Food and Drug Administration's Dermatologic Drugs Advisory Committee
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane, and is sometimes referred to by its former brand name, Accutane. Isotretinoin is a prescription medication used to treat severe recalcitrant nodular acne.
While isotretinoin is beneficial for some patients, there are risks associated with this drug. Specifically, isotretinoin is highly teratogenic (i.e., causes severe birth defects) and, therefore, is approved for marketing only under a restricted-distribution risk evaluation and mitigation strategy (REMS), called the iPLEDGE REMS.
Accutane®-Exposed Pregnancies - California, 1999
MMWR Weekly, January 21, 2000/49(02);28-31
Accutane® (Roche Laboratories, Nutley, New Jersey), known by the generic name "isotretinoin," is a prescription oral medication approved by the Food and Drug Administration (FDA) ... It is also a known human teratogen that can cause multiple major malformations. Embryopathy associated with the mother's exposure ... includes craniofacial, cardiac, thymic, and central nervous system malformations ... The total number of reproductive-aged women taking isotretinoin in the United States is unknown; however, 454,273 women enrolled in the BUAS from 1989 to October 1999. BUAS has estimated that 38%-40% of reproductive-aged women taking isotretinoin chose to enroll in the survey ... Approximately 900 pregnancies occurred among BUAS enrollees during 1989-1998 ... Seven (50%) respondents reported viewing an advertisement for prescription acne treatment before taking isotretinoin ... Four live-born infants with no major malformations resulted from these 14 pregnancies. One live-born infant had major malformations. The other pregnancy outcomes were four spontaneous abortions and five induced abortions ... Although all 14 respondents knew that isotretinoin should not be used during pregnancy, none reported seeing all components of the PPP, and four had not seen any component other than the information available on the isotretinoin packet. None of the women reported being referred for contraceptive counseling or being told that they would not have to pay for the counseling ...
Prevention of Micronutrient Deficiencies
National Academies - Sciences, Engineering, Medicine
Tools for Policymakers and Public Health Workers
[for Professionals mainly]
Fetal Isotretinoin Syndrome
Guillermo Font, MD, et al., TheFetus.net, 1999
Current Trends Birth Defects Caused by Isotretinoin --
MMWR weekly March 25, 1988 / 37(11);171-2,177
F. Hoffmann-La Roche and BASF agree to pay record criminal fines for participating in international vitamin cartel
United States Department of Justice, Thursday, May 20, 1999
A Swiss pharmaceutical giant, F. Hoffmann-La Roche Ltd today agreed to plead guilty and pay a record $500 million criminal fine for leading a worldwide conspiracy to raise and fix prices and allocate market shares for certain vitamins sold in the United States and elsewhere, the Department of Justice announced. A German firm, BASF Aktiengesellschaft, also will plead guilty and pay a $225 million fine for its role in the same antitrust conspiracy, the Department said ... The conspiracy lasted from January 1990 into February 1999 and affected the vitamins most commonly used as nutritional supplements or to enrich human food and animal feed -- vitamins A, B 2, B5, C, E, and Beta Carotene ... "These prosecutions demonstrate that we will not allow international cartels to prey on American consumers in our globalized economy," said Attorney General Janet Reno. "Those currently engaged in or contemplating similar conduct should take note of the high cost of getting caught $500 million is not only a record fine in an antitrust case, but it is the largest fine the Justice Department has ever obtained in any criminal case" ... The Department today also charged Dr. Kuno Sommer, former Director of Worldwide Marketing, Hoffmann-La Roche Vitamins and Fine Chemicals Division, with participating in the vitamin cartel and for lying to Department investigators in 1997 in an attempt to cover-up the conspiracy. Dr. Sommer, a Swiss citizen, has agreed to submit to the jurisdiction of the U.S. District Court in Dallas, plead guilty to both charges, serve a four-month prison term, and pay a $100,000 fine ...
Coverage at a crossroads: New directions for vitamin A supplementation programmes
Key facts ...
I.B.I.S. Birth Defects, February 15, 2002
Last Updated: 2023/07/19