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US FDA Advisory Committee Meetings Held to Discuss Isotretinoin, Safety Issues and a New Accutane Formulation
Stuart Maddin, MD, FRCPC
There is no drug that has provided as much therapeutic benefit for
12 million acne patients as this retinoid has done in the past 18
years following its introduction. However, it is a retinoid and,
therefore, a teratogen. In spite of the elaborate pregnancy
prevention program put in place by Hoffman-LaRoche, as well as
a tracking program monitored by the Slone Epidemiology Unit in
Boston Massachusetts, there are patients taking isotretinoin who
still get pregnant. More recently, adverse psychiatric events have
surfaced in patients who have taken isotretinoin (Accutane).
On the first day of meetings, risk management options to prevent pregnancy in patients taking Accutane were explored by the Committee. Discussions included Roche’s revised US Pregnancy Prevention Program (Targeted PPP or T-PPP). The Committee recommended that a risk management program for pregnancy prevention should consist of Roche’s T-PPP, a mandatory physician and patient enrollment, as well as establishing a linkage between the pharmacy that dispenses an Accutane prescription and confirmation of negative pregnancy test results for the patient.
The second day of meetings focused on risk management options
for psychiatric events and Accutane NF, Roche’s new
By the end of the meetings, the Dermatologic and Ophthalmic Drug/Pharmaceutical Science Advisory Committees supported the new formulation (Accutane NF). The Committee agreeed that there was at present no causal link between psychiatric events and Accutane. In spite of this, they recommended additional research with regard to possible psychiatric connections to Accutane, as well as the establishment of a registry to track women who are in their childbearing years taking Accutane. Challenges await Hoffman-LaRoche and the US FDA in establishing such a registry. It will be interesting to follow their progress.
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Last modified: Wednesday, 06-Aug-2014 12:41:24 MDT