The FDA announced its plan designed to prevent pregnant women from taking the acne drug Accutane, which can cause serious fetal abnormalities. David Graham, an FDA scientist in the FDA's Office of Drug Safety, voiced his concerns over the lack of action being taken regarding warning pregnant women not to take Accutane.
The target date for the Accutane plan is July 2005. The proposed guidelines of the plan are as follows:
A medical director of the March of Dimes stated that nearly 2,000 pregnant women have taken the drug since it was first introduced to the market in 1982. The director also cited the drug's ability to generate high profits as one of the reasons for the years of foot-dragging regarding stricter guidelines for taking the drug.
Concerns over the FDA's approval of a generic version of the drug and the possibility of patients not realizing the generic was the same as Accutane were also raised.
USA Today November 25, 2004
Accutane is one of the five drugs that Dr. David Graham warned Congress about at an earlier Congressional meeting. I am glad to see that the FDA is now tightening up the rules for prescribing this potentially disastrous drug.
In addition to Accutane, it would be best to avoid most ALL medications, even over-the-counter ones, if there is any chance of pregnancy. No drug has been proven to be completely safe during pregnancy.
As I said in a past newsletter article when I reviewed the evidence that Accutane is also associated with depression and suicide:
Accutane is not the miracle cure-all for acne that it is promoted to be. It has a category X for pregnancy, which means that it causes birth defects in nearly 100 percent of pregnant women.
There is no reason to even take the risk with Accutane, as the key to eliminating acne is to stop drinking soft drinks and juice and start drinking plenty of pure water instead. It is also necessary to eliminate ALL sugar (even beyond the soft drinks and juice mentioned above) and refined grains. If you're wondering why I give these recommendations, it's because eating refined carbohydrates and sugar leads to a surge of insulin and an insulin-like growth factor called IGF-1 in your body. This can lead to an excess of male hormones, which cause pores in the skin to secrete sebum, a greasy substance that attracts acne-promoting bacteria. Additionally, IGF-1 causes skin cells known as keratinocytes to multiply, a process that is associated with acne.
This strategy works in the majority of people, but some do have naturally elevated testosterone levels, which can promote acne. In this case, non-synthetic vitamin A (the real McCoy -- my favorite is emulsified vitamin A from Biotics Research) is very helpful. It is likely not toxic in pregnancy, but nonetheless should be avoided to be absolutely safe.
To be effective one must use a high dose of 100,000-200,000 IU per day. The dose should not be used for longer than several months, as toxicity could be an issue if taken much longer.
It would also ideally be helpful to measure testosterone and estrogen levels. Typically it is the ratio between testosterone and estrogen that causes the acne. If there is too much testosterone relative to estrogen, acne will develop. So one of the other ways to treat acne would be to increase estrogen levels. One can do this with bioidentical hormones.
However, it is really important to understand that the first step in bioidentical hormone therapy is to get the diet right. If you are eating grains and sugars you will be nearly guaranteed to have abnormal hormone levels. So hormone therapy should only be a consideration after you have optimized your diet and failed to achieve the desired response.
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