Questions about Accutane

Questions and Answers about
Accutane^® (isotretinoin, Roaccutane^®, Roaccutan^®)
According to an FDA import alert document, isotretinoin is marketed in other countries under the following names: Isotrex, Accure, Amnesteem, Antibiotrex, Isohexal, Isotrex Eritromicina, Isotrexin, Nimegen, and Oratane.

A message to the Roche Pharmaceutical Company, makers of Accutane (Roaccutane):

On your Australian web site, you say that "There is a great deal of inaccurate and misleading information about medications on the Internet written by people without medical/healthcare training." While that is true, I believe that you are trying to undermine the credibility of the many people who criticize your product. First, consider how Accutane has probably received more bad publicity than a hundred other drugs chosen at random from the PDR. Is this just a coincidence? I don't think so. By the way, how might you undermine my credibility? I graduated in the top 1% of my class in medical school, the director of my residency program once commented that I was the smartest resident they ever had, and one of my former bosses told me that I was the smartest doctor he ever met. Therefore, I've had the medical/healthcare training that you deem to be essential, and Accutane is the only drug I would never prescribe because it is too likely to induce regrettable effects, including some that are long-lasting or permanent. In my opinion, your intransigent defense of Accutane is undermining your credibility. You have other laudable drugs, but when you turn a blind eye to some of the side effects of Accutane, you naturally make physicians and the public skeptical of your trustworthiness.

Accutane causing vaginal pain and fragility

Q: When I took my second course of Accutane I developed severe vaginal pain during intercourse. For two days following intercourse, my vaginal lining would slough and during this period of time it was extremely sore. No tampons could be inserted and certainly no penises either! I saw several doctors through Kaiser Permanente, but none knew why it happened. Not one of them linked it to Accutane. It became almost impossible for me to have sex. I could still do it for a minute or two with a bearable amount of pain, but that too became rare. It has gotten to where I cannot have intercourse at all as insertion of anything feels like I am being stuffed with an extra large sandpaper dildo. Of course, this reduced my appetite for sex. I was a beautiful, flirtatious young lady with a steady boyfriend when this happened to me and suddenly my hopes for a healthy sex life or even a marriage were more or less destroyed.

Have you read about the researcher who worked for Roche who claims that Roche ordered him to destroy research documents on Accutane? I may have a copy of his story if you're interested. Niki

A: Yes, I am very interested, and I'd greatly appreciate that.

I think I will be able to help you overcome your problem, or at least minimize it. First, some background information. Accutane is known to cause skin fragility and dryness. It can also cause dryness of the mouth, lips, eyes, and nose. It can cause peeling of the palms and soles. It can induce eyelid inflammation and conjunctivitis, which is inflammation of the conjunctiva (the mucous membrane lining of the inner surface of the eyelid and the exposed whitish surface of the eyeball). It increases the probability of epistaxis (nosebleed). It can trigger keratitis (inflammation of the cornea). It can cause inflammatory bowel disease. It can also cause bleeding and inflammation of the gums (an interesting aside that is tangentially related to Accutane: researchers discovered that gums undergo cyclic hormonal changes during the menstrual cycle, which led them to theorize that oral tissues, like the vagina, possess hormone receptors). Considering the foregoing, I am not surprised when I've heard women report problems similar to yours. Accutane causes many problems other than the ones listed above, but one of its characteristic effects is to cause abnormalities with skin and mucous membranes (a.k.a., mucosa). The vaginal mucosa is not an exception, as you know.

In the Physicians' Desk Reference, Roche admits that the "exact mechanism of action of Accutane is unknown." Hence, it is not surprising that they do not understand the causation of Accutane's side effects. I think some of Accutane's effects result from it interfering with the action of certain hormones. This plausibly explains why Accutane can decimate libido and sexual pleasure, and why it can lead to vaginal problems such as yours (fragility and pain) that are typically seen only in hormonally deficient postmenopausal women (although your vaginal fragility is clearly worse). Hence, one logical therapeutic option is to use supplementary hormones. The mechanisms by which hormones act are very complex. Many doctors oversimplify this subject and think, or act, as if hormone levels were the only important key. In reality, they are just one link in the chain that begins with the body trying to do something and ends with the body accomplishing that task. Hormonal effects can be blocked by competitive inhibition (which I explain in The Science of Sex), various nutritional deficiencies, genetic problems, and exposure to certain chemicals — including Accutane, in my opinion.

I will give you an analogy to help illustrate why measuring hormone levels will not necessarily ensure that your hormonal effects are OK. To clarify this, I'll put the analogy equivalents in parentheses. Let's say that someone (a patient) has difficulty hearing sound (achieving a hormonal effect) from his AM radio (body). He consults an engineer (doctor), who uses a signal strength meter (a lab test) to determine the strength of the radio waves (the hormone level) in that area (in that patient). If you're knowledgeable about electronics, you know that the engineer could not possibly declare that everything was OK just because the signal strength was fine. Perhaps the radio receiver (the hormone receptor) was defective or blocked. Do you see what I'm getting at? Hormones do nothing by themselves. They're just messengers the body uses to signal desired effects. Just because the signal is OK does not mean the effect is OK. Inexplicably and perversely, many physicians ignore this fact. Whenever they wish to gauge action of a hormone, they do a lab test to measure its level. If engineers were that illogical, they would measure AM radio sound levels by testing radio wave signal strength. If you found an engineer that daffy, you'd fire him and find someone else.

