Roaccutane Side Effects: More Scandalous Goings On With Pharmaceutical Drugs

Here's how you know when a drug's side effects are completely out of control: When the government requires you to place your name and personal details about your sex life in a national registry in order to purchase the drug.

In this case it is the US government taking this kind of action, as this is a plan that a US Food and Drug Administration (FDA) advisory panel has come up with in an effort to reduce birth defects caused by Roaccutane (marketed as Accutane in the US) -- the prescription medicine designed to treat severe acne.

While this may seem like a very extreme situation in the US, it is in marked contrast to the UK where there is a total lack of action. And it's not because the side effects aren't widely known about in the UK. As well as the fact that the link between the drug and birth defects are known about in the UK, the drug has also been linked to causing emotional instability.

The UK Medical Control Agency (MCA) released figures back in February 2001 stating that since the introduction of the drug in 1982, 1,795 adverse reactions have been recorded on their database, of which 23 were fatal, 14 being actual suicides. More than 200 of the adverse reactions were psychiatric with 20 reports of suicidal thoughts or suicide attempts. There were 80 reports of depression and 13 reports of mood swings.

Other side effects (listed on the web site of Roche, Roaccutane's manufacturer) include depression, psychosis, acute pancreatitis, inflammatory bowel disease and vision and hearing impairment. And in 1990, the FDA estimated that since the drug's introduction in 1982, there had been 11,000 to 13,000 Roaccutane-related abortions, and 900 to 1,100 Roaccutane-related birth defects.

But for anyone, young or old, who copes with the discomfort and embarrassment of serious acne, the need for a drug and all its side effects might be made completely unnecessary with a simple change in diet.

...so what exactly is going on in the US?
All of the side effects listed above are troubling, and the suicides are particularly alarming. But last week's recommendations from the FDA advisory panel specifically address the tragic tendency of Roaccutane to cause severe birth defects when used by pregnant women.

In 2001, Roche began a programme to help prevent birth defects associated with the drug. Under this programme, all females who take Roaccutane are encouraged to use two forms of birth control and take regular pregnancy tests.

Even though these guidelines make it very clear that Roaccutane users who become pregnant are putting their unborn children in grave danger, the rate of birth defects stayed about the same.

In response, the FDA panel recommended that the guidelines become mandatory, and that a registry be established to list every Roaccutane user (male or female), along with a record of pregnancy tests and birth control use.

If the FDA decides to accept the panel's recommendations, Big Brother will be looking over the shoulders - and in the bedrooms - of all Roaccutane users.

Three strikes
To say the least, the FDA is a very aggressive regulatory agency in the US. But this plan for a registry that will record details about a patient's sexual life is an extreme invasion of privacy, even by FDA standards. I only hope that such measures are not enforced in the UK.

Furthermore, this plan is not even necessary because it simply won't work. Here are three reasons why:

1) The programme to prevent pregnancy among Roaccutane users is already in place. If users don't follow the current programme, they're not likely to follow it when it's mandatory, unless each female user is escorted everywhere she goes by an FDA Roaccutane policeman.

2) The regulations can't possibly be monitored and enforced. During a time in the US of budget cutbacks throughout government agencies, is the FDA really going to mount a Roaccutane Task Force to make sure all the pregnancy tests have been submitted and everyone is taking their birth control? And if not, what's the alternative? Will they start arresting Roaccutane users when they become pregnant?

3) If you go to the Internet and search 'Accutane or Roaccutane' and 'without a prescription,' you'll get scores of responses - site after site after site - offering the drug with no questions asked. Needless to say, these sites don't require pregnancy tests or any assurances about birth control.

Potato pushaway
According to a dermatologist who's also a member of the FDA advisory panel, one of the problems with Roaccutane is that it's over-prescribed. The drug is intended to address only very severe cases of acne that create large cysts. Inevitably, however, many doctors prescribe the drug for relatively normal acne cases.

This is a shame, because for people who don't have extremely aggressive acne, a change in diet will often help clear things up.

In a 2002 article published in the Archives of Dermatology, US researchers at Colorado State University wrote that acne is a problem for as much as 95% of adolescents, and half of the men and women over age 25 in westernised societies, while the rates are much lower in non-westernised countries. In fact, they call the difference in the rates 'astonishing.'

For many years, alternate medicine practitioners and nutritionists like Dr Jonathan V. Wright and Adelle Davis have known that wheat intake can prompt acne outbreaks. And recent studies confirm that acne thrives when the diet is rich in high glycemic foods. Here's the suspected chain of events: Bread, cereal or potatoes are consumed, digestion increases glucose levels, insulin production rises and triggers hormones to secrete sebum in pores of the skin, and the sebum attracts acne-promoting bacteria.

According to many dermatologists, a wide body of anecdotal evidence supports the theory that a low-carbohydrate diet may be the best first defence against acne for patients of all ages. If you know a young friend or family member who suffers from this painful and often embarrassing problem, let them know that there may be a safe dietary alternative to powerful drugs with dreadful side effects.

Same old same old
Once again I can't help but note that if a herbal supplement were associated with the level of problems that Roaccutane is, we would hear nothing but long howls of indignation that such a product is available to youngsters, let alone frequently prescribed to them.

And it would be followed by cries from the pharmaceutical industry and mainstream medicine demanding its immediate removal from the market, which would probably still be preferable to them monitoring the activity in your bedroom.