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Health & Fitness (231)

 

WASHINGTON (AP) -- The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.

The move comes more than a decade after the Drug Enforcement Administration first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and state and federal lawmakers.

For decades, hydrocodone has been easier to prescribe, in part because it is only sold in combination pills and formulas with other non-addictive ingredients like aspirin and acetaminophen.

That ease of access has made it many health care professionals' top choice for treating chronic pain, everything from back pain to arthritis to toothaches.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. The ingredient is found in blockbusters drugs like Vicodin as well as dozens of other generic formulations.

It also consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the DEA, alongside oxycodone. Both belong to a family of drugs known as opioids, which also includes heroin, codeine and methadone.

Earlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

The FDA has long supported the more lax prescribing classification for hydrocodone, which is also backed by professional societies like the American Medical Association.

But the agency's top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: "The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified to Schedule II, patients will only be able to receive one 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants.

The FDA's request for reclassification must be approved by officials in other agencies within the Department of Health and Human Services.

News of the FDA decision was applauded by lawmakers from states that have been plagued by prescription drug abuse, many who have been prodding the agency to take action for months.

"Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country," said Democratic Sen. Joe Manchin, in a statement. "Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities

Sen. Charles Schumer of New York noted that the FDA's own expert panel recommended the reclassification more than nine months ago.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," Schumer said in a statement.

Still, Thursday's action immediately sparked criticism from some professional groups that said that the tighter restrictions could have unintended consequences, such as burdening health care workers and patients.

"The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," said Kevin Schweers, a spokesman for the National Community Pharmacists Association.

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.

Monday, 28 October 2013 10:47
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   CHICAGO (AP) - Doctors are sending a warning to new mothers who feed their babies with breast milk purchased online.

   A new study says testing shows the breast milk can contain potentially dangerous bacteria including salmonella.

   Researchers bought and tested more than 100 breast milk samples sold by women on one popular site, and 75 percent of those samples contained high amounts of bacteria that could sicken babies. Researchers did not identify the website.

   The research also cites several cases in which babies did get sick from a stranger's breast milk.

   Breast milk also is provided through milk banks, whose clients include hospitals. But they screen donors and pasteurize donated milk to kill any germs.

   Both online breast milk sites and milk banks charge fees.

 
Monday, 21 October 2013 01:15
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   BOSTON (AP) — New research suggests that high levels of BPA, a chemical in many plastics and canned food linings, might raise the risk of miscarriage in women prone to that problem or having trouble getting pregnant.

   The work is not nearly enough to prove a link, but it adds to "the biological plausibility" that BPA might affect fertility and other aspects of health, said Dr. Linda Giudice, a California biochemist who is president of the American Society for Reproductive Medicine. The study was to be presented Monday at the group's annual conference in Boston. Last month, ASRM and an obstetricians group urged more attention to environmental chemicals and their potential hazards for pregnant women.

   BPA, short for bisphenol-A, and certain other environmental chemicals can have very weak, hormone-like effects. Tests show BPA in nearly everyone's urine, though the chemical has been removed from baby bottles and many reusable drink containers in recent years. The federal Food and Drug Administration says BPA is safe as used now in other food containers.

   Most miscarriages are due to egg or chromosome problems, and a study in mice suggested BPA might influence that risk, said Dr. Ruth Lathi, a Stanford University reproductive endocrinologist.

   With a federal grant, she and other researchers studied 115 newly pregnant women with a history of infertility or miscarriage; 68 wound up having miscarriages and 47 had live births.

   Researchers analyzed blood samples from when the women were discovered to be pregnant and divided them into four groups based on BPA levels. Women in the top quarter had an 80 percent greater risk of miscarriage compared to those in the bottom group even though they were similar in age and other factors. However, because the study is relatively small, there was a big range of possible risk — from only slightly elevated to as much as 10 times higher.

   "It may be that women with higher BPA levels do have other risk factors" for miscarriage that might be amplified by BPA, Lathi said.

   The study is not cause for alarm, but "it's far from reassuring that BPA is safe" for such women, she said.

   To minimize BPA exposure, avoid cooking or warming food in plastic because heat helps the chemical leak out, she said. Don't leave water bottles in the sun, limit use of canned foods and avoid handling cash register receipts, which often are coated with resins that contain BPA.

   "It's impossible to avoid it completely," Lathi said.

   ___

   Online:

   BPA info: http://1.usa.gov/QHrkfN

   Infertility info: http://www.sart.org and

   http://www.asrm.org

Monday, 14 October 2013 03:06
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WASHINGTON (AP) -- Little Amelia Sloan became a pioneer shortly after her birth.

The healthy baby is part of a large research project outside the nation's capital that is decoding the DNA of hundreds of infants. New parents in a few other cities soon can start signing up for smaller studies to explore what's called genome sequencing - fully mapping someone's genes to look for health risks - should become a part of newborn care.

It's full of ethical challenges.

