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Isotretinoin (marketed as Accutane) Information

Isotretinoin (marketed as Accutane) Capsule Information

FDA Warning: Don't Buy Accutane Over the Internet

 

IPLEDGE Update (10/2007): FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See IPLEDGE Update

FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 8/12/2005 Labeling revision]

This information reflects FDA?s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Other Information

Historical Information

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FDA Warning:
Risks of Buying Accutane (isotretinoin) over the Internet

Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist. If you are pregnant or may get pregnant, isotretinoin can cause birth defects, miscarriage, premature births, and death in babies. Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects. Patients taking isotretinoin may experience side effects including bad headaches, blurred vision, dizziness, nausea, vomiting, seizures, stroke, diarrhea, and muscle weakness. Additionally, serious mental health problems, such as depression and suicide, have been reported with isotretinoin use.

  • You should NEVER buy Accutane (isotretinoin) or any of the generic versions of Accutane without first seeing your healthcare professional.

  • You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or could accidentally become pregnant.

  • Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.

To learn more about FDA's program to warn consumers against buying accutane and its generic versions online, please see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01595.html

To learn more about buying drugs safely, please see 


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