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Isotretinoin
(marketed as Accutane) Capsule Information
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.
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.
Back
to the Accutane main page
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