Is There Cause For Concern?
Let's be very clear about the history of this drug which is a form of vitamin A also sold under the generic name isotretinoin. It's been on the market for some 27 years. During this time, it has built up an unbeatable record for the treatment of acne. Usually taken for between three and six months, it produces lasting improvements in 99% of all patients and a complete cure for about 70%. To be absolutely clear about this record, this is not a snapshot from a single limited period of time. This is the average performance over 27 years. For the unlucky 30% who are not cured, a second period of treatment is almost always completely effective. What is this drug used to treat? Acne! This is the most devastating of cosmetic conditions imaginable. Although it's not officially an illness or disease, it's one of the most consistent causes of psychological damage in teens and young adults. No matter how parents, schools and authority figures might try to fight the bullying that often traumatises people at an early stage in their emotional development, the abuse continues unchecked. In many senses, it would be a disaster if anything was to affect the availability of this drug which is just about the only way in which people can survive the rite of passage.
Looking back over the last 27 years, there have been problems. The drug has been associated with an increase in the severity of depression, but the evidence is not clear cut. As you can imagine, the onset of acne is a routine cause of depression. Taking this drug at this time provides a link but it's by no means certain that the drug aggravates the depression. It's one of these coincidences awaiting clear proof one way or the other. However, there is no doubt that, if taken during pregnancy, it damages the unborn child. Instead of withdrawing the drug from the market, the FDA introduced the iPledge program which makes it condition of access to the drug that fertile women take two different measures to prevent conception. Put another way, even though many Christians object to the notion of contraception, preferring to promote abstinence, this program has become the norm for all young women who have acne. Everyone bends to keep this drug on the market and available for all to use.
New research was presented at the annual meeting of the American College of Gastroenterology in San Diego suggesting the possibility of a link between accutane and inflammatory bowel disease. This is a painful condition where the intestines swell and cramp causing diarrhea and loss of weight. People taking accutane are 1.7 times more likely to have this problem. But only seven people in 100,000 are diagnosed with this disease each year. So let's not get carried away with fear. This is a tiny increase in the risk to 0.007% of the population. If the FDA can keep this drug on the market given the real and consistent risk of damaging unborn children, there should be no reason for it to react to this news by withdrawing the license for the drug on the US market.
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