Children's Care a 'Gap' in U.S. Pandemic Plans: Report
U.S. government plans for a flu pandemic have major gaps in terms of treating and caring for children, says a report released Wednesday by the American Academy of Pediatrics and the Trust for America's Health (TFAH).
The report noted that children ages 0-19 account for nearly 46 percent of all deaths caused by the H5N1 bird flu virus.
"Children are not simply small adults, especially when it comes to medical concerns. The fact the H5N1 has been disproportionately impacting children and adolescents should give us pause," Jeff Levi, TFAH executive director, said in a prepared statement. "As the U.S. prepares for the threat of a possible pandemic flu, we must make caring for our kids a priority, not an afterthought."
The report identified four major areas of concern: child-appropriate doses of vaccine and medications; management and treatment of children who become ill; inclusion of children in strategies to slow the spread of influenza in communities; and caring for and supervising the health of children if schools and childcare facilities are closed for extended periods of time.
Diabetes Drug Byetta Linked to Acute Pancreatitis
Doctors and patients are being warned that the diabetes drug Byetta may cause acute pancreatitis, an inflammation of the pancreas that can be fatal, the Wall Street Journal reported.
The U.S. Food and Drug Administration issued the alert after it reviewed 30 cases of acute pancreatitis that have been reported since Byetta was approved for sale in the U.S. in 2005.
The drug is marketed by Amylin Pharmaceuticals Inc. of San Diego and Eli Lilly & Co. of Indianapolis. Amylin has agreed to update Byetta's label to provide clear advice on the signs and symptoms of acute pancreatitis that doctors should look for, the Wall Street Journal reported. Those signs include persistent, severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Tests are needed to confirm the condition, the FDA said.
Patients should stop taking Byetta if pancreatitis is suspected, the agency said. If the condition is confirmed, patients shouldn't start taking the drug again until the cause of the pancreatitis is found.
Egg Freezing Shouldn't Be Offered to Healthy Women, Experts Say
Egg freezing shouldn't be marketed or offered to healthy women who want to delay having children until later in life, says a joint statement issued Tuesday by the American Society for Reproductive Medicine and the American Society for Assisted Reproductive Technologies.
The statement said the procedure is still too experimental and healthy women seeking egg freezing should receive counseling that clearly explains the many downsides of the procedure, including the fact that only two to four percent of frozen eggs produce a live birth, the Canadian Press reported.
Experts are worried that healthy women who want to freeze eggs so they can have children later in life may not have an accurate idea of the low success rates, said Dr. Marc Fritz, chair of the committee that prepared the policy statement.
He also noted that the science of egg freezing is still new and little is known about whether babies born from frozen eggs are healthy, both at birth and over the long term, the CP reported.
Average Cost of Having a Baby in U.S. now $7,600
The average cost of having a baby in the United States has now topped $7,600, according to the latest News and Numbers summary from the federal Agency for Healthcare Research and Quality (AHRQ).
The cost, in 2004 dollars, includes payments for prenatal office visits, prescription medicines, hospital childbirth, and other services.
Among the other findings in the summary:
Women with private insurance and those with Medicaid had about the same average costs ($2,000) for prenatal care. However, inpatient delivery costs for those with private insurance averaged $6,520, compared with $4,577 for those on Medicaid.
Privately insured women paid about eight percent of their total expenses out of pocket (about $600 for a woman with an average level of expenses), while women on Medicaid paid about one percent out of pocket.
About 23 percent of all women had some prescription drug expenses associated with their pregnancy. The median amount of the expenses was $640. About three-quarters of all prescription drug expenses were for nutritional products such as prenatal vitamins.
FDA Approves New Breast Cancer Drug
A new chemotherapy drug called Ixempra received U.S. Food and Drug Administration approval Tuesday for treatment of women with advanced breast cancer who haven't responded to treatment with three other types of chemotherapy.
The drug, made by Bristol-Myers Squibb Co., was also approved for use with the chemotherapy drug capecitabine (brand name Xeloda) for treatment of women with breast cancer that's spread to other parts of the body, the Wall Street Journal reported.
Ixempra was granted priority review status by the FDA. This status, which cuts four months off the standard 10-month drug review time, is given to products that are considered to be an advance over existing therapies on the market.
Ixempra, which belongs to a new class of drugs called epothilones, is designed to stop the growth of cancer cells. It does this by targeting a protein called tubulin that helps cells proliferate, the Wall Street Journal reported.
Bristol-Myers is also studying the use of Ixempra for treatment of earlier-stage breast cancer, as well as ovarian, prostate, renal, pancreatic and non small cell lung cancers.
FDA Panel Supports Earlier Use of Phosphate Binders Against Kidney Disease
Earlier use of drugs called phosphate binders to treat hyperphosphatemia (elevated levels of phosphorus in the blood) in patients with Stage 4 chronic kidney disease was recommended Tuesday by a U.S. Food and Drug Administration advisory committee.
However, the Cardiovascular and Renal Drugs Advisory Committee didn't reach consensus on which additional studies may be required, according to a news release from Shire Pharmaceuticals, which makes a product to treat hyperphosphatemia. The FDA is not required to follow the advisory panel's recommendation. No time frame has been set on when the FDA will make a decision on the committee's recommendation.
Normal adult blood phosphorus levels are 2.5 to 4.5 milligrams per deciliter, but levels in patients on dialysis often exceed 6.5 mg/dL. Hyperphosphatemia can cause bone pain, brittle bones, skeletal deformities and fractures, as well as calcification of vascular and other soft tissues. The condition also contributes to cardiovascular disease, which accounts for nearly half of all deaths among dialysis patients.
The National Kidney Foundation recommends that monitoring for hyperphosphatemia should begin in patients with Stage 3 chronic kidney disease (CKD) and that serum phosphorus levels should be maintained within a target range of 2.7 to 4.6 mg/dL in patients with CKD Stages 3 and 4, and within a range of 3.5 to 5.5 mg/dL for patients with CKD Stage 5.