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Some anticonvulsants used to treat epilepsy and other conditions may increase the risk of suicide, attempted suicide or violent death, a new study finds.

While these drugs are used primarily to control epileptic seizures, they are also approved treatments for other conditions, such as bipolar disorder, mania, migraine and chronic nerve pain.

“Anticonvulsant medications have important therapeutic benefits, but they also have associated risks that both provider and patient need to remain aware of,” said study author Dr. Elisabetta Patorno, a research fellow at Brigham and Women’s Hospital and Harvard Medical School in Boston.

“Physicians should discuss associated risks and benefits with their patients, and together determine the best treatment course for the underlying medical condition,” she said. “Both patients and health-care professionals should be alert to early symptoms that might potentially be associated with suicidal risk.”

The report is published in the April 14 issue of the Journal of the American Medical Association.

For the study, Patorno’s group used the HealthCore Integrated Research Database, which has data on prescriptions and adverse side effects. Specifically, they looked at almost 300,000 patients aged 15 and older in 14 states who started taking anticonvulsant medications between July 2001 and December 2006.

During that period, the researchers identified 801 attempted suicides, 26 completed suicides and 41 violent deaths — 868 combined suicidal acts or violent deaths.

Patorno’s group found an increased risk of suicidal acts among patients taking the anticonvulsants gabapentin (Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal), tiagabine (Gabitril) and valproate, compared with people taking the anticonvulsant topiramate (Topamax).

In 2008, the U.S. Food and Drug Administration instructed manufacturers of anticonvulsants to include a label warning about the increased risk of suicidal thoughts or actions associated with these drugs.

“I do not think that the results should affect physician behavior at this time,” said Dr. Orrin Devinsky, director of the Epilepsy Center at NYU Langone Medical Center.

“Anti-epileptic drugs are used primarily in patients with epilepsy and patients with psychiatric disorders; both groups have well-known increased risk for suicidal behavior,” Devinsky said.

This study found the probability of suicidal acts after starting topiramate were relatively low compared to four other anticonvulsant medications, he said.

“The question is if there was a bias with regards to patients selected on these medications, and also whether these results, which were statistically significant, would be replicated and have clinical significance,” Devinsky said.

“It is possible that a new cohort would reveal a different profile, reflecting the random nature of the patient population and a selection bias of how doctors prescribe drugs,” he added.

Dr. Ewald Horwath, a professor of psychiatry & behavioral sciences at the University of Miami Miller School of Medicine, said the study may be misleading.

“The study did not take adequate account of why people were taking the anticonvulsant,” Horwath said. The authors noted that many of the people in the study were taking these drugs to treat bipolar disorder and depression, “conditions that are associated with higher suicide rates,” he said.

Horwath noted that another study of patients with bipolar disorder found these drugs actually decreased the risk for suicide.

SOURCES: Elisabetta Patorno, M.D., M.P.H., research fellow, Brigham and Women’s Hospital and Harvard Medical School, Boston; Orrin Devinsky, M.D., director, Epilepsy Center, NYU Langone Medical Center, and professor, neurology, neurosurgery and psychiatry, New York University School of Medicine, New York City; Ewald Horwath, M.D., professor, psychiatry & behavioral sciences, University of Miami Miller School of Medicine;

Critically ill patients in the intensive care unit may reduce their use of sedatives and speed their recovery by engaging in mild exercise, a new study has found.

The amount of prescription sedatives had to be slashed by half to enable patients to exercise, which reduced the amount of muscle weakness caused by spending long periods of time in bed, and shortened ICU recovery times by as much as two to three days, the researchers said.

Reduced use of sedatives in patients who exercised also led to fewer bouts of hallucination and delirium, according to the report published online April 9 in the journal Archives of Physical Medicine and Rehabilitation.

The study included 57 patients in the medical intensive care unit (MICU) at Johns Hopkins. The 30- to 45-minute exercise sessions were carefully guided by trained physical and occupational therapists and included any combination of either leg or arm movements while lying flat in bed, sitting up or standing, or walking slowly in the ICU corridors.

Some of the patients who did the exercises were attached to life support equipment, such as mechanical ventilators, the study authors noted.

The use of drowsiness-inducing benzodiazepines dropped to only 26 percent of patient days in the MICU in the four months after the start of the exercise program, compared to 50 percent of patient days in the three months before the start of the program.

Daily doses declined still further. Before early exercise was introduced in the MICU, half of the patients received more than 47 milligrams of midazolam and 71 milligrams of morphine per day, compared with less than 15 milligrams of midazolam and 24 milligrams of morphine after the exercise program began.

There was also a significant decline in patient delirium, which can include hallucination or being unaware of one’s surroundings. The number of clear-thinking days among patients increased from 21 percent to 53 percent after they began exercising, the study found.

“Our work challenges physicians to rethink how they treat critically ill patients and shows the downstream benefits of early mobilization exercises,” project leader and critical care specialist Dr. Dale Needham said in a Hopkins news release.

