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Possible Hydroquinone Ban by FDA
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Margot
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Sun Sep 02, 2007 2:24 pm      Reply with quote
I've been hearing more and more about a possible ban in the US of all products containing hydroquinone (initially proposed in October of last year) due to possible liver damage, cancer risks, link to ochronosis...I'd be interested to know what other folks have heard regarding this and what they would plan to use to treat dark spots/discoloration - especially fellow Obagi fans! Since just about everything except broccoli has been linked to cancer, and the incidence of ochronosis is reportedly very low, I wonder if the dangers are being overstated and "assume" misuse by consumers, or if perhaps the caution is justified and I should resign myself to my former Dalmation-like complexion?
rileygirl
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Sun Sep 02, 2007 7:28 pm      Reply with quote
This was discussed in the thread "skin lightening/brightening products that are banned" so something similar. Do a search for hydroquinone and you can find the thread. HTH!
havana8
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Sun Sep 02, 2007 7:37 pm      Reply with quote
http://www.essentialdayspa.com/forum/viewthread.php?tid=25350&highlight=hydroquinone
Margot
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Sun Sep 02, 2007 7:37 pm      Reply with quote
Sort of...it doesn't discuss anything definitive about the FDA ban, but I guess that's available online at the FDA. I'm also suspecting people aren't interested in weighing in on the controversy. Should not have posted this.
vonstella
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Sun Sep 02, 2007 8:13 pm      Reply with quote
Margot wrote:
Sort of...it doesn't discuss anything definitive about the FDA ban, but I guess that's available online at the FDA. I'm also suspecting people aren't interested in weighing in on the controversy. Should not have posted this.


Its fine that you posted this! Im interested but dont have the time for research. Do let us know what you find!

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Sun Sep 02, 2007 9:06 pm      Reply with quote
Margot, I have not heard anything definitive on the fda and hydroquinone as of yet. The last thing I remember reading was that it would not be an all inclusive type of a deal, but one where they would evaluate an individual product and if there were any negative findings, then the company would have to reapply to the fda. Sorry, I did not read your post well, I thought you were just asking on opinions on the safety of HQ!
havana8
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Mon Sep 03, 2007 11:11 am      Reply with quote
Hydroquinone and the FDA—the debate?

Journal of Drugs in Dermatology, Feb, 2007 by Melanie D. Palm, Ella L. Toombs

Recently you may have received e-mails, telephone calls, letters, or read articles stating that within the next few months, hydroquinone--our workhorse bleaching cream--will be banned in the US. Point of clarification, on August 29, 2006 the US Food and Drug Administration (FDA) published a monograph in the United States Federal Register proposing that all hydroquinone products, which have not been approved through the New Drug Application process, will be considered misbranded and therefore banned. This "proposed rule" allowed anyone to submit comments to the FDA by a specified date (in this case December 27, 2006--later extended 30 days) before the "final rule" is published. Once the final rule is published in the Federal Register, manufacturers will have 30 days to remove noncompliant hydroquinone products from the marketplace or risk seizure, fines, and possibly imprisonment.

The following is the history behind the proposed ban. Prior to 1962, the year Congress passed the Kefauver Harris Amendment, drugs sold over the counter (OTC) were assumed to be not only safe but also effective. The congressional amendment granted the FDA the authority to review the entire OTC drug market--thousands of products. As a result of the review spanning over 40 years, hydroquinone was one of many products receiving the "GRASE" (generally recognized as safe and effective) designation. In the 1980s, reports of exogenous ochronosis secondary to hydroquinone use by South African Blacks appeared in the medical literature. A large proportion of these reports describe subjects that had applied high concentrations (6%-8.5%) of hydroquinone-containing products (hydroalcoholic solutions, some with mercury and/or resorcinol) over extensive body surfaces, several times a day, for years and even decades. The FDA met with US hydroquinone manufacturers; agreements were made to supply the FDA with studies supporting hydroquinone's safety. The FDA states it never received the data. In the interim, the FDA's National Toxicology Program (NTP) completed a pharmacologic-toxicology profile on hydroquinone. The results were reviewed by both the FDA and its Cancer Assessment Committee, and hydroquinone was classified as having "some evidence of carcinogenicity."

We have received a list of nongovernment-sponsored pharmacology/toxicology studies from the consumer health care industry that were not included in the FDA's proposed rule. They may not have been aware of their existence when the rule was written. It is important to understand that when these animal studies are performed large amounts of the drug product (far exceeding human dosages) are administered systemically and dermally in order to obtain worse case scenario information. To the best of our knowledge, their have been no cases of cancer associated with cutaneous application of hydroquinone.

The FDA states that due to the reports of "disfiguring ochronosis," toxicology risks, and lack of economic impact (the economic impact of banning hydroquinone to the manufacturers could not have been that great or they would have completed the safety studies) the rule is proposed.

We have reviewed all the exogenous ochronosis cases cited in the Federal Register document, along with the currently available English medical literature. It comes as no surprise that the use of hydroquinone by the American consumer is very different from that of their African counterparts in frequency, duration, amount applied, and concentration/formulation. We found less than 25 reported cases of hydroquinone-associated ochronosis in the US over the past 25 years. Certainly, there may be unreported cases; however, conservative use of the data suggests that there would be one case of exogenous ochronosis for every 300 to 450 million units of hydroquinone sold in the US. Nonpublished manufacturing data from the hydroquinone producers would decrease the incidence further. The clinical and histological descriptions of the large patient numbers in the African "series" demonstrate a much more aggressive disease than in the rare US cases. Furthermore, the exogenous ochronosis reported in US patients responded to treatment.

The pharmacology data is a concern; we would not want our patients or the American consumer to use drugs whose benefits are outweighed by the risks. The FDA's evaluation of the results was that there was "some evidence of carcinogenicity." "Some evidence" is not a strong enough indictment to necessitate banning a drug for which there are no acceptable, readily available, affordable, and safe alternatives for so many Americans.

On behalf of the Dermatology Section of the National Medical Association, we included in our response to the FDA a request that in consideration of their "mission" they: 1) consider the cases of exogenous ochronosis reported in the US--not Africa, 2) review all of the available pharmacology/toxicology data on hydroquinone, and 3) use their resources to obtain epidemiologic human data to fully answer the safety questions.

Melanie D. Palm MD
Ella L. Toombs MD
Department of Dermatology
Rush University Medical Center
Chicago, IL

COPYRIGHT 2007 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2007 Gale Group
Margot
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Mon Sep 03, 2007 12:38 pm      Reply with quote
First of all many thanks for the encouragement (I'm kind of "post shy") and havana8 for the update. The article does confirm what I suspected re use and frequency...at any rate, the FDA can take my Obagi, but they'd have to pry it out of my cold dead hands!
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