MedNews

You are here: Home / Archives for Health & Medical News

Epilepsy Drug Topiramate May Increase Birth Defect Risk

By 2 Comments

New data suggest that the drug Topamax and its generic versions (topiramate) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

[Read more…]

Hypertension Drug Letairis Gets New Boxed Warning: No Monthly Liver Enyme Test Required

By Leave a Comment

Monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), according to the U.S. Food and Drug Administration (FDA). The drug is used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and post-market reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning. [Read more…]

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

By Leave a Comment

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

By Leave a Comment

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

By Leave a Comment

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%

By Leave a Comment

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)

By Leave a Comment

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…]

3-D Mammography Imaging System Approved

By Leave a Comment

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

By Leave a Comment

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.
[Read more…]

Spina Bifida Complications Reduced by Surgery on Fetus

By Leave a Comment

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…]