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Accutane Teratogenicity Program called inadequate. (Voluntary Provisions seen as Problematic).
MAUI, HAWAII -- SMART, the new teratogenicity management program for Accutane, does not go far enough because too many of the provisions are voluntary, Dr. Kenneth L. Jones said at the annual Hawaii dermatology seminar sponsored by the Skin Disease Education Foundation.
"I think there are many positive aspects to the SMART (System to Manage Accutane-Related Teratogenicity) program, but I think it has not gone far enough," said Dr. Jones, a professor of pediatrics at the University of California, San Diego, and a member of the Teratology Society, which has argued for greater restrictions on Accutane.
Many pregnancies continue to occur in women on Accutane, and many of these exposures are not reported, either to the Food and Drug Administration's MedWatch program or to the Slone Epidemiologic Survey maintained by the Boston University School of Public Health. These exposures need to be recorded in order to know how many there truly are because the results can be so devastating, he said.
Dr. Jones said that he sees many ...
- Next year, Accutane gets 'SMART'. (New Teratogenicity Program).(Brief Article)
- Magazine article from: Skin & Allergy News Mechcatie, Elizabeth December 1, 2001 700+ words
The new SMART program to prevent Accutane-exposed pregnancies...effective in January, SMART--or System to Manage Accutane-Related Teratogenicity...prescribing atmosphere for Accutane, Dr. Pariser urges...prescribers to follow SMART and to encourage...
- Accutane. (Drugs, Pregnancy, and Lactation).
- Magazine article from: OB GYN News Koren, Gideon January 1, 2002 700+ words
...manufacturer, to do more to prevent Accutane-exposed pregnancies and strengthen...Pregnancy Prevention Program for Women on Accutane. The System to Manage Accutane-Related Teratogenicity (SMART) will have some impact in reducing exposed...
- Companies warned about unapproved accutane.(Updates)
- Magazine article from: FDA Consumer November 1, 2003 700+ words
...distribution program known as the System to Manage Accutane Related Teratogenicity (SMART) program. The term "teratogenicity" refers...only certain physicians may legally prescribe Accutane. In addition, the prescription must be filled...
- FDA issues warning letter to Internet companies selling Accutane.
- Newspaper article from: Biotech Week October 1, 2003 700+ words
...which purports to be equivalent to Accutane, without requiring a prescription. Accutane is a drug that can cause birth defects...program known as the System to Manage Accutane Related Teratogenicity (SMART) program. The FDA action "illustrates...
- FDA issues warning letters to Internet companies selling unapproved version of...
- Newspaper article from: Warning Letter Bulletin September 22, 2003 700+ words
...to the skin) gel version of Accutane, which is sold only with foreign...According to the agency, Accutane is a drug that can cause birth...known as the System to Manage Accutane Related Terato-genicity (SMART) program. "Today's strong...
- Accutane pregnancy prevention rules revised. (Negative Pregnancy Test...
- Magazine article from: OB GYN News Mechcatie, Elizabeth January 1, 2002 700+ words
...management program to prevent Accutane-exposed pregnancies...effective this month, SMART (System to Manage Accutane-Related Teratogenicity...ARTICLE: Highlights of SMART * Guide to best practices...booklet, which covers Accutane facts, the revised...
- Program Is Revised For Accutane Patients. (Pregnancy Prevention).(Brief Article)
- Magazine article from: Family Practice News Mechcatie, Elizabeth December 15, 2001 700+ words
...aimed at preventing Accutane-exposed pregnancies...effective in January, SMART (System to Manage Accutane-Related Teratogenicity...ARTICLE Highlights of SMART * Guide to best practices...booklet, which covers Accutane facts, the revised...
- Tightened pregnancy prevention for Accutane Rx. (Qualification Stickers...
- Magazine article from: Pediatric News Mechcatie, Elizabeth December 1, 2001 700+ words
...program, dubbed SMART (System to Manage Accutane-Related Teratogenicity...there were 2,109 Accutane-exposed pregnancies...and Roche. The SMART program was developed...the highlights of SMART: * Guide to best...which covers Accutane facts, the revised...
