kat27
03-04-2001, 03:00 PM
These incidents have been reported to the FDA/Medwatch program for the reporting of adverse effects due to a drug. The drug is a prescription acne medication called, Accutane. Copies of the adverse event reports can be obtained under the Freedom of Information Act, IH-35.
Papilledema,headache,nausea,vomiting and visual disturbances are early warning signs of Psuedotumor cerebri. Vascular thrombotic disease,stroke,dizziness,drowsiness,head ache,insomnia,lethargy,malaise,nervousne ss, paresthesias, seizures,syncope,weakness, depression, psychosis, suicidal ideation, suicidal attempts,emotional instability are listed in the pharmaceutical insert dated May,2000.
Please read the revised/updated, May,2000 pharmaceutical insert on Accutane for more info. on possible side effects associated with the use of this drug. Also a Medguide has now been required by the FDA to be given out with this drug.
Papilledema,headache,nausea,vomiting and visual disturbances are early warning signs of Psuedotumor cerebri. Vascular thrombotic disease,stroke,dizziness,drowsiness,head ache,insomnia,lethargy,malaise,nervousne ss, paresthesias, seizures,syncope,weakness, depression, psychosis, suicidal ideation, suicidal attempts,emotional instability are listed in the pharmaceutical insert dated May,2000.
Please read the revised/updated, May,2000 pharmaceutical insert on Accutane for more info. on possible side effects associated with the use of this drug. Also a Medguide has now been required by the FDA to be given out with this drug.

