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Opioids in Early Pregnancy Doubles Risk of Birth Defects, Says Study

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Babies born to women who take opioid pain killers such as codeine, oxycodone or hydrocodone just before or in early pregnancy are at increased but modest risk of birth defects, according to a study conducted by the Centers for Disease Control and Prevention.

The study, published in the American Journal of Obstetrics and Gynecology, found 2-3 percent of mothers interviewed were treated with prescription opioid pain killers, or analgesics, just before or during early pregnancy. The study did not examine illicit use of these medications. [Read more…]

New Drug (Daliresp) to Treat COPD Approved

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The U.S. Food and Drug Administration approved roflumilast (Daliresp), a pill taken daily to decrease the frequency of flare-ups  or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States. [Read more…]

ICU Bloodstream Infections Decline Dramatically

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The number of bloodstream infections in intensive care unit patients with central lines decreased by 58 percent in 2009 compared to 2001, according to the Centers for Disease Control (CDC). During these nine years, the decrease represented up to 27,000 lives saved and $1.8 billion in excess health care costs. Bloodstream infections in patients with central lines can be deadly, killing as many as 1 in 4 patients who gets one.

A central line is a tube usually placed in a large vein of a patient’s neck or chest to deliver treatment in an intensive care unit, elsewhere in the hospital, and during dialysis. A bloodstream infection can happen when germs enter the blood through a central line, often because proper procedures were not used while the central line was placed or maintained. In recent years, studies have proven that health care providers can prevent most bloodstream infections in patients with central lines by following CDC infection control recommendations, which include removing central lines as soon as medically appropriate. In hemodialysis patients, central lines should only be used when other options are unavailable.

“Preventing bloodstream infections is not only possible, it should be expected. Meticulous insertion and care of the central line by all members of the clinical care team including doctors, nurses and others at the bedside is essential. The next step is to apply what we’ve learned from this to other health care settings and other health care-associated conditions, so that all patients are protected,” said Thomas R. Frieden, M.D., M.P.H., CDC director. [Read more…]

Smoking While Pregnant Raises Risk of Infant Heart Defects by Up to 70%

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Maternal cigarette smoking in the first trimester was associated with a 20 to 70 percent greater likelihood that a baby would be born with certain types of congenital heart defects, according to a study by the Centers for Disease Control and Prevention. Congenital heart defects are the most common type of birth defects, contributing to approximately 30 percent of infant deaths from birth defects annually.

The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics. [Read more…]

New Drug, Edarbi, Approved to Treat High Blood Pressure (Hypertension)

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The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan). [Read more…]

Test for Kidney Transplant Management Cleared by FDA

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The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants

Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.. [Read more…]

3-D Mammography Imaging System Approved

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The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous. [Read more…]

Recommendation for Drinking Water Flouride Levels Revised

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The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water.
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Spina Bifida Complications Reduced by Surgery on Fetus

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A surgical procedure to repair a common birth defect of the spine, if undertaken while a baby is still in the uterus, greatly reduces the need to divert, or shunt, fluid away from the brain, according to a recent study. The surgical procedure consists of closing an opening at the back of the fetal spine. The fetal surgery is a departure from the traditional approach, which involves repairing the defect in the spinal column after an infant has been born.
[Read more…]

New Pacemaker Can Be Used Safely During MRI Exams

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The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods. [Read more…]