OxyContin that's harder to abuse? FDA debates new version
WASHINGTON -- The government is evaluating a new version of OxyContin -- the potent painkiller sometimes called "hillbilly heroin" -- designed to be harder to abuse.
A plastic-like coating fuses to the tablet, making it harder to crush -- and turning into a gooey mess if abusers try to inject it, maker Purdue Pharma LP said in documents released by the Food and Drug Administration on Thursday.
The FDA will ask its scientific advisers this week if the reformulated drug seems tamper-resistant enough to allow on the market before the required long-term studies are done to see if the changes thwart at least some abuse.
OxyContin was hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. A time-release version of the old narcotic oxycodone, it was designed to be swallowed whole and digested over 12 hours to keep a steady state of the painkiller in the bodies of seriously ill patients.
But abusers rapidly discovered the tablets can produce a heroin-like high if crushed and snorted or injected, thus dumping the dose all at once instead of letting it seep in slowly.
Purdue Pharma said its laboratory studies show the new OxyContin is equivalent to the original in how well the painkiller dissolves, if used correctly.
If someone tries to crush it, the plastic-like coating makes the tablet more likely to break into large fragments instead of a powder, the Stamford, Conn.-based company wrote. The coating renders the drug "a gelatinous mess" when mixed with alcohol or other solvents in attempts to dissolve and inject it, the documents say.
Two other companies, Pain Therapeutics Inc. and King Pharmaceuticals, also are developing an abuse-resistant form of the drug. Called Remoxy, it would provide a thick gelatin-like version of oxycodone.
CDC: Three out of four new moms in U.S. now breast-feed their infants
ATLANTA -- More than three out of four new moms now breast-feed their infants, the highest rate in the United States in at least 20 years, according to a government report released last week.
About 77 percent of new mothers breast-feed, at least briefly, up from 60 percent in 1993-1994, the Centers for Disease Control and Prevention said.
"It looks like it is an all-time high" based on CDC surveys since the mid-1980s, said Jeff Lancashire, a CDC spokesman.
Experts attributed the rise to education campaigns that emphasize that breast milk is better than formula at protecting babies against disease and childhood obesity. A changing culture that accommodates nursing mothers may also be a factor.
The percentage of black infants who were breast-fed rose most dramatically, to 65 percent. Only 36 percent were ever breast-fed in 1993-1994, the new study found.
For whites, the figure rose to 79 percent, from 62 percent. For Mexican-Americans, it increased to 80 percent, from 67 percent.
The new report is based on a comprehensive federal survey involving in-person interviews and physical examinations. The findings are based on information for 434 infants from the years 2005 and 2006.
A telephone survey of thousands of families, released last year, found that 74 percent of infants in 2004 had been breast-fed.
At least three types of CDC surveys have shown breast-feeding rates moving upward since the early 1990s, officials said.
The latest CDC report found rates of breast-feeding were also lowest among women who are unmarried, poor, rural, younger than 20, and have a high school education or less.
Diabetes before motherhood on the rise, Calif. study shows
LOS ANGELES -- The number of pregnant women with pre-existing diabetes has more than doubled in seven years, a California study found, a troubling trend that means health risks for both mothers and newborns.
And the number of diabetic teenagers giving birth grew fivefold during the same period, according to the study, the largest of its kind.
Expectant mothers who don't control their diabetes face an increased risk of miscarriage and stillbirth. Their babies have a higher chance of being born with birth defects.
"These are high-risk pregnancies," said Dr. Florence Brown, an expert on pregnancy and diabetes. "All women with pre-existing diabetes need to plan their pregnancies."
The researchers focused on health records from more than 175,000 ethnically diverse women who gave birth in a dozen Kaiser hospitals in Southern California from 1999 to 2005. Experts believe the findings likely reflect the overall U.S. population.
The rate increased the greatest among 13- to 19-year-olds giving birth. It ballooned from about 1 per 1,000 pregnancies to 5.5 per 1,000 during the seven-year period.
Blacks, Asians and Hispanics were more likely to have diabetes before pregnancy than whites.
The rise of diabetes among women of childbearing age mirrors the prevalence of the disease in the general population. The most common form of diabetes is Type 2, which is linked to obesity.
Results of the study were published last week in the journal Diabetes Care, a publication of American Diabetes Association, which funded the research.
Heart exam, EKG recommended before children get ADHD drugs
NEW YORK -- Children should be screened for heart problems with an electrocardiogram before getting drugs like Ritalin to treat hyperactivity and attention-deficit disorder, the American Heart Association recommended last week.
Stimulant drugs can increase blood pressure and heart rate. For children with heart conditions, it could make them more vulnerable to sudden cardiac arrest and other heart problems.
About 2.5 million American children and 1.5 million adults take medication for attention-deficit hyperactivity disorder, or ADHD, according to government estimates. Stimulant drugs, like Ritalin, Adderall and Concerta, help children with ADHD stay focused and control their behavior.
The medications already carry warnings of possible heart risks in those with heart defects or other heart problems, which some critics said were driven more by concerns of overuse of the drugs than their safety.
The heart group is now recommending a thorough exam, including a family history and an EKG, before children are put on the drugs to make sure that they don't have any undiagnosed heart issues.
An EKG can detect abnormal heart rhythms that can lead to sudden cardiac arrest.
Dr. Steven Pliszka, a child psychiatrist at the University of Texas in San Antonio, said he was baffled by the EKG recommendation. He said there's no evidence that sudden death is a bigger problem for children taking stimulants than for children who aren't taking the drugs.
Pliszka said an EKG might deter people from seeking treatment because it's an added expense and hassle.