I am not opposed to measuring hormone levels, but it is important to remember that hormone levels are just one link in the chain, so to speak. It is also important to assess the hormonal effects. If I were your doctor, I would evaluate the adequacy of your hormonal effects by looking at the hormonally responsive tissues of the body. Some of this investigation would involve visual clinical judgments, while other facets of the evaluation would involve biometric assessments and microscopic evaluations of hormone-responsive tissues (such as vaginal cells). I'd also use various clues (e.g., old photos and your self-assessments, pre- and post-Accutane) to help determine if Accutane is indeed blocking some of your hormonal effects. I'd then consider the totality of the evidence from your history, physical, and lab tests to assess whether or not your body's hormonal messages are "getting through," so to speak. I would not tell you that everything was hunky-dory just because your hormone levels were OK. If your hormonal effect deficits were confined to your vagina, you and I would consider using a topical vaginal cream to supplement the local hormonal effects. If your problems were more widespread, we might opt for oral or transdermal hormonal supplements.

But what if hormonal effects were not the root cause of your problem? Some of Accutane's adverse effects have no clear-cut connection with hormones. If that were true in your case, I'd offer you an invention I conceived while reading your question. This would enable you to experience pleasure with intercourse, instead of pain, and it would also be pleasurable for your partner. I assume that simple measures, such as sexual lubricants, were not adequately helpful.

If you want to read my book The Science of Sex, let me know and I will give you a free e-book copy of it. In any event, let's keep in touch and solve your problem.

More information on the sexual effects of Accutane^® (isotretinoin), a.k.a., Roaccutane^®

Accutane^® (isotretinoin) can permanently affect your sex life, reducing libido and sexual sensation. In some cases it may also induce sexual dysesthesias in which sexual sensations feel like "pins and needles" instead of being normally pleasant. If you or someone you know has been affected by any of these problems, please continue reading.

While there are many drugs that interfere with one or more aspects of sexuality while the user is taking them, with one exception all of these problems resolve once the drug is discontinued. The only drug that can permanently affect libido and sexual pleasure in some people is Accutane^® (isotretinoin), used in the treatment of severe recalcitrant nodular acne. Roche Laboratories, the manufacturer of Accutane, claims to be unaware of any such adverse effects. However, I have firsthand knowledge that their ignorance of this matter is, well, fishy. I called Roche in January of 1991 to discuss this problem which had been reported by a patient. Perhaps not surprisingly, they claimed to have never heard of any link between Accutane and long-term sexual dysfunction. When I called again in March of 1999 I was told the same thing, which caused me to question their credibility. They’d never heard of it? Bull. I’ve heard of several cases, and I’m not exactly the clearinghouse for the adverse effects of Accutane. Roche states that the "exact mechanism of action of Accutane is unknown." Well, if they don’t even know how it suppresses acne, perhaps they are equally unaware of how it affects the body in other ways.

The case that I presented to Roche in 1991 was one that should have caused them to seriously consider that Accutane’s sexual effects were a cause for concern. In this case, the patient took several courses of Accutane over a period of years. With each course of treatment the patient experienced reduced libido and altered sexual sensation. Instead of being pleasant, his sexual sensation was markedly unpleasant and felt similar to the sensation that people perceive when they strike their "funny bone" (ulnar nerve at the elbow). These symptoms would decrease somewhat when the patient stopped taking Accutane, but they never totally resolved. The patient concluded that the problems would abate entirely once he had been off Accutane for a longer time. The patient took additional courses of Accutane over the following years to control his acne, each time experiencing an exacerbation of the symptoms while on the Accutane and a reduction in the symptoms after discontinuing Accutane. After the final course of Accutane, the patient was alarmed that the symptoms persisted for more than a decade.

Whenever a scientist is presented with a case in which reintroduction of a drug induces problems that had abated once the drug was discontinued, and this concordance between symptoms and drug use continues over a number of cycles, it is virtually impossible to conclude that there is no connection between the drug and the problem. Therefore, Roche should not have dismissed or ignored the case I reported to them. Frankly, when Roche claimed in March of 1999 that they'd never heard of such a case, they were lying: I know they HAD heard about such a case before, because I told them of such a case in 1991. One might excuse this error as simple human forgetfulness, but this is a multi-billion-dollar corporation entrusted with our health and well-being. I find it difficult to believe that they cannot afford (or have the common sense to use) a simple computer database program that would keep track of all such adverse drug reactions, thereby obviating the need for their employees to remember such facts on their own. Since they have an obvious incentive for ignoring adverse reports, I don't think I'm being overly cynical by suggesting that their failure to properly use a database is behavior more befitting an ostrich ("Problem? What problem? I don't see any problem.") rather than a circumspect pharmaceutical manufacturer.

