When one thinks about the dangers of prescription drug abuse, many things may come to mind – mostly in the realm of highly recognized addictive pain killers and other mood altering substances. The thought of drug abuse from topical skin care definitely is not one of the issues likely to be cited – at least, not historically.
But there are a growing number of regulatory agencies and medical professionals mounting an effort to change that. The issue they are calling attention to, is one where increasingly, and usually quite unknowingly, consumers around the country and world are using prescription level skin bleaching substances such as hydroquinone, in skin lightening creams that are marketed as if they were your average daily skincare lotion.
Is it safe to use hydroquinone daily for life? Not at all – according to a study entitled, “Widespread Use of Toxic Skin Lightening Compounds: Medical and Psychosocial Aspects“ published in the peer-reviewed journal publication “Dermatologic Clinics”. Published within the last two years, that study summarizes the side effects and irreversible skin damage resulting from the use of ingredients commonly found in skin lightening products using hydroquinone. Side effects that include minor rashes and scaly skin, to more serious conditions over long term use, including hypo-pigmentation (permanent loss of skin color in patches of skin), decreased skin elasticity, yellowing of the nails, discoloration of the eyes, and impaired wound healing.
Other studies have indicated an unconfirmed possibility of skin cancer, linking hydroquinone to carcinogenic modes of action based on studies using rats. Moreover, other studies have documented that hydroquinone (which is known as a benzene compound) can absorb into the marrow of the bone, possibly linking it to acute myelogenous leukemia, a cancer of the bone marrow and the white blood cells produced in the marrow. So if hydroquinone is so bad, why isn’t it banned from cosmetic skincare products? Well actually – it is banned from cosmetics throughout Europe and several other countries worldwide. That is precisely what the FDA has proposed to do here in the United States, though they have not yet put that ruling into action, and it is hard to say if or when they will. In the meantime, hydroquinone is at least limited, to no more that 2% in cosmetic products.
However, many believe that this limit is not helpful, because it is arguably easier to find a 4% hydroquinone product for sale without a prescription online, than it is to find a 2% hydroquinone product. Looking to change that and tired of waiting for FDA action, certain state enforcement agencies have taken matters into their own hands. Most notably, in the state of Texas, the attorney general took action against individuals and companies selling 4% hydroquinone over the internet in early 2011. They also confiscated Obagi products with hydroquinone from medical spas and other physician run operations in the Dallas/Fort Worth area. They could do that because technically the law prohibits anyone, even doctors, from selling prescription medications directly to the public and outside of the pharmacy prescription process. But some close to the situation seem to think their greater concern is with the marketing of hydroquinone as if it were a daily skincare product rather than a prescription medication. The makers of the Obagi product have recently announced that they have resolved their issues with the state of Texas, and would slowly begin selling to physicians in the state, while new inquiries from regulators in California are ongoing.
What new restrictions, if any, being placed on those physicians operating retail and online shops is not clear. Nor is it clear how they will address the potential problems that result from people buying hydroquinone products online, or picking them off the shelf of a retail section at their local spa, that currently are not always properly diagnosed, or informed about FDA approved usage guidelines, or about side effects and other safer alternatives that they may want to try first. Is that really the Texas attorney general’s concern?
It is hard to say for sure, but that very concern rests as part of the basis of an ongoing lawsuit brought by a consumer/patient in California superior court against her dermatologists. In that case, a dermatology company operated by dermatologists, Dr. Feilds and Dr. Rodan, has been sued by a woman who claims she has suffered “irreversible skin discoloration and permanent disfiguration to the skin on her face”, alleging it comes from the use of the Rodan & Field’s hydroquinone products manufactured under the “Reverse” brand. The suit also claims that she was never properly informed of the risks associated with hydroquinone, or that there are other safer alternatives commercially available, and that the defendant “knew or should have known” about these risks before recommending and supplying the product.
This case is ongoing, and so the merits and outcome are not yet known. However, one of the messages that can be taken to heart by dermatologists and other skincare physicians, is that a little precaution can go a long way. Giving their patients information about the potential risks and side effects associated with hydroquinone products, as well as providing them with options for treatment using some of the newer non-hydroquinone products and procedures now available, will increase patient satisfaction and strengthen the patient-doctor relationship.
Why use hydroquinone at all? In part, hydroquinone is used because it has history on its side. For 50 years or more, physicians have prescribed a hyroquinone product for the temporary treatment of melsama or other hyperpigmented issues of the skin (in other words, to help reduce patchy discolorations in the skin). For most of that time, its use was limited both in the number of patients treated and in the duration of time they
would use it. Over the last twenty years however, hydroquinone has found its way into marketed skincare brands that promote long term use. This has created a growing problem that has not gone unnoticed by some medical professionals. The Dr. Oz show featured a segment on this issue, with guest Eliot Battle, MD, a prominent dermatologist based in the Washington D.C. area.
