Pigmentation problems are common in aesthetic medicine. The controversial murine models suggested that hydroquinone could be a carcinogen, which was the basis for the proposed ban on over-the-counter sales.
The aesthetic dermatology community, the largest user of hydroquinone, strongly opposed the FDA’s action.
Research into botanicals and other agents as potential alternatives to hydroquinone has prompted by worldwide bans on the substance.
Pigmentary problems including post-inflammatory hyperpigmentation, dyschromia, and melasma are among the most common issues in aesthetic medicine, particularly in darker-skinned patients. Yet the threat of a ban from the FDA in 2006 put a cloud over the agent widely considered in the U.S. to be the gold standard for the treatment of these skin problems — hydroquinone.
Dyschromia, melasma, and post-inflammatory hyperpigmentation are among the most common problems see in patients with darker skin in aesthetic medicine. However, in 2006, the FDA’s threat of banning the agent hydroquinone cast doubt on its status as the industry standard for treating these skin conditions.
The controversial murine models that suggested hydroquinone could be a carcinogen and reports that linked the product to exogenous ochronosis were the basis for the proposed ban on its over-the-counter sales. The aesthetic dermatology community, which was the largest user of hydroquinone and was adamant in its assertion of the product’s safety, strongly opposed the FDA’s action. Despite the public comment period of four months, no regulatory action was take.
Jacob Levitt, M.D., who published a critical review of the existing literature, was one of those making the strongest argument against extrapolation of the mouse studies at the heart of the FDA’s concerns. However, the issue was never officially put to bed, and doctors and patients alike may be justified in wondering if hydroquinone remains on borrowed time in the United States. He suggests that previous studies’ descriptions of renal tumors were not applicable to humans because they were highly sex-, species-, and strain-specific. He came to the conclusion that even small amounts of hydroquinone applied topically to humans could not expected to cause murine leukemia.
According to Dr. Levitt, an assistant clinical professor of dermatology at the Mount Sinai Medical Center in New York, “the studies showed that the strain of rats that developed kidney problems also developed the problems independently, even without hydroquinone exposure, because they were genetically predisposed to do so, so it was unfair to link their tumors to hydroquinone.”
Data detour, he continues, “The studies could easily read to suggest the opposite with regard to the liver. They failed to prove a carcinogenic link.” It is true that hydroquinone exposure was associated with a slight rise in benign adenomas but a decrease in malignant liver carcinomas, suggesting that hydroquinone had a protective effect.” “Systemic exposure to hydroquinone from the routine topical application is no greater than that from quantities present in common foods,” he asserts in the end.
Dr. Levitt also looked into the FDA’s concern that hydroquinone might make people more likely to get ochronosis. He found that the incidence rate of ochronosis was very low when hydroquinone was use. “A literature review of exogenous ochronosis and clinical studies employing hydroquinone (involving over 10,000 exposures under careful clinical supervision) reveal an incidence of exogenous ochronosis in the United States of 22 cases in over 50 years,” Dr. Levitt noted in his paper.
It’s interesting to note that, rather than higher concentrations of hydroquinone, the majority of ochronosis cases find were associate with lower concentrations (2%, as opposed to 4% for prescription strength). This provides some support for limiting the product’s use to prescriptions under the supervision of a doctor and suggests that consumer overuse may be a problem.
Dr. Levitt explains, “The way dermatologists use hydroquinone is to use it for about three months and stop if it doesn’t work.” You will probably experience a plateau of effect after about six months, and you will also need to stop; However, there may be a problem if people use the product every day for ten or twenty years, so I could advocate keeping it on prescription only.” Dr. Levitt takes note of that before its proposition for the boycott, the actual FDA had proactively supported a hydroquinone-containing item, the melasma treatment Tri-Luma cream, an original effectiveness skin-containing retinoid (0.5 percent tretinoin), steroid (0.01 percent fluocinolone acetonide) and hydroquinone (4%).
