Hydroquinone falls under the category of medications considered Generally Recognized as Safe and Effective (GRASE) by the FDA. This category contains medications that have been in use since before the formation of the FDA (e.g. aspirin). These medications did not undergo the same rigorous clinical trials demonstrating safety and effectiveness that are required for new medications to be approved. In 2006, the FDA proposed that more research be done to determine the safety of hydroquinone because of two possible safety concerns:
- There is some evidence that hydroquinone could be a carcinogen. Studies done on rats and mice fed the animals large amounts of hydroquinone orally, and demonstrated increased rates of cancer. We don’t know how these studies apply to humans because hydroquinone is used in much smaller doses and is applied topically, not ingested.
- Ochronosis has been reported after topical use of hydroquinone. This is a condition where the skin becomes darker over time. It is fairly rare, and seems to be more common in darker skin tones. It also seems to occur after prolonged use of hydroquinone, i.e. several years. But there are no data available on how long hydroquinone can safely be used without increasing the risk of ochronosis.
The large majority of skin lightening creams available on the market contain hydroquinone. Because of above-mentioned concerns for safety, alternative products have been developed that do not contain hydroquinone. The most popular of these products is Lytera®, a skin brightening cream released by Skin Medica in 2013. Lytera® contains a proprietary blend of ingredients that work to even skin tone and lighten pigmentation, and in one clinical study it was shown to be as effective as hydroquinone in lightening skin pigmentation.
Skin Medical likes to advertise Lytera® as the only FDA-approved skin lightener shown to be as effective as hydroquinone. This statement is factually correct, but slightly misleading. Lytera® is FDA-approved as an over-the-counter (OTC) medication. OTC medications do not undergo the same stringent FDA-approval process as prescription medications. Instead, OTC medications are approved automatically as long as all of the ingredients they contain are already FDA-approved. The ingredients contained in Lytera® are listed on the website, and all of the key ingredients listed have previously been used in other OTC medications. So yes, Lytera® is FDA-approved. And yes, at least one clinical study has shown it to be as effective as hydroquinone. But that doesn’t mean it’s necessarily any safer than hydroquinone, which I will remind you is also FDA-approved.
So what’s the bottom line here? Skin lightening creams have been used for decades, and are generally recognized as safe. There is some data to suggest hydroquinone could have negative side effects, but no clinical trials in humans have ever been done. Non-hydroquinone products such as Lytera® are also available, but no proof exists that they are either more or less safe than hydroquinone. In the face of little data, you’ll just have to rely on your own judgement.
What do you think about hydroquinone- are you worried about negative side effects, or are you on the fence until we have more data?