Hard Pill to Swallow

Hard Pill to SwalloW A History of Birth Defects Caused by Prescription Drugs 1930 Despite regulations, drug companies still found ways to get harmful products to President Roosevelt signs the new Food, Drug, and Cosmetic Act into law, increas- ing federal regulatory and mandating a pre- market review of the safety of all new drugs. market. TWO out of THREE 1940 women take prescription medications during pregnancy Beginning in the 1940's and over the course of the next three decades, Diethylstilbestrol is given to reduce pregnancy complications. The FDA later withdraws this medication as it is found to cause tumors in fernals who were exposed to Diethylstilbestrol in utero. Top 5 Causes of Infant Deaths 1950 Birth Defects Newly patented compunds lead to the develop- ment of Trimethadione, an anticonvulsant 5,819 known to cause facial deformaties and a reported fetal death rate of up to 87%. Low Birth Weight 4,841 SIDS 2,323 Use of Thalidomide results in more than 10,000 children born with physical deformaties in 46 countries. The FDA refused approval of the drug, however, millions of tablets were distributed to physicians during a clinical testing program. Complications 1,683 1960 Unintentional Injuries 1,147 Word of the Day Discovery of the anticonvulsant properties of valproie acid leads to the development of Depakote which is linked to both spina bifida and risk of autism. Ter-a-tol-o-gy The study of abnomalities of physiological development. Teratology is often thought of as the study of birth defects. 1970- Prozac (Fluoxetine) is first submitted to the FDA for approval. Category X The FDA has a classification system to aid with the assesament of the risk of fetal The FDA introduces their system for classification of fetal risks due to injury due to pharmaceuticals. pharmaceuticals. Drugs listed aa Pregnancy Category X have demonstrated that fetal risks involved in use of the drug in pregnant women outweigh potential benehts. 1980 ... ...... ... . Between 1982 and 2003, more than 2,000 women became pregnant while taking Accutane (Isotretinoin). Most of these preg- nancies result in abortion or miscarriage. Contraception & Category X Methotrexate is approved by the FDA to treat rheumatoid arthritis. Methotrexate is commonly used as an abortifacient to termi- nate pregnancies during the early stages. 40% of reproduetive-age women using both an oral contraceptive anda "Category A Paxil (Paroxetine) hits the market to treat major depression. y X" drug are not taking the contraceptive regu larly and are risking pregnaney. Un-Honorable Mentions A short list of other preseription drugs known to inerease the risk of birth defects. 2000 Busulfan, Enalapril, Lithtum Methimazole, Penicillamine Phenytoin, Temazepam FDA warns that Paxil (Paroxetine ) may increase risk of cardiovasecular malformations, primarily ventricular and atrial septal defects in unborn babies. Study reveals that taking Prozac (Flaoxetine) during the third trimester of pregnancy more than doubles the risk of delivering a child w a rare but potentially fatal condition called Persistent Pulmonary Hypertension of the Newborn (PPHN). The Hangover Cure During the 1990's, certais lemon-lime soft drinks contained lithium and were marketed as a remedy for hangovers, FDA notifed healtheare professionals and patients of an increased risk of development of cleft lip and cleft palate in infants born to women treated with Topamax (Topiramate) Sources NeuralTubeDefect.com Designed by Christopher Uryga 2005 9007 1992| 1988 1982 1979 1977 1962 50's-60's 1951 1940's 1938 LLOZ