Saturday, December 29, 2012

Recall of More Hydrocodone-Acetaminophen Tablets

prescription pill bottles

Dec. 26, 2012 -- More lots of the combination painkiller hydrocodone-acetaminophen are being recalled by Mylan Institutional. The new alert follows a nationwide recall of 101 lots of the drugs issued by Qualitest Pharmaceuticals that occurred earlier this month.

The FDA says the newly recalled lots were manufactured by Qualitest Pharmaceuticals and were repackaged and distributed by Mylan Institutional. The three lots include:  

The recalled bottles are supposed to contain tablets made up of 10 milligrams of hydrocodone and 500 milligrams of acetaminophen. But they are being recalled because the tablets may contain higher amounts of acetaminophen or hydrocodone than indicated on the label.

High doses of acetaminophen may put you at increased risk for liver damage.

Especially at risk are people who:

Take other medications containing acetaminophenHave liver diseaseDrink more than three alcoholic beverages a day

Additionally, too-high doses of hydrocodone can cause increased sedation and/or breathing problems, particularly among the elderly, people with severe kidney or liver impairment, and those who are taking other sedating medications or certain antidepressants.

If you have the affected lots you can contact Mylan Customer Service at 800-848-0462. People who are unsure should call their pharmacist or doctor.


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Sinus Problems: Home Remedies and Tips

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By Kathleen Doheny

Reviewed By Michael W. Smith, MD

Are you among the 37 million Americans who have sinus problems each year? If so, there's a lot you can do around the house to create a "sinus-friendly" environment -- reducing your risk for sinus pressure.

Even better, many of the measures are simple and inexpensive.

Sinus Problems: Getting to the Triggers

First, it's crucial to figure out why you have sinus problems, says Jordan Josephson, MD, a Manhattan ear-nose-throat specialist and author of Sinus Relief Now.  "Allergies are a fairly common reason for sinus problems," he says.

Allergies that affect the nose, such as hay fever and indoor allergies, can cause the nasal membranes to swell, and the passages to the sinuses -- hollow spaces within the bones around the nose -- to become blocked. Mucus, which typically drains from the sinuses to the nose, can't drain.  

Other reasons? "A dry nose leads to more sinus problems," says Richard F. Lavi, MD, an allergist in Beachwood, Ohio.

Whatever the trigger, you can pick and choose from these five tips, or adopt all of them.

Sinus Tip 1: Keep Your Cool

"When the heat is on, the membranes get dry," says Russell B. Leftwich, MD, an allergist in Nashville, Tenn. Mucus isn't cleared as effectively, boosting the risk of sinus problems.

He can't recommend a specific indoor temperature range as ideal, but offers this guide: "You are better off wearing a sweater and keeping it cooler than cranking it up so you are comfortable wearing only a T-shirt."

Let your nose guide your indoor temperature range, suggests Lavi. "If you are not waking up with nosebleeds or congestion, that is probably a good temperature range."

Sinus Tip 2: Humidify Your Air

Strive for an indoor environment that's not too dry and not too humid.  "Dust mites love greater than 50% humidity," Lavi warns. And if you're allergic to dust mites, that's bad news for your sinuses.

A too-humid indoor environment can also encourage the growth of mold, which can also set off sinus problems, says Todd Kingdom, MD, director of rhinology and sinus surgery at National Jewish Health in Denver.

Experts are divided on the value of room humidifiers for creating a sinus-friendly home.

Forget them, Leftwich says. "A room humidifier never makes a difference. There is too much air to humidify."

But Josephson says using humidifiers in the bedroom beginning in October through March or April can make a difference in keeping sinus problems at bay.

Vaporizers can keep you more comfortable if you are in the midst of a sinus problem, Leftwich says. But you need to have it close by. "It doesn't do any good to have a vaporizer on the other side of the room." And, he warns, the devices must be cleaned daily to keep bacteria from growing in them.

Breathe the mist coming from vaporizers, but not the steam, he warns. Steam can easily burn you. Ten minutes at a time is often recommended.

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FDA Warns of Fatal Rash From Hep C Drug Incivek

By Cari Nierenberg
WebMD Health Newsprescription pill bottle

Dec. 19, 2012 -- The FDA warned people taking the hepatitis C drug Incivek (telaprevir) that it has received reports of a serious skin rash from the medication, which has led to several deaths.

The deaths occurred in people taking Incivek combination treatment. This antiviral treatment includes the drug Incivek in combination with the drugs peginterferon alfa and ribavirin.