Dr. Battle noted that the number one concern from patients in his offices is getting a clear complexion. Dr. Oz showed a case of a woman who suffered a permanent darkening, or “blueing” of the skin due to ochronosis, associated with hydroquinone use (or misuse). While he noted that under proper medical supervision hydroquinone can be quite beneficial, he also described the growing concern with wide-spread use of these products. Dr. Battle noted that in the past, he would see patients coming in to his practice with hydroquinone or topical steroid related skin damage about once a year.
“We are now seeing this monthly, or weekly, most of the patients are getting these drugs, these medications, from the internet or over-the-counter,” commented Dr. Battle. “This condition now has gotten to be so popular unfortunately, that we are nervous about this.”
Dr. Zein Obagi, who is the principle creator of the Obagi Nu-Derm system, has added his voice to the concern, recently going on record in confirming that most patients build a resistance to hydroquinone, such that the hyperpigmentation they were trying to treat not only comes back, but will no longer respond to even prescription levels of hydroquinone. When that happens, you have a real problem. In Dr. Obagi’s own words, he says “For example, where hydroquinone might have previously been used, it is now known that 80% of patients can develop a resistance if used for more than a few months.”
That is 8 out of every 10 people for those keeping score at home. Dr. Obagi and Dr. Battle’s comments raise a good question. As noted earlier, the world of cosmetic (non-prescription) products are limited to lower concentrations of HQ – and therefore there should be less concerns with blemish creams and skin lighteners found on those shelves right?
Apparently not. The Journal of Dermatologic Clinics report mentioned above notes that there have been 51 documented cases of exogenous ochronosis (a premanent bluish darkening of the skin) caused by hydroquinone use in the United States, “all in patients using low-concentration (less than 3%) hydroquinone for a short duration (less than 1 year).”
Adding to that documented risk, the Chicago Tribune reported on the shocking results of an investigation they conducted wherein they sent 50 skin-lightening creams to a certified lab for testing, most of them bought in Chicago stores and a few ordered online. Of those 50 products tested, six were found to contain amounts of mercury banned by federal law. Of those, five had more than 6,000 parts per million — which is enough to potentially cause kidney damage over time, according to one of the paper’s consulted medical experts. Proving it is not an issue unique to Chicago, earlier this year, similar discoveries were made by health officials in the state of California.
“I’m shocked and speechless,” said Dr. Jonith Breadon, a Chicago dermatologist contacted with the results by the Tribune, who said she sees patients weekly who ask about lightening their skin. “I just assumed since (mercury) was banned in the U.S., it never got in. But clearly that isn’t true.”
What is true, is that there are safe new technologies for addressing hyperpigmentation on the face and other parts of the body. One example is a new peptide technology discovered by Stanford University dermatology researchers, and developed under the trade name Lumixyl. A clinical study evaluating both the safety and efficacy of the Lumixyl Topical Brightening System was recently published in the April 2012 issue of the Journal of Cosmetic and Laser Therapy. That study on 15 women with moderate to severe photo-damage related hyperpigmentation showed significant improvement in all of the study participants. Earlier studies have documented that the peptide technology is completely non-toxic, and therefore safe to use in topical cosmetic formulations.
According to dermatologist Dr. David J. Goldberg (www.skinandlasers.com), one of the lead authors on the study: “Lumixyl is a novel, effective and well-tolerated topical skin lightening product that serves as a great alternative for those not wanting the irritant effect of most currently available skin lightening products.”
“It is particularly valuable for treating chronic or persistent hyperpigmentation conditions, where longer term use of prescription products are a concern. This study suggests that a decapeptide-12 based regimen can achieve excellent results, without the risk of side effects commonly associated with hydroquinone,” said Dr. Goldberg.
If you find yourself plagued by hyperpigmentation, blotchy uneven tone, or discolored patches due to years of sun exposure, there are two pieces of sage advice to be gleaned. First, be skeptical of lotions and potions making promises online or at the local store. The risks often outweigh the benefit. And second, be proactive in consulting with your doctor on the best way to achieve long term results that translate to healthy skin function. There are new alternatives, and where a prescription product is needed, there should be a timeframe discussed for getting the desired result, and close monitoring to ensure your skin is safely on track to a healthy positive outcome.
3) Skin whitening creams found to contain toxic mercury. Chicago Tribune