“Our patients keep telling us that they do not want to be confined to their beds, they want to be awake, alert and moving, and engaged participants in their recovery,” said Needham, an associate professor at the Johns Hopkins University School of Medicine. “Patients are not afraid of exercising while they are in the ICU, and they are embracing this new approach to their care in the ICU. It actually motivates them to get well and reminds them that they have a life outside the four walls surrounding their hospital beds.”

SOURCE: Johns Hopkins

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

Today’s approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need these products. Approved pancreatic enzyme products meet FDA standards for safety, efficacy, and product quality.

“The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them,” said Donna Griebel, M.D., director of the FDA’s Division of Gastroenterology Products.

Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Supplies of approved PEPs are expected to meet demand.

Currently, the FDA is working with approved PEPs manufacturers, patient advocacy groups, and health care professional organizations to make the public aware of the availability of pancreatic enzyme products. Patients with questions about their current PEP or making a switch to a different pancreatic enzyme product should consult with their healthcare provider.

Air pollution from high-traffic roads increases the risk of asthma in children who attend nearby schools, new research suggests.

In a study that looked at statistics on children’s health in Southern California communities, researchers found that those who attend schools near high-traffic areas are 45 percent more likely to develop asthma, although the number of students in the study who developed asthma was small.

“Exposure to pollution at locations other than home, especially where children spend a large portion of their day and may engage in physical activity, appears to influence asthma risk,” Dr. Rob McConnell, professor of preventive medicine at the Keck School of Medicine of the University of Southern California and lead author of a new study, said in a university news release.

The researchers examined a previous study of kindergartners and first-grade students who initially didn’t have asthma. In that study, researchers followed-up with the children for three years and examined traffic around their schools and homes. The investigators also monitored air pollution levels around the 13 communities that were studied.

Of the 2,497 students, 120 developed asthma.

“It’s important to understand how these micro-environments where children spent a lot of their time outside of the home are impacting their health,” McConnell said. “Policies that reduce exposure to high-traffic environments may help to prevent this disease.”

The study was recently published in the journal Environmental Health Perspectives.

Most people will welcome the start of daylight savings time this Sunday because it starts to stay light longer, even if that means the early mornings will be dark once again.

However, that shift may not be such a welcome change for people with seasonal affective disorder (SAD), a seasonal depression that occurs in the fall and winter and is caused, at least in part, by the lack of daylight during these seasons. Some experts suspect that light in the morning may be especially important for helping people with SAD, as well as for jumpstarting circadian rhythms in all people.

“In general, in terms of normal sleep patterns, daylight in the morning is better than light later in the day. Remember, our circadian rhythms were set eons ago to a rhythm that didn’t include daylight savings time, so the shift tends to throw people off a bit,” said Dr. Nicholas Rummo, director of the Center for Sleep Medicine at Northern Westchester Hospital in Mt. Kisco, N.Y.

“Daylight savings time is anti-physiologic, and it’s a little deleterious, at least for several days,” he said, adding that research has shown that the rate of auto accidents goes up slightly in the days following the change to daylight savings time.

For people with SAD, he noted, the shift in daylight may be even more difficult. “Normally, people with SAD start to feel better around this time of the year, and light earlier in the day is more helpful for them,” said Rummo.

Seasonal affective disorder is a type of depression that appears during the colder months of the year, and symptoms tend to be at their worst in January and February, according to the American Psychiatric Association. Symptoms of SAD include fatigue, a lack of interest in usual activities, social withdrawal, weight gain and a craving for foods high in carbohydrates, according to the association.

“The hallmark of seasonal affective disorder is a pattern of depression that occurs in the fall and winter months that improves in the spring. There’s a definite seasonal pattern,” explained Dr. Emil Coccaro, the E.C. Manning professor and chairman of the department of psychiatry and behavioral neuroscience at the University of Chicago. “They have a major depression in the fall and winter when there’s less light and they recover when there’s more and more light.”

The main treatment for SAD is exposure to bright lights, he said. And, during the fall and winter, people with SAD do this using light boxes that flood extra light into an area.

Previous research, reported in the Proceedings of the National Academies of Sciences, has suggested that bright light treatment is most effective when done in the morning for people with SAD.

Rummo said that people on the Western edges of a time zone, and those living in Northern areas, may be affected a little bit more because they already experience more darkness in the morning.

“This is something that people should be a little bit aware of,” said Rummo. But, he noted, it’s also important to remember that it is just an hour, and everyone, including people with SAD, will eventually adjust to the switch.

And, Coccaro added that for people with SAD, the amount of light you’re exposed to during the day is likely more important than the timing of that light exposure.

SOURCES: Nicholas Rummo, M.D., sleep specialist and director, Center for Sleep Medicine, Northern Westchester Hospital, Mt. Kisco, N.Y.; Emil Coccaro, M.D., E.C. Manning Professor, and chairman, department of psychiatry and behavioral neuroscience, University of Chicago

Hopes that two available drugs