Severe Recalcitrant Nodular Acne

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Stronger Risk Management Program for Accutane (isotretinoin)


Accutane and Associated Risks

Often enough an indivudal hereditarily inherits acne or develops acne as hormones in the body begin to change. For many who suffer from acne, not only do they suffer from the pain externally but internally a positive self-image can begin to crumble. Since 1982 the Roche Group's prescription drug unit, Hoffmann-La Roche Inc., has been manufacturing an oral medication known as Accutane to citizens within the U.S.

For individuals who have unsuccessfully tried several methods including antibiotics to treat severe recalcitrant nodular acne, Accutane is usually then considered, as it is a highly effective oral medication treatment. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. According to definitions of the number of nodules an individual has to qualify him or her as having severe type of acne, the nodules range in the many category rather than those with mild acne having only few or several nodules.

Accutane, and its generics, contain Isotretinoin. While Accutane helps to cure severe acne sufferers, it does not go without several serious side effects that should be taken into account prior to beginning treatment.

Health complications and the legal issues surrounding those caused by Accutane involve the use by pregnant women and associated birth defects and the use by teenagers and associated depression and suicidal behavior. According to the Food and Drug Administration (FDA), women who are pregnant or who might become pregnant and women who are breastfeeding SHOULD NOT take the drug.

Since Accutane's release, it has been associated with numerous sever side effects such as:

* Birth Injuries and Birth Defects

* Depression and Suicidal Tendencies

* Psychiatric Diseases

* Central Nervous System Ailments

* Liver Disease

* Inflammatory Bowel Disease

* Hearing and Vision Problems

* Bone and Muscle Damage

* Pancreatic Damage

As with most prescription drugs, the side effects and severity of complications associated with Accutane vary from patient to patient and from case to case. Not every fetus exposed to Accutane has resulted in a deformed child, however, there is an extremely high risk that a deformed infant may result if pregnancy occurs and the woman has/had been taking Accutane even for very short periods. In addition, there is an increased risk of spontaneous abortion, and there have been reports of premature births associated with the use of Accutane. There have also been reported cases of IQs lower than 85 in some infants.

Similarly, not every teenager or young adult who takes Accutane will experience depression or suicidal thoughts. However, the potential for these side effects has caused enough concern, and are serious enough, that the risks must be addressed and taken very seriously.

Steps have been taken to help prevent Accutane's potentially dangerous and undesirable side effects. Since the introduction of Accutane, education has played a large part in reducing and preventing the drugs' fetal risks by reinforcing the importance of pregnancy prevention by women using the drug.

Prevention has not stopped at educating patients. Frequent updates and information on potential side effects of the drug are provided to doctors and other health care professionals. This includes notification to doctors that Accutane may cause depression and/or psychosis, as well as suicide, in some cases. This is to help ensure that health care providers make educated and ethical decisions based on the patients' history and personal needs. Doctors have also been advised to monitor patients very closely for symptoms of depression.

All prescription drugs come with educational material included in the packaging. Accutane's packaging advises patients to watch for signs of depression, such as feelings of sadness, irritability, fatigue, loss of appetite, trouble concentrating, thoughts of hurting oneself or suicidal thoughts. However, it seems the idea of regaining confidence with clearer skin often shields the severity of Accutane side effects.

Due to the number of potential complications associated with Accutane and the severity of the side effects, the FDA now requires any potential user to sign a consent form. Additionally, pharmacists must give users a detailed warning brochure from the FDA called a Medguide (Medication Guide). Only three drugs in United States history have been required the use of a Medguide: Accutane, Thalidomide and Mifeprex.

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