Should parents be told only about childhood threats? Or would they also want to learn if their babies carried a key gene for, say, breast cancer after they're grown? Could knowing about future risks alter how a family treats an otherwise healthy youngster? And how accurate is this technology - could it raise too many false alarms?

This is the newest frontier in the genetic revolution: how early to peek into someone's DNA, and how to make use of this health forecast without causing needless worry.

"This was something that was looming over the horizon," said Dr. Alan Guttmacher, a pediatrician and geneticist who heads the National Institutes of Health's child health division. Last month, NIH announced a $25 million, five-year pilot project in four cities - Boston, San Francisco, Chapel Hill, N.C., and Kansas City, Mo. - to start answering some of the questions before the technology is widely offered for babies.

Today, the 4 million U.S. babies born annually have a heel pricked in the hospital, providing a spot of blood to be tested for signs of at least 30 rare diseases. This newborn screening catches several thousand affected babies each year in time for early treatment to prevent death, brain damage or other disabilities. It's considered one of the nation's most successful public health programs.

A complete genetic blueprint would go well beyond what that newborn blood spot currently tells doctors and parents - allowing a search for potentially hundreds of other conditions, some that arise in childhood and some later, some preventable and some not.

"If I truly believed that knowing one's genome was going to be transformative to medicine over the next decade or more, then wouldn't I want to start generating that information around the time of birth?" asked Dr. John Niederhuber, former director of the National Cancer Institute who now oversees one of the largest baby-sequencing research projects to date.

At Niederhuber's Inova Translational Medicine Institute in Falls Church, Va., researchers are mapping the genomes of newborns, along with their parents and other relatives for comparison. The long-term goal of the privately funded study is to uncover genetic patterns that predict complex health problems, from prematurity to developmental disorders.

But the experimental tests will turn up some gene mutations already well-known to cause serious ailments, and participating parents must choose upfront whether to be told. They don't get a full report card of their baby's genes. Only ones that cause treatable or preventable conditions - so-called medically actionable findings - are revealed, to the family's doctor. That means in addition to pediatric diseases, parents also could learn whether a baby carries a particular breast-cancer-causing gene, information useful once she reaches young adulthood.

Nurse Holly Sloan was eager to enroll daughter Amelia, although she thought hard about how she'd handle any bad news.

"If it was something that we could hopefully prevent through diet or exercise or some kind of lifestyle change, we could start with that as early as possible," said Sloan, of Warrenton, Va. "I guess I'm just the type of person, I would rather know and address it." Five months after Amelia's birth, she hasn't gotten any worrisome results.

Until now, genome sequencing has been used mostly in research involving curious adults or to help diagnose children or families plagued by mysterious illnesses.

But many specialists say it's almost inevitable that DNA mapping eventually will be used for healthy young children, too, maybe as an addition to traditional newborn screening for at least some tots. It takes a few drops of blood or a cheek swab. And while it's still too costly for routine use, the price is dropping rapidly. Whole genome sequencing is expected to soon come down to $1,000, what it now costs for a more targeted "exome" sequencing that maps only certain genes and may be enough.

The NIH decided this was a window of opportunity to explore different ways this technology might be used. One of the four teams - at Children's Mercy Hospital in Kansas City - will test rapid gene-mapping to speed diagnosis of sick babies in intensive care.

Another will look for narrow sets of genes important in childhood, such as those involved with immune disorders not detected by today's newborn screening or that alter how a child processes medication. "It's not going to be some sort of fishing expedition throughout the genome," said Dr. Robert Nussbaum of the University of California, San Francisco.

The two other projects - at Brigham and Women's Hospital in Boston and the University of North Carolina, Chapel Hill - will go a step further by enrolling healthy infants as they explore what kind of information parents want about their babies' future.

"We aren't even sure that genome-scale sequencing in newborns is really a good idea," cautioned UNC lead researcher Dr. Jonathan Berg in a recent Facebook chat to alert the community about the study. Rather than a one-time mapping, it's possible that "we will use targeted sequencing at certain times in a person's life, when that specific information will actually be medically useful."

For those pioneering babies whose DNA is being mapped already, researchers are "trying to figure out what is legal, versus ethical, versus good medicine" in revealing results, said geneticist Joe Vockley, Inova Translational Medicine Institute's chief science officer.

Mom and Dad may be told something their child, once grown, wishes hadn't been revealed. Other findings may be withheld now that would be good to know years later, as new treatments are developed.

"This is a living, breathing problem," Vockley said, "not a static decision that's made, and it lasts for all time."

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.

Wednesday, 09 October 2013 11:03
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   CHICAGO (AP) - A television pitchman accused of pushing false information during his late-night infomercials could avoid jail because of the government shutdown.

   The Federal Trade Commission sued Kevin Trudeau, alleging he made misleading statements about his weight-loss books. Trudeau says he's unable to pay a $37 million judgment, and the FTC wants him jailed until he proves his financial assets.

