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New sleeping pill gets FDA approval, awaits DEA clearance

A new type of prescription sleep aid has won approval from the Food and Drug Administration (FDA) and if given clearance from the Drug Enforcement Administration (DEA) should be commercially available later this year. Belsomra, made by Merck & Co., works by temporarily blocking chemicals in the brain that control sleep cycle and keep people awake at night. The sleeping pill is designed to help people with insomnia to sleep through the night. Belsomra was approved based on trials that pitted the medication against a placebo. It was not tested against other sleep aids, however, so it is not known ... Read More

Long-term safety, efficacy data needed for ADHD drug use in children

Children who are prescribed medication to treat symptoms of attention-deficit hyperactivity disorder, or ADHD, take the drugs for several years. However, there have been no studies to show how effective or safe the medication is for the long-term, or how to detect rare side effects, according to a report in the journal PLOS ONE. According to the Centers for Disease Control and Prevention (CDC), 11 percent of children in the United States between the ages of 4 and 17 – or about 6.4 million – are diagnosed with ADHD. The Food and Drug Administration (FDA) has approved 20 drugs to ... Read More

FDA approves new ‘high-intensity’ sugar substitute

A new zero-calorie sweetener will soon hit store shelves, giving consumers more sugar substitute options to sweeten or add flavor to their foods, the Food and Drug Administration (FDA) announced. The new sweetener is called advatame, but does not yet have an official brand name. Advatame, along with other marketed sugar substitutes, are called high-intensity sweeteners “because small amounts pack a large punch when it comes to sweetness,” says Captain Andrew Zajac, U.S. Public Health Service (USPHS) director of the Division of Petition Review at the Food and Drug Administration (FDA). Unlike sweeteners like sugar, honey or molasses, high-intensity sweeteners ... Read More

FDA approves morning sickness drug pulled from market 30 years ago

A morning sickness treatment pulled from the market 30 years ago amid birth defect fears has been granted approval by the Food and Drug Administration (FDA) for treatment of the pregnancy condition. This week, the FDA approved Diclegis, formerly known as Bendectin, as a safe and effective treatment for nausea and vomiting that often accompany pregnancy. Diclegis is a combination of the vitamin B6 and antihistamine. Reassurance that drugs are safe to use during pregnancy is hard to come by, especially since it is too risky to run clinical trials on pregnant women to determine whether a drug can have ... Read More

Canker sore, asthma drug to be tested as a treatment for obesity, diabetes

A drug used to treat canker sores may one day help patients who are obese or have diabetes, a new study suggests. The drug, amlexanox, was found to increase the basal metabolism of laboratory rats and reverse obesity, diabetes and fatty liver. Amlexanox is a medication with antiallergic and anti-inflammatory effects. It is also used in some countries as a treatment for asthma. Based on the new research, amlexanox has become a candidate for clinical evaluation in the treatment of obesity and related disorders, including diabetes. The study was conducted by researchers with the Life Sciences Institute at the University ... Read More

Drug study data often crunched to mask serious side effects

Clinical drug trials provide important data that help the Food and Drug Administration (FDA) determine if a drug is safe and effective enough to be marketed in the United States for a particular indication. But a new study has found that sometimes drug companies crunch numbers in a way to make a drug look better than it actually is. Researchers at Princess Margaret Cancer Centre reached that conclusion after reviewing data from 164 breast cancer trials. They found that a large number of the studies that reported no real benefit of a particular treatment were spun so that they focused ... Read More

FDA approves Tamiflu for young infants

The Food and Drug Administration (FDA) has approved Tamiflu for infants as young as two weeks who have flu symptoms, even though scientists in Europe are urging European governments to sue its maker because the drug company will not provide evidence that the drug is safe and effective for children and adults. Tamiflu has been approved to treat the flu in adults and children ages 1 year and older who have had symptoms of the flu for less than two days. The drug is also approved to prevent flu in children and adults older than 1 year of age. Though ... Read More

Safety tips and reminders for Baby Safety Month

September is Baby Safety Month, and the perfect time to for parents and caregivers ensure that their baby’s sleep environment is safe and free from potential hazards. “While cribs, bassinets and play yards are the safest places to place your baby to sleep, more than 11 million cribs and numerous bassinets and play yards have been recalled since 2007,” warns the U.S. Consumer Product and Safety Commission (CPSC). Many of these recalls were initiated because defects or design problems created entrapment, smothering or choking hazards. To ensure your baby’s sleep environment is safe, parents can start by checking the CPSC’s ... Read More

Parents should consult with doctor before giving children melatonin as sleep aide

Doctors are warning parents that the dietary supplement melatonin should not be given to children as a sleep aide without careful consultation with a doctor or healthcare practitioner because the supplement has not been clinically proven to be a safe sleep agent in healthy children. Melatonin is a hormone that is secreted in the brain. It is also a naturally occurring compound in plants and microbes. Manufactured melatonin supplements are thought to help people sleep through the night, and thus are an attractive option for parents whose children have trouble with sleep. Melatonin supplements have been available over-the-counter in the ... Read More

Chemical in spray tanners may put users at risk for cancer

Spray tans are considered to be a safer way to get the look of a suntan without damaging the skin or risking skin cancer, but a new report suggests the chemicals found in spray tans may be dangerous as well. Six medical experts in the fields of dermatology, toxicology and pulmonary medicine are speaking out about the potential dangers of a chemical commonly found in spray-on tanners – dihydroxyacetone, or DHA. ABC News pulled together the panel of medical experts to review 10 of the most publicly available studies on DHA. While none of the studies were conducted on humans, ... Read More