While I have heard of hundreds of cases linking Accutane to long-term sexual dysfunction (and other problems), I am certain there are many cases that have not yet come to my attention. Besides me, there are millions of other doctors in the world who may have fielded similar reports from their patients. Furthermore, I think that many people just suffer in silence if they have a sexual problem since it can be very difficult to discuss your sex life with someone even if he is a physician. The patient discussed above waited eight years before he mustered the courage to discuss his problem, and he’s probably not the only one who is reluctant to discuss sexual dysfunction.

I’d like to hear from you if you have experienced any sexual problems related to the use of Accutane. I will present a comprehensive report to Roche, and I will keep you updated on the search to find a solution to this problem. Additional information on this topic will be posted on my web site. In The Science of Sex, I discuss several ways to combat Accutane-induced sexual dysfunction.

You can contact me by clicking this hyperlink: www.MySpamSponge.com/send.php?handle=md

MySpamSponge is a site I developed that anyone can use to block all of their spam, but never any legitimate messages. With MySpamSponge, you communicate using handles instead of e-mail addresses. A handle is essentially a contact code that gives people a way to contact you via e-mail without you having to reveal your e-mail address. Similarly, you can send a message by using the recipient’s handle as the address (mine is MD).

Retin-A is tretinoin (a.k.a., all-trans-retinoic acid), and Accutane is isotretinoin (a.k.a., 13-cis-retinoic acid). Renova, another tretinoin skin cream, is intended to reduce fine skin wrinkling in older people, while Retin-A is used in treating acne. Percutaneous (through the skin) absorption of tretinoin is about 1%, and 13-cis-retinoic acid is one of the metabolites of tretinoin — that is, tretinoin breaks down into 13-cis-retinoic acid. According to its manufacturer, blood plasma levels of 13-cis-retinoic acid generally range between 1 to 3 ng/ml in patients treated with Retin-A. This is substantially lower than the plasma concentrations of 13-cis-retinoic acid seen in patients receiving Accutane. Patients receiving 80 mg of Accutane per day typically have a blood isotretinoin concentration of about 160 ng/ml. In my experience, patients treated with such high doses of Accutane can develop sexual side effects, but so can patients treated with much lower doses (e.g., 10 mg per day). I don't know if sexual side effects can develop from even lower levels of isotretinoin, but it may be prudent to avoid any source of 13-cis-retinoic acid since so many other treatment options are available for acne and wrinkles.

Q: Hi, I am a 24-year-old Norwegian girl who is suffering from severe acne, so I'm considering undergoing a third treatment with Roaccutane (called Accutane in the United States). The side effects are holding me back, but not for long, since I must get rid of my acne now. My chest and breasts are covered with acne. I cannot have sex with my new boyfriend, as I cannot undress and show my horrible appearance. I used to look OK, just the last 6 months have left me worse. So, should I have bad sex from side effects or not have sex at all?

You asked for your readers to tell you if they experienced sexual dysfunction after using isotretinoin. I didn't consider this possibility until yesterday, but my low libido might be attributable to two previous Roaccutane treatments. My first treatment was at the age of 13 or 14, then I had one at the age of 17. I have not had sex with more than one guy, for personal reasons, but I dated him for about two years. I find that my libido has been drastically reduced, and I also find that I don't get wet very easily. When I had sex, I felt all dried out after a few minutes. I would just want him to come to get it over with.

If you can help me with my acne or libido problems, please let me know. Best regards, Mari

A: Roaccutane (called Accutane in the US) can contribute to impotence, so it is not surprising that it can also contribute to impaired vaginal lubrication in women since that is the physiological analogue of male erection.

I have many acne tips in Fascinating Health Secrets, and I'll send a free copy of that to you once I convert it into an e-book. In the meantime, I'll send you some acne tips via e-mail.

In The Science of Sex, I discuss numerous ways of increasing libido — both in general, and also specifically in regard to depressed libido secondary to Accutane/Roaccutane.

Now on to your reluctance to have sex because you're embarrassed about your appearance. I know exactly how you feel, because I once had very bad acne, too. One thing I finally realized in regard to acne is that I was always FAR more concerned about my acne than I was about pimples on my girlfriend. Even if I noticed them and they consciously registered in my mind (believe me, there are far more interesting and important things to focus on), I'd think, "No big deal." Of course, I'd still worry about how she perceived my acne. I think most people are this way: we're far more forgiving of flaws in others than we are flaws in ourselves. Trust me, if your boyfriend did not think that you are beautiful and desirable, he wouldn't be with you. He wants you, and he won't be dissuaded by acne. No one is perfect. When I was an ER doctor, I took care of some celebrities, and they have flaws, too — but you might not see them if their clothes were on. Imperfection is just part of being human, so don't beat yourself up because you aren't perfect. Doctor's orders! :-)

You know that writer's block you get when you sit down to write the essay portion of your personal profile for online dating? And you know the difficulty you have trying to think of a catchy headline? Well, MyProfileWriter allows you to create a profile essay and headline without typing, just by clicking!