The following stories appear in full on today's Vidyya Medical News Service Web site.
Spina bifida and anencephaly are the two most common types of neural tube birth defects. In spina bifida, the spine does not close properly during the first month of fetal development. The effects of spina bifida range from mild, with little or no noticeable disability, to severe, with limited movement and function. Babies with anencephaly are born with most or all of the brain missing. They die before or soon after birth.
For more information: Preventing Neural Tube Defects With Folic Acid: Working For Healthier Babies
Women need to get enough folic acid every day throughout their reproductive years. To prevent NTDs, a woman must take folic acid daily at least one month before she conceives and continue taking it through the first trimester (three months) of pregnancy. All women capable of becoming pregnantnot just those planning a pregnancyshould consume enough folic acid every day, because half of all the pregnancies in the United States are unplanned. Remember, NTDs occur before many women know that they are pregnant.
For more information: Information For Patients: When Do Women Need To Take Folic Acid?
The FDA yesterday proposed a new regulation on current good tissue practice (GTP), which includes the methods, facilities and controls used for the manufacture of human cellular and tissue-based products. This proposed rule is the last of three proposals designed to implement FDA’s 1997 “Proposed Approach to the Regulation of Cellular and Tissue-based Products”, a comprehensive risk-based regulatory framework designed to help ensure the safety and quality of products, including new technologies, without imposing unnecessary regulatory requirements.
For more information: FDA Proposes New Rules For "Good Tissue Practice"
In September 2000, two instances of life-threatening hepatotoxicity were reported in health-care workers taking nevirapine (NVP) for postexposure prophylaxis (PEP) after occupational human immunodeficiency virus (HIV) exposure*. In one case, a 43-year-old female health-care worker required liver transplantation after developing fulminant hepatitis and end-stage hepatic failure while taking NVP, zidovudine, and lamivudine as PEP following a needlestick injury. In the second case, a 38-year-old male physician was hospitalized with life-threatening fulminant hepatitis while taking NVP, zidovudine, and lamivudine as PEP following a mucous membrane exposure. To characterize NVP-associated PEP toxicity, CDC and the Food and Drug Administration (FDA) reviewed MedWatch reports of serious adverse events in persons taking NVP for PEP received by FDA.
For more information: Serious Adverse Events Attributed To Nevirapine Regimens For Postexposure Prophylaxis After HIV Exposures --- Worldwide, 1997--2001
When a medication is in the news, Vidyya obtains the prescribing information for you. Read the full prescribing information for Viramune (nevirapine) in today's issue. The information has been updated to include new safety warnings and is current as of November, 2000.
For more information: Prescribing Information: Viramune (Nevirapine)
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As always, we hope you enjoy the issue.