This combination treatment is most commonly used for genotype 1 chronic hepatitis C in adults with compensated liver disease (meaning the liver has some damage but still works), including those who have cirrhosis (scarring of the liver) or those who have previously received interferon-based treatment.

The FDA says some people had developed a serious skin rash while on the combination drug treatment, yet they continued to take the three medications despite the rash worsening and leading to life-threatening symptoms.

The FDA advises people receiving Incivek combination treatment to be aware of the potential for developing a rash as a side effect of drug treatment. It recommends that anyone who gets a serious skin reaction after taking these drugs stop them immediately and seek emergency medical care.

The FDA will be adding a boxed warning about these potential problems to the Incivek drug label. The warning will instruct people receiving Incivek combination treatment to immediately discontinue all three medications if they develop a rash.

In a news release from Vertex Pharmaceuticals, makers of Incivek, the company said that less than 1% of people who received Incivek combination treatment had a serious skin reaction to it when the treatment was tested in a late-stage clinical trial. These patients required hospitalization for the skin reaction, yet all recovered from it.

The FDA also encourages patients and health care professionals to report any serious or harmful side effects to its MedWatch Safety Information and Adverse Event Reporting Program. This report can be submitted online. Forms can also be obtained by calling 800-332-1088, and then faxing to 800-FDA-0178. 


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Rates of Childhood Obesity Fall Slightly

children in huddle smiling

Dec. 25, 2012 -- New data suggest that we may have turned an important corner in the childhood obesity epidemic.

While rates of obesity and extreme obesity in preschoolers rose from 1998 to 2003, they began to plateau soon thereafter. And childhood obesity rates decreased slightly in 2010.

"We are very encouraged by this data," says study researcher Heidi M. Blanck, PhD, of the CDC in Atlanta. "It's pretty exciting and a nice turning of the tide. But we have to stay vigilant or it will go in the other direction."

Researchers looked at data on 27.5 million children aged 2 to 4 from 1998 to 2010. These children were from 30 states and Washington, D.C. Many were eligible for government assistance.

The rate of child obesity rose from 13.05% in 1998 to 15.21% in 2003. But it fell to 14.94% in 2010.

The rate of extreme child obesity declined from 2.22% in 2003 to 2.07% in 2010, the study shows.

The findings appear in the Journal of the American Medical Association.

What makes the data even more promising is that many of the national initiatives aimed at lowering rates of childhood obesity hadn't been started or were not at full force during most of the study period, Blanck says.

For example, efforts aimed at making it easier for new moms to breastfeed are just now gaining traction. Breastfeeding has been shown to help prevent obesity. There are also new programs that help people on food stamps purchase healthier foods.

There's also a lot that families can do in their own homes to encourage healthy lifestyles. These include getting more physical activity during the day and less screen time. "Walk the family dog together to get exercise," Blanck says.

Also, get rid of sugary drinks and beverages in the home, and make fruits and vegetables available. "We know that childhood obesity tracks into adulthood, so it's important to make these changes early and maintain them," she says.

"The news is definitely encouraging," says Leslie Lam, MD. He is a doctor at The Children's Hospital at Montefiore Medical Center in New York City.

William Muinos, MD, says the new findings have not trickled down to his patients yet. He is the associate director of pediatric gastroenterology at Miami Children's Hospital. "My childhood obesity clinic is growing in leaps and bounds," he says. "We can do a lot better."

Shari Barkin, MD, is also not sold on the fact that rates are declining yet. She is a professor of pediatrics at Vanderbilt University in Nashville, Tenn. "I'm heartened because we are holding our own," she says. "It is good news that we have stabilized, but these current rates, even stabilized, are unacceptable."

Her advice to families is to aim for 30 minutes a day of physical activity. "More is great, but we should all start here," she says. "The best way to get preschoolers active is to get the family involved. "Parents are the best teachers."

And make it fun. "We don't call it exercise, we call it play."


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How Do Sleeping Pills Really Work?

Study Says It's Partly Because You Think They Doman sleeping

Dec. 20, 2012 -- The most widely prescribed sleeping pills do help people get to sleep, but maybe not only because of the medicine, a new study suggests.

When researchers combined studies of some of the newer prescription sleep drugs, they concluded that the drugs owe about half their benefits to a placebo effect.

But at least one sleep expert disagrees with that conclusion.

The drugs included in the study were the sleep aids Ambien, Lunesta, and Sonata and their generic versions.

The researchers conclude that these drugs improved people's ability to fall asleep compared to a placebo; however, the size of the effect was small.

