Accutane Update (05/22/1990)
Food and Drug Administration's Dermatologic Drugs Advisory Committee
Accutane - a prescription drug approved in l982 - on May 2l underwent its eighth review by FDA's Dermatologic Drugs Advisory Committee (jointly with FDA's Fertility and Maternal Health Advisory Committee on this occasion) ... Beginning in l983 there were reports of severe human birth defects associated with the drug ... Most extensive effort aimed at eliminating birth defects ... was initiated by the manufacturer in late l988, although it was not fully implemented until mid-l989 ... The "Pregnancy Prevention Program" included unprecedented educational
efforts and restrictions ... The voluntary plan also included the initiation of an epidemiological study ... One infant has been reported born with defects in l990, four for l989 and three for l988, compared to 10 for 1987 and 12 for 1986 ...
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 ...
Accutane and Other Retinoids
March of Dimes Birth Defects Foundation
Birth defects associated with Accutane include: hydrocephaly (enlargement of the fluid-filled spaces in the brain), microcephaly (small head), mental retardation, ear and eye abnormalities, cleft lip and palate and other facial abnormalities and heart defects. There also is a high risk of miscarriage for pregnant women taking the drug ... Soriatane (actiretin) is another retinoid marketed by Roche ... Like Accutane, this drug can cause serious birth defects ... As with Accutane, Roche recommends a pregnancy test before starting the drug and use of two reliable forms of contraception during treatment ... Soriatane replaces (and is closely related to) another psoriasis drug called Tegison (etretinate) ...
Prevention of Vitamin A Deficiency
Barbara A. Underwood, Ph.D., National Eye Institute
[for Professionals mainly]
Vitamin A Deficiency - Hypovitaminosis A
W.C. Edmundson et al., India Together
[for Professionals mainly]
Vitamin A deficiency is ranked along with protein calorie malnutrition and iron deficiency anaemia as one of the three top priority nutritional diseases ... Vitamin A blindness is both the easiest and the cheapest major nutritional illness to cure ... Abnormalities of the eye are the main signs of A deficiency in humans ... Bitot's spots foamy pigmentation on the conjunctiva ... seen in preschool children and the elderly ... Xerosis is characterised by a lack of lustre, unwettability by tears, wrinkling and opacity ...
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 ...
A and Birth Defects
Brad Stone, Food and Drug Administration, October 6, 1995
Vitamin A Use During Pregnancy
Teratology Society, 2003
Teratology Society Position Paper, TERATOLOGY 35:269275 (1987). Carotene, e.g., beta-carotene, has not been associated with vitamin A toxic effects. The risk of birth defects owing to synthetic vitamin A analogs has already been documented in humans, excess vitamin A (25,000 IU or more) as retinol/retinyl esters during pregnancy has been associated with some birth defects in a small number of case reports.
Vitamin A - Betacarotene
Elson Haas, M.D., from Staying Healthy with Nutrition: The Complete Guide to Diet and Nutritional Medicine
Preformed vitamin A, as is found in fish liver oil, was the first vitamin officially named and was thereby given the letter A ... Retinol, another name for preformed vitamin A, was so named because of its importance in vision. The rods of the eye contain rhodopsin, or visual purple, and need vitamin A for proper vision. Several carotene pigments found in foods, mainly yellow and orange vegetables and fruits, can be converted to vitamin A in our body and thus are termed provitamin A. Beta-carotene is the most available and also the one that yields the highest amount of A ...
Vitamin A deficiency - a cause of child death that can be easily prevented
The problem of vitamin A deficiency (VAD) is global ...
I.B.I.S. Birth Defects, February 15, 2002
Last Updated: 2007/10/15