Many U.S. Adults Don't Get Enough Rest or Sleep
Only 29.6 percent of adults in four states (Delaware, Hawaii, New York and Rhode Island) reported no days of insufficient rest or sleep in the past 30 days, and 10.1 percent reported insufficient rest or sleep every day during the past month, according to a study that analyzed 2006 Behavioral Risk Factor data collected in those states.
The study also found that 24.8 percent of adults unable to work were more likely to have insufficient rest or sleep. The findings are outlined in this week's Morbidity and Mortality Weekly Report, published by the U.S. Centers for Disease Control and Prevention.
The article noted that 50 million to 79 million Americans suffer from chronic sleep disorders. Sleep disorders and sleep loss may be associated with mental distress, depression, anxiety, obesity, hypertension, diabetes, high cholesterol and certain risk behaviors such as smoking, heavy drinking and physical inactivity, the article added.
More studies and data are needed to assess the prevalence and national impact of insufficient rest or sleep on adults, the article said. Adults need seven to nine hours of sleep a night, according to the National Sleep Foundation.
FDA Approves Nexium for Young Children
The drug Nexium (esomeprazole magnesium) has been approved for short-term treatment of children ages one to 11 years with gastroesophageal reflux disease (GERD), the U.S. Food and Drug Administration said Thursday.
The approval includes delayed-release capsule and liquid forms of the drug.
Nexium belongs to a class of drugs called proton pump inhibitors (PPIs), which decrease stomach acid production and help heal erosions in the lining of the esophagus (erosive esophagitis).
The FDA said children prescribed this drug should be monitored by their doctors for side effects, which may include headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness.
New Drug Approved to Treat Rare Inflammatory Disorders
The injected drug Arcalyst has been approved by the U.S. Food and Drug Administration for treatment of two rare cryopyrin-associated periodic syndromes, the Associated Press reported.
The inherited disorders, which affect about 300 people in the United States, can cause symptoms including joint pain, rashes and fever. One of them can also cause hearing loss and deafness.
Arcalyst, made by Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y., works by blocking a protein that can trigger inflammation. Respiratory infections and rashes at the injection site are the most common side effects associated with the drug.
The drug's approval came under the FDA's orphan-drug program, which gives companies seven years of exclusive marketing rights in return for developing treatments for rare diseases, the AP reported.
Cribs Recalled for Fall Risks
U.S. safety officials announced a recall of 24,000 Indonesian-made cribs on Thursday.
The wooden cribs, imported by Munire Furniture Inc. of Piscataway, N.J., have faulty brackets that don't allow the mattresses to be fully lowered. This could let children inside the cribs crawl over the railing and fall. No falls or injuries have been reported yet, the Consumer Product Safety Commission said.
The recalled cribs include: Majestic Curved Top cribs with model number 9500; Majestic Flat Top cribs with model number 9000; Essex cribs with model number 7100; Brighton/Sussex cribs with model number 9100, and Captiva cribs with model number 5100. Only cribs with manufacture dates between Nov. 1, 2005, and Nov. 1, 2007, are included in the recall.
Also Thursday, the CPSC warned that placing pillows and other soft bedding in babies' cribs is dangerous.
From 2002 to 2004, nursery products were involved in the deaths of 241 U.S. children under age 5, according to the CPSC. Of those incidents, about 40 percent involved cribs, with soft bedding cited as the major contributing factor. In many of those cases, children suffocated while lying face down on pillows or other bedding, the Associated Press reported.
Cribs should be free of adult pillows and blankets, stuffed animals and baby quilts, said CPSC spokeswoman Julie Vallese. In addition, babies should be placed on their backs in a crib that meets current safety standards.
Babies becoming trapped in ill-fitting crib mattresses can also lead to deaths. The CPSC said there should never be a gap larger than two fingers at any point between the sides of the crib and the mattress, and old, broken and modified cribs shouldn't be used, the AP reported.
From 2002 to 2004, there were 36 baby deaths related to baby baths and bath seats. In all those cases, the deaths occurred when caregivers left the baby unattended, the CPSC said.
FDA Needs More Inspectors to Monitor Foreign Firms, Official Says
More inspectors and a comprehensive computer database are needed to help the U.S. Food and Drug Administration improve its monitoring of foreign-made drugs and drug ingredients entering the United States, an agency official told U.S. lawmakers Wednesday.
Due to limited resources, the FDA each year inspects only about 10 percent (300) of foreign facilities that ship drugs and drug ingredients to the United States, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, the Associated Press reported.
During her appearance before an appropriations panel responsible for funding the FDA, Woodcock was asked what additional resources the agency needed. While Woodcock often did not provide specifics, she did say that hiring more investigators and upgrading the agency's computer systems would be the top priorities if more money were made available, the AP said.
Under the Bush administration, funding for foreign inspections has decreased nearly 30 percent, even though the number of firms to be inspected has increased, noted panel chair Rep. Rosa DeLauro (D-Conn.), the news service reported.
A Government Accountability Office report released last November said the FDA doesn't know how many foreign firms are actually subject to inspection.
Panel No Longer Prefers ProQuad Vaccine
A Merck & Co. combination vaccine for measles, mumps, rubella and chickenpox caused higher rates of fever-related convulsions in children than two separate injections (one for chickenpox and another for the three other diseases), according to a U.S. study released Wednesday.
As a result of the finding about the combination vaccine ProQuad, the federal Advisory Committee on Immunization Practices moderated its preference for the vaccine, which received Food and Drug Administration approval in 2005, the Associated Press reported.
The study of children ages 12 months to 23 months found the rate of seizures was twice as high in children who received ProQuad, compared to those who received the two injections. That works out to about one extra case of convulsions for every 2,000 doses of ProQuad given to children, said researchers who presented the findings Wednesday at a meeting of the advisory committee.
Until Wednesday, the panel had said the ProQuad vaccine was preferable to giving children separate shots. But the new findings prompted the panel to amend its position and state that it no longer has a preference for the combo vaccine over the separate shots, the AP reported.