” will have to spend at least £120 before realising the lotion's benefit because improvement takes four months or more to become apparent. Users are advised to give up if no benefit is obtained after a year, after having spent £360. Those convinced by the lotion's efficacy will need to continue its use for life. On the other hand, if its value as a stabiliser preventing further hair loss is emphasised, who would be churlish enough to deny their scalp the benefit? The drug could net its manufacturers many millions.