January 24, 2005 - 6:25pm
As a relative newcomer to pill identification, I have a perhaps naive question... A friend said that her accutane pill has a picture of a pregnant woman with a slash through it. Is this true? Are there rules about whether potential teratogens have to be specially marked?
-Lj
January 24, 2006 - 3:45am
#2
I know this post is a year
I know this post is a year old, and most of us have seen or read about the current restrictions placed on Accutane in the past year or so (every patient being entered into a "database", refill restrictions, etc)
Just wanted to add, that Accutane has indeed had a
picture of a pregnant woman with the "circle and slash" through it
and has for some time. I know it was on there at least 4 years ago when
I took this med. (If I remember correctly the photo was on the back of
every single cardboard "punch tab" that covered the foil through which
the pills are pushed in the monthly supply fold up packaging/fancy
blister pack). It has been shown to cause severe birth defects and most
doctors recommended/required their female patients to be placed on
birth control (I did not have this problem obviously, but my girlfriend
did when she took it). I believe now that birth control is required
across the board in female Accutane patients as part of the new series
of mandates, and a second form of contraceptive is strongly urged as
well.
Hi -Lj and welcome to Pharmer.org.
And no question is a naive question. Knowledge is power.
I'll try to answer both of your questions, but you will have to do more research with the links provided.
As far as I know, the Accutane pill does not have a picture of a pregnant woman with a slash through it. The most recent pictures of different strengths that I can find are dated 2002 and can be seen on Eckerd's Drug Advisor database:
http://www2.eckerd.com/content.asp?content=pharmacy%2Fdrugadvisor
And the imprints have not changed according to Roche's package insert:
http://www.rocheusa.com/products/accutane/pi.pdf
If you read the package insert .pdf file, you will see the picture you mentioned together with a black boxed warning not to be pregnant, become pregnant or breast feed while using Accutane.
At present I can't find any reference that teratogens have to be specially marked. Of course, the package insert will have a boxed warning similar to Accutane's warning. But it would certainly be a good idea to add a warning symbol on the pill as part of the imprint.
Accutane was approved about 20 years ago. Presently it's very restricted. The FDA, doctor and pharmacist all work together to ensure that Accutane is dispensed only after compliance with many safeguards.
For more information, here is a link to several FDA articles:
http://www.fda.gov/cder/drug/infopage/accutane/default.htm
If you have any other questions, please post again. And we'll do our best to find the information you need.