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Revision of Accutane Prescribing Information (archive under Acne)

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Revision of Accutane Prescribing Information (archive under Acne)

Posted by
June on September 08, 2000 at 21:10:18:

As I answered yet another post about Accutane I noted some changes in Roche's prescribing information. There is even more emphasis on adverse events during pregnancy and they have at last added the plate closure risk which has been mentioned on this board before. There is more urgency in their warnings and more seriousness in their prescribing instructions than in the old information. Looking through the page I'm linking below I must say I was chilled. I certainly hope that practitioners, pharmacists and patients alike will more seriously consider the many possible health risks inherent in use of this drug.

June



Re: Accutane Prescribing Information - truely scarry stuff!

Posted by RocketHealer Jim++ on September 08, 2000 at 22:57:40:

In Reply to: Revision of Accutane Prescribing Information (archive under Acne) posted by June on September 08, 2000 at 21:10:18:

June:

Thanks for pointing out this major update.

I read thru this revised Complete Accutane Product Info and was impressed how much they added and emphasized sooooooooo much more strongly than before. I double-checked that the page you linked is the same page that is linked in our Glossary. The revision date is May 2000.

The only thing I thought they "left out" as it were was the "hair abnormalities". We've heard here from a lot of folks with "hair abnormalities", some of which were permanent. I thought they might have been more informative about that rather than just saying "hair abnormalities". That's easy to miss or to downplay.

On second thought, I don't remember seeing anything about drugs/alcohol, other than that drinking alcohol could affect the necessary periodic tests for blood lipids. We get sooooo many questions about that here. It would have been nice if that had been clearly updated too.

Scarry stuff indeed!
RHJ++



Re: Accutane Prescribing Information - truely scarry stuff! -- To June

Posted by KMD on September 09, 2000 at 10:29:52:

In Reply to: Re: Accutane Prescribing Information - truely scarry stuff! posted by RocketHealer Jim++ on September 08, 2000 at 22:57:40:

Hi June,

I just wanted to thank you for all you have been contributing to this board. Your replies are always so helpful! I just wanted to give you a pat on the back for all your hard work here lately.

Namaste'!



Re: Accutane Prescribing Information - hair abnormalities

Posted by
June on September 09, 2000 at 11:46:15:

In Reply to: Re: Accutane Prescribing Information - truely scarry stuff! posted by RocketHealer Jim++ on September 08, 2000 at 22:57:40:

Jim,

I guess their lawyers thought they could just get away with providing that disclosure instead of more details. Since Accutane is often taken by those who are distraught about their appearance, I guess Roche wanted to give as little info about the hair loss probability as they could; after all, trading a great head of hair for the **possibility** of clear skin would probably put some folks off.

June



Re: KMD, I really appreciate your note. (NMI)

Posted by
June on September 09, 2000 at 11:47:47:

In Reply to: Re: Accutane Prescribing Information - truely scarry stuff! -- To June posted by KMD on September 09, 2000 at 10:29:52:


nmi



Re: Revision of Accutane Prescribing Information (archive under Acne)

Posted by
kathy on September 09, 2000 at 13:29:01:

In Reply to: Revision of Accutane Prescribing Information (archive under Acne) posted by June on September 08, 2000 at 21:10:18:

Its too bad Roche did not put any warnings about cerebral accidents that are listed numerous times in the FDA MedWatch reports along with seizures and syncope.
If you want an eye-opening experience about Accutane then request the FDA reports on adverse events. Request the reports under the Freedom of Information Act-IH35.
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857

Ask them to waive the fee for this request.

I asked them for adverse effects from 1982 to the present time. I only received the last two years of reports--810 pages with 4 to 7 reports per page. It made me sick at heart to look at all the health problems/disabilities/death linked to Accutane use of our teens and young adults. Adults in their thirties and forties were listed too.



Re: Revision of Accutane Prescribing Information (archive under Acne)

Posted by
kathy on September 09, 2000 at 13:31:11:

In Reply to: Revision of Accutane Prescribing Information (archive under Acne) posted by June on September 08, 2000 at 21:10:18:

Its too bad Roche did not put any warnings about cerebral accidents that are listed numerous times in the FDA MedWatch reports along with seizures and syncope.
If you want an eye-opening experience about Accutane then request the FDA reports on adverse events. Request the reports under the Freedom of Information Act-IH35.
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857

Ask them to waive the fee for this request.

I asked them for adverse effects from 1982 to the present time. I only received the last two years of reports--810 pages with 4 to 7 reports per page. It made me sick at heart to look at all the health problems/disabilities/death linked to Accutane use of our teens and young adults. Adults in their thirties and forties were listed too.



Re: Revision of Accutane Prescribing Information (archive under Acne)

Posted by
kathy on September 09, 2000 at 13:32:00:

In Reply to: Revision of Accutane Prescribing Information (archive under Acne) posted by June on September 08, 2000 at 21:10:18:

Its too bad Roche did not put any warnings about cerebral accidents that are listed numerous times in the FDA MedWatch reports along with seizures and syncope.
If you want an eye-opening experience about Accutane then request the FDA reports on adverse events. Request the reports under the Freedom of Information Act-IH35.
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857

Ask them to waive the fee for this request.

I asked them for adverse effects from 1982 to the present time. I only received the last two years of reports--810 pages with 4 to 7 reports per page. It made me sick at heart to look at all the health problems/disabilities/death linked to Accutane use of our teens and young adults. Adults in their thirties and forties were listed too.



Re: Corrected link for RAGE site Roaccutane Action Group Enforcement

Posted by RocketHealer Jim++ on September 09, 2000 at 15:27:14:

In Reply to: Re: Revision of Accutane Prescribing Information (archive under Acne) posted by kathy on September 09, 2000 at 13:29:01:

Corrected link below for RAGE - Roaccutane Action Group Enforcement, Ireland

RHJ++



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