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Back To Vidyya American Women Suffering From Morning Sickness Do Not Have Access To Same Medications As Other Women

Effective Medication Withdrawn From Market, But Not For Safety Reasons

At the conclusion of a special session hosted by The Reproductive Toxicology Center (RTC) as a satellite conference of the World Conference FIGO 2000 (International Federation of Obstetricians and Gynecologists), Dr. Anthony Scialli, head of the Center, stated that science and medical thinking have made significant progress in recognizing the potentially adverse health effects of untreated pregnancy-induced nausea and vomiting on the women and their babies.

According to Dr. Scialli, recognizing this disorder as a medical condition is a breakthrough in itself, since the symptoms of nausea and vomiting of pregnancy (NVP), commonly called "morning sickness", had long been associated with the pregnant woman's state of mind and therefore treatment was considered to be unnecessary.

The Conference's host stated that "Although NVP is often considered a normal part of the pregnancy, it is important for the medical community to realize that, aside from the economic burden associated with untreated persistent symptoms, NVP also affects the physical, social and psychological state of the pregnant woman and her family."

Dr. Janine E. Polifka, a member of the Session's panel of speakers and Project Director of the Teratogen Information System, stressed the fact that "many physicians are reluctant to prescribe antiemetic medications during pregnancy, particularly since symptoms associated with NVP occur during the first trimester when the embryo is particularly vulnerable to the potentially teratogenic effects of drug."

Dr. Polifka also pointed out that "the only FDA-approved drug for NVP is Bendectin (doxylamine/vitamin B6), and that the best data available regarding fetal safety are still for this compound. But American women have been deprived of Bendectin since 1983, when its manufacturer decided to discontinue its production because of the litigation cost resulting from unsubstantiated claims of birth defects allegedly associated with the drug. Although Diclectin(R) (the generic version of Bendectin) is approved and available in Canada as the only first line pharmacological treatment specifically labelled for nausea and vomiting of pregnancy, there is no commercial version of the compound currently available in the United States."

Dr. Scialli concluded by stating that "American women suffering from nausea and vomiting of pregnancy should benefit from scientific and medical progress. They should have access to the best health care and proven-safe treatments to prevent further problems for them and for their babies. Therefore I am happy that the FDA has reconfirmed that Bendectin was not withdrawn from sales for reason of safety or effectiveness. This evidence- based determination may permit FDA to approve new drug applications for the combination product doxylamine/vitamin B6."

Dr. Scialli added that "NVP has become such an important issue in the United States that the National Institute of Child Health and Human Development has convened a group of experts to discuss this issue during a special conference which will take place on September 20th and 21st."

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Editor: Susan K. Boyer, RN
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