Accutane – Accutane Side Effects

A division of Hoffmann-La Roche, Inc manufactures Accutane in the United States since 1982. It is used to cure chronic form of cystic acne. Roche Group is one of the leading company’s with its core business in diagnostics and pharmaceuticals. Hoffmann-La Roche is the drug unit of Roche Group.

Accutane is an effective medicine for curing severe recalcitrant nodular acne. Nodular can be described as lesions with more than 5mm of diameter. Over the period, these nodules may become hemorrhagic. Accutane contains Isotretinoin. People suffering from acne related embarrassment should be aware that Accutane has side effects.

Accutane has been associated with many hazardous side effects including following:

• Hearing and Vision Problems
• Central Nervous System Ailments
• Inflammatory Bowel Disease
• Depression and Suicidal Tendencies
• Liver Disease
• Pancreatic Damage
• Psychiatric Disease
• Birth Injuries and Birth Defects
• Bone and Muscle Damage

Like other prescribed drugs, side effects and complications of Accutane vary from case to case and patient to patient.  If a pregnant woman consumes Accutane, there is high possibility that she gives birth to deformed child. Consumption of Accutane may lead to spontaneous abortion and pre mature births.

It is not necessary that every adult or teenager taking Accutane develop depression or psychiatric problems. Measures have been taken to prevent the hazardous side effects of Accutane.Education has played a major role in preventing the side effects of  drugs fetal risk by educating pregnant women using these drugs.

Doctors and Healthcare professionals are provided with frequent updates on the side effects of the Accutane. Doctors are aware that accutane may cause depression, suicidal tendencies and psychosis. This information helps the doctors to make decisions based on the patients need and history. Doctors or healthcare professionals carefully monitor the patients consuming Accutane for the symptoms of Depression.

Accutane’s packaging guides patient for the signs of depression like loss of appetite, feeling of sadness, trouble in concentrating, suicidal thoughts, irritability and fatigue. Unfortunately, people consuming Accutane ignore these guidelines for clean and clear skin .

Due to the high risks and dangerous side effects of Accutane, FDA has made it mandatory for the Accutane users to sign a consent form. Pharmacists have to give warning brochure to the users called Medguide (Medication Guide). Mifeprex, Accutane and Thalidomide are three drugs that required Medguide in the history of United States.

iPLEDGE Program to Protect Accutane Consumers

Some of the most dangerous side effects of consuming Accutane are associated with birth defects and pregnant women. The Federal Drug Administration recommends that pregnant women, women who are breastfeeding or who are expecting to be pregnant should not consume Accutane. Because of the serious side effects, FDA continuously regulates the distribution and packaging of Accutane.

FDA conducted the Isotretinoin risk management program in 2004.  Program concluded that some major improvements and revisions are required in the distribution of Accutane. FDA introduced risk management program, iPLEDGE, in addition to the guidelines in the packaging and educational programs. Primary aim of this program is to prevent the consumption of Accutane during pregnancy.

Certain manufactures of Accutane have introduced a program requiring registration of doctors and patients to accept the responsibilities before using the drug. By the end of March 2006, healthcare professionals and doctors who have registered themselves at iPLEDGE program can only prescribe Accutane. Moreover, a patient who has signed the consent form and abided to follow the guidelines of iPLEDGE may be prescribes Accutane. Isotretinoin is available with only those pharmacies registered with iPLEDGE.

According to the iPLEDGE guidelines, before starting the consumption of Accutane, women have to undergo pregnancy tests, the results of which should be negative. In case of women who are breastfeeding, Accutane may be transferred to the baby. Every woman undergoes counseling before starting the course of Accutane.

FDA is under the process to approve the program under Administration’s regulation to impose restriction on the distribution of certain drugs to ensure safe use. This program is called 21 CFR 314, Subpart H.