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Stricter Accutane guidelines will finally go into effect at the year's end

- October 3, 2005

Nearly 17 million people have acne, according to the National Institutes of Health. Various factors can affect acne, including stress, hormonal changes, greasy skin products, some medications and genetics.

For people with severe acne, the breakouts can be a cause of a great amount of anxiety, even affecting their social lives. While there are many over-the-counter medications that claim to fight acne, sometimes these products are not enough.

Acne that becomes deep, inflamed cysts can be painful and result in permanent scarring. For this severe form of acne, doctors will sometimes recommend a strong, controversial retinoid called Accutane.

Intended as a last resort, the derivative of vitamin A has been opposed to by some groups and doctors who feel the drug's risks were not adequately communicated, resulting in a high number of serious effects occurring for years before more rigorous guidelines were put into place. Accutane works by decreasing the size of the sebaceous glands, reducing the output of sebum and slowing bacteria growth.

The powerful acne medication has a high success rate, but it has also had a high adverse effect rate associated to its use. Known to cause miscarriages and severe birth defects, Accutane also carries risks of damage to the eyes, stomach, liver, intestines and other organs. Reports of suicide and suicide attempts have also been made among Accutane users.

For years, Accutane's maker and the FDA were criticized for failing to implement an effective pregnancy monitoring system for female patients taking Accutane. Nearly 2,000 pregnancies have occurred among Accutane users since it was first introduced in 1982, according to the FDA, and the majority of the pregnancies ended in abortion.

After several failed programs to curb Accutane pregnancies, the FDA has instituted new restrictions. Beginning this Dec. 31 st , all male and female Accutane users must enroll in a national registry called iPLEDGE or they will not be able to receive the drug.

IPLEDGE involves the entire Accutane dispensing process, including wholesalers distributing the drug, doctors prescribing the drug, pharmacies dispensing the drug and the patients using the drug. Female patients are required to submit two negative pregnancy tests before being prescribed Accutane, and after, they are required to use two forms of birth control while taking Accutane. Before receiving their monthly refills, all female patients must submit negative pregnancy tests.

For years, Accutane, despite being approved as a last resort treatment, was prescribed for patients with just mild or moderate acne. Because of the serious side effects associated to the drug's use, the widespread use was criticized, especially in the absence of proper preventative pregnancy guidelines.

For more information on Accutane side effects, including birth defects, please contact us .

 


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