Re: Acutane/ OCD

[Guest guest]

Thanks

[Guest guest]

Thanks

[Guest guest]

Sheila,

My son took Accutane when he was 15 , He was a honor student, happy,

athletic, and had never missed a day of school or been sick.At 16 he had a

total

mental breakdown with a sudden onset of OCD and depression. He had to drop out

of school and was severely psychotic-. . There are over 66 cases of suicide

and over 1300 cases of psychiatric problems associated with the use of

Accutane have been reported to the FDA. Roche Pharm. was served with a $70

million

lawsuit claiming the medicine caused severe psychosis. My son is still

suffering at 22 and I have no other explanation for his collapse.

I'm going to see an attorney. What a nightmare. I'm happy for you that your

son is doing well.

My son also obsessed about religion and is now taking Lexapro .

Thanks for sharing,

Dana

[Guest guest]

This isn't related to OCD but thought I'd post it since it's on

Accutane:

Nov. 23, 2004 -- The FDA is strengthening its restrictions on the

acne drug Accutane and its generic equivalents in an effort to reduce

the risks of fetal exposure and birth defects associated with use of

the drug by pregnant women.

The move is in response to the recommendations of an FDA advisory

board earlier this year that urged tighter controls on the drug,

which is known generically as isotretinoin.

In February, advisory board members said better monitoring is needed

to track women of childbearing age to prevent them from becoming

pregnant while taking the drug.

The drug was also in the news recently after a group of lawmakers

called for a ban of the drug last month, and an FDA scientist named

it as one of five potentially dangerous drugs on the market in

congressional testimony last week.

Isotretinoin is used to treat severe acne that has not responded to

other treatments. Prescribing information and the drug's label warn

against use of the drug in pregnant women.

Under the new restrictions, manufacturers of Accutane and its generic

versions will be required to keep track of not only doctors who

prescribe the drug, but also the pharmacies that dispense the drug

and the patients who use it.

In addition to registering in a central database, the regulations

require verification of the following before a patient's first

prescription is filled:

Completion of patient education on the potential risks of the drug by

the prescribing doctor

Proof of a recent negative pregnancy test before dispensing the drug

Completed informed consent, education, and risk management

information by the patient

For subsequent refills, verification of monthly patient education,

repeat negative pregnancy tests, and ongoing risk management will

also be required.

The new risk minimization action plan (RiskMAP) for Accutane

(isotretinoin) and its generic equivalents calls for the drug's

manufacturers to:

Establish and maintain the database

Monitor sales of the drug outside the approved channels, such as on

the Internet

Develop procedures to monitor and evaluate RiskMAP compliance

Evaluate the effectiveness of the program in reducing exposure to the

drug during pregnancy

----------------------------------------------------------------------

----------

SOURCES: FDA. WebMD Medical News: " Lawmakers Call for Accutane Ban. "

WebMD Medical News: " Drug Safety at the FDA Under Fire: What to Do? "