They add that the risk of side effects and the potential for addiction need to be weighed  when considering using these medications for treating insomnia.  

Side effects of sleeping pills can include memory loss, daytime sleepiness, and increased risk of falls, and researchers say the drugs may be especially risky for older patients.  

But a sleep specialist says the study does little to convince him that the drugs -- used by millions of people worldwide -- are less effective than studies suggest.

“The fact is that it is difficult to measure the effectiveness of sleep medications in studies. Patients take them and they either work or they don’t.”

“I don’t see how these researchers can come to the conclusion that 50% of the effect of these sleeping pills are due to the placebo effect,” says David Volpi, MD, of the sleep disorders division of Lenox Hill Hospital in New York.

The new analysis, published in BMJ, was a collaborative effort by scientists from the University of Lincoln in the U.K., Harvard University, and the University of Connecticut.

It included data from 13 trials submitted by pharmaceutical companies to the FDA for approval of eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien).

The studies focused on the time it took to fall asleep after taking the drug.

The new analysis shows that sleeping pill users fell asleep about 22 minutes faster than non-users. Those on placebo fell asleep after 42 minutes.

According to researcher A. Niroshan Siriwardena, MD, PhD, one of the major limitations of studies submitted to the FDA is that they failed to measure some of the most troubling issues associated with sleep disturbances including total sleep time, waking after falling asleep, and daytime sleepiness.

“Because the studies didn’t measure these things, we cannot say whether these drugs are useful for improving these outcomes,” he says.

Volpi says prescription sleeping pills are often used by patients for much longer than they were originally intended.

These drugs are overprescribed and patients stay on them too long, he says. “It’s not unusual to see patients who have been on them for years.”

Siriwardena and Volpi also agree that other types of sleep treatments, such as talk therapy, are underutilized and could be used to help many more patients with sleep issues.

“There are so many things you can try for sleep problems, and cognitive behavioral therapy is one of the best things patients can do to get off of these medication,” Volpi says says.

The manufacturer of Ambien was contacted but declined to comment. The makers of Lunesta and Sonata were contacted but did not respond before publication.


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Hiking in Nature May Boost Creativity

woman enjoying nature on hike

Dec. 12, 2012 -- Hiking in the wild may be good for the brain, especially if you are unplugged.

New research shows that backpackers scored 50% better on a creativity test after spending four days in nature while disconnected from all electronic devices.

Fifty-six people with an average age of 28 went on four- to six-day wilderness hiking trips organized by the Outward Bound expedition organization in Alaska, Colorado, Maine, and Washington. No phones, tablets, computers, or other electronic devices were allowed on the excursions.

Of these people, 24 took a 10-item creativity test the morning before the trip, and 32 took the test on the morning of the trip's fourth day. People who had been backpacking for four days got about six of the 10 questions correct, compared with four among people who had not yet begun a backpacking trip.

So is it the serene effects of nature that unlock creativity, or is it perhaps a perk of being unplugged?

Maybe a little bit of each, says researcher David Strayer, PhD. He is a professor of psychology at the University of Utah in Salt Lake City.

Still, the participants spent four full days in nature without any gadgets, which may not be possible for many people. But that doesn’t mean others can’t reap some of these benefits. 

“Take a stroll through the park if you can’t get away for longer,” he says. “If you could do that on a regular basis, you can reduce stress, and it may have mental or cognitive benefits as long as you disconnect from all technology.”

Listening to music can be OK provided it is soothing. “If you talk on your phone or text, you may not get as many benefits.”  

The findings appear online in the journal PLOS ONE.

James P. Nicolai, MD, is the medical director of the Andrew Weil, MD, Integrative Wellness Program at Miraval in Tucson, Ariz.  He says the new findings are “right on.”

Disconnecting from media technology allows people to stay in the now, and nature can do the rest, he says. “Take a 10- to 15-minute walk in a park five days a week,” he says.  Or “if you can’t get to nature, bring nature to you by having flowers in your house or plants in your space.”

That is good advice, says David Straker, DO. He is an adjunct assistant clinical professor of psychiatry at Columbia University Medical Center in New York City. “We know exercise is one of the most important things we can do for our mental health aside from medication and therapy.”

It helps release feel-good brain chemicals called endorphins, and nature kicks these benefits up a notch. “Exercising in nature can have more mental health benefits than on a treadmill,” he says.


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How Men Can Avoid Common Mistakes After Divorce

Reviewed by Kimball Johnson, MD

Adapting to life after divorce is hard for guys under the best of circumstances. But you can make it easier on yourself, your ex, and your children if you avoid some of the most common mistakes.