   But because of the government shutdown, FTC lawyers aren't getting paid. They were expected to ask a judge during a Friday hearing in Chicago to jail Trudeau, but they requested that the hearing be indefinitely delayed.

   The judge briefly jailed Trudeau last month and warned he could do it again.

   Trudeau's attorney didn't return a message Thursday. A voicemail for FTC lawyers said they couldn't respond until "the government ... resumes operation."

 

Friday, 04 October 2013 02:41
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SACRAMENTO, Calif. (AP) — Overloaded websites and jammed phone lines frustrated consumers for a second day as they tried to sign up for health insurance under the nation's historic health care overhaul.

That was putting pressure on the federal government and the states that are running their own insurance exchanges to fix the problems amid strong demand for the private insurance plans.

"I think I'm through with Hawaii Health Connector," said Richard Gamberg, 61, of Honolulu, after tweeting messages to officials and complaining to state lawmakers on Wednesday. "They've got ads in the newspaper, they've got ads on the TV — it just flabbergasts me."

He was among the would-be customers in Hawaii who were still unable to buy insurance policies online Wednesday, forcing them to turn directly to insurance companies to examine their options. In Oregon, officials said a faulty online calculator would not be fixed until late October.

The delays that continued Wednesday offered one good sign for President Barack Obama and supporters of his signature domestic policy achievement, demonstrating what appeared to be exceptionally high interest in the new system. But the problems also could dampen enthusiasm for the law as Republicans use it as a rallying cry to keep most of the federal government closed.

"It's day two of health care reform, and we have yet to have someone successfully register on the marketplace," said Matt Hadzick, manager of a Highmark retail insurance store in Allentown, Pa., where people could go to register for the online insurance marketplace. "The registration process is very slow, and at one point it just shuts down."

The sweeping changes under the Affordable Care Act include federal subsidies to make insurance more affordable for low-income consumers and preventing health insurance companies from denying coverage to people with pre-existing conditions. That will open the door for coverage to many people who have been locked out of the insurance market.

In California, home to 15 percent of the nation's uninsured, officials took down the enrollment portion of the Covered California website for emergency upgrades. It was restored at mid-morning Wednesday, and 7,770 people had started applications by then, spokesman Roy Kennedy said.

California is one of a handful of mostly Democratic states that opted to set up their own exchanges rather than let the federal government do it for them. In the 36 states being operated by the federal Department of Health and Human Services, consumer patience was being tested.

Agency spokeswoman Joanne Peters said many Americans successfully enrolled on the first day, but she declined to put a number on it. She said the delays were due to "overwhelming interest" and high volume.

The delays come three months after the congressional Government Accountability Office said a smooth and timely rollout could not be guaranteed because the online system was not fully completed or tested.

The bumpy debut has the hallmarks of a technology project that may have rushed to meet the Oct. 1 deadline, said Bill Curtis, chief scientist at CAST, a software quality analysis firm, and director of the Consortium for IT Software Quality, which develops standards.

"It almost reminded me of going online and trying to buy Springsteen tickets," said Sharon Schorr of suburban Cleveland, a self-employed accountant who finally gave up after eight hours of trying to use the exchange's website.

With websites crashing, those who have been trained to explain the benefits under the federal law were trying to reach out to those who could be helped by the exchanges, handing out information at public transit hubs and holding town hall meetings in smaller communities.

Without online access, however, they could not actually guide people through the enrollment process.

"I've been unable to get in, and if I could have that would be great," said Donene Feist, an outreach worker who also is executive director of Family Voices of North Dakota, a nonprofit advocacy group. "For those who got in, they said it was easy to follow."

The Obama administration hopes to sign up 7 million people in the first year, and eventually cover at least half of the nearly 50 million uninsured Americans through government-subsidized plans and a Medicaid expansion.

Many states expect people to sign up closer to the Dec. 15 deadline to enroll for coverage starting Jan. 1. Customers have until the end of March to sign up to avoid tax penalties.

___ Alonso-Zaldivar reported from Washington, D.C.

___ Contributing to this report were Associated Press writers Jeff Barnard in Grants Pass, Ore., Oskar Garcia in Honolulu; James MacPherson in Bismarck, N.D.; Laura Olson in Sacramento; Michael Rubinkam in Allentown, Pa.; and John Seewer in Toledo, Ohio.
Thursday, 03 October 2013 06:27
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   The online health insurance exchanges are now open in both Missouri and Illinois.  The online marketplace is a key component of the federal health care law.  

   Illinois officials have set up their own marketplace at GetCoveredIllinois.gov.  

   Missouri voters chose to bar their government from setting up its own marketplace.  So the federal government is running the exchange for Missouri residents at Healthcare.gov.

   Consumers have until December 15th to sign up if they want coverage to start on January 1, but enrollment is open until March 31.  

 

Tuesday, 01 October 2013 03:36
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