Too many men seek out a new relationship before the dust has settled on their divorce, says psychologist Sam J. Buser, PhD, coauthor of The Guys-Only Guide to Getting Over Divorce. They rush into new relationships -- and often into new marriages -- within the first year.

"That's no doubt the biggest mistake," says Buser, who is based in Houston.

Buser says that men often jump into dating because they're lonely, vulnerable, and sad, and they're looking for someone to help them feel better.

"The relationships they start do not often work out in the long run," he says. "I advise my patients to wait at least two years. I've never had a man take me up on that advice, but I do try to slow them down."

He also advises men to date casually at first.

"Tell the woman you've just been through a tough divorce and that you're not ready for a committed relationship," he suggests. "Acknowledge that it is not the right time for that."

After a divorce, it's easy for guys to let themselves become isolated, especially if the ex gets custody of the kids. That's another big mistake. It can worsen feelings of depression, guilt, and loneliness, a potentially dangerous mix. Divorced men are twice as likely to commit suicide as married men. 

Divorced men are also more prone to alcohol problems, so be careful of starting down that road. 

"You don't have to drink every day to have a problem," Buser says. "Drinking a six pack is a binge."

Buser's advice: Connect with other guys. Call up old friends, join a softball team, a club, or a professional association.

"Expand your social and professional network to avoid isolation."

He also says that the aftermath of a divorce is great time to go back to school. It keeps you active, stimulates your mind, potentially advances your career, and gets you out of the house.

You've met someone new. You're excited and happy. Good for you. Just don't make the mistake of expecting your kids to be upbeat about it.

"The last thing the kids want to see is parents getting involved with someone else," says Gordon E. Finley, PhD, a psychologist who specializes in issues facing divorced men and an emeritus professor of psychology at Florida International University in Miami. "They are going to be unhappy. Date when you feel ready, but leave the kids out of it."

Buser agrees. "Focus on the other adult when starting a relationship," he says. "She can meet the kids when you know you are serious."


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Does IQ Test Really Measure Intelligence?

intelligence quotient illustration

Dec. 20, 2012 -- Single tests that measure intelligence quotient, or IQ, may become a thing of the past.

A new study of more than 100,000 participants suggests that there may be at least three distinct components of intelligence. So you could not give a single, unified score for all of them.

Researchers' understanding of the complexities of the human brain has evolved, and so too has the notion of IQ, what it really means, and how it is most accurately captured.

“There are multiple types of intelligence,” says researcher Adam Hampshire, PhD. He is a psychologist at the Brain and Mind Institute Natural Sciences Centre in London, Ontario, Canada. “It is time to move on to using a more comprehensive set of tests that can measure separate scores for each type of intelligence.”

In the study, all participants were invited to take a series of 12 online tests that measure memory, reasoning, attention, and planning as well as information on the test takers' background and lifestyle. The entire test takes about 30 minutes to complete.

According to the findings, there are at least three components that affect overall performance on tests. These include short-term memory, reasoning, and verbal recall.

Lifestyle factors count, too. For example, gamers -- or people who play a lot of computer games -- score higher on tests of reasoning and short-term memory. Smokers do poorly on tests assessing short-term memory and vocabulary, while test takers who have anxiety don't do as well on short-term memory tests, the study shows.

What’s more, the study suggests that each type of intelligence may have its basis in a different set of brain areas. Researchers used sophisticated brain scans called functional MRIs to map out these areas.  “Potentially, we can measure a more comprehensive set of intelligences," each of which reflects the capacity of a different part of the brain, Hampshire says.

So should the IQ test that has provided bragging rights for so many be discontinued or discredited?

Not so fast, he says. “Some very valuable research has been carried out using classical IQ testing. However, IQ is a massive oversimplification of the spectrum of human cognitive ability.”

IQ scores may also be somewhat misleading, Hampshire says. “Based on the results of our study, it seems likely that IQ differences will vary in scale or even direction depending on the exact type of intelligence that the test or set of tests rely most heavily upon. I would suggest that it is both more accurate and informative to measure multiple types of intelligence.”

He plans to see if there are other types of intelligence that were not captured in this study.

Hampshire said the findings themselves weren’t all that surprising, but the number of people who took part in the study exceeded expectations. “I had thought a couple of thousand people might log in and participate in the study over the course of six months. Instead, tens of thousands logged in within the space of a few weeks,” he says. It was a remarkably strong response from members of the general public, who gave half an hour or more of their time to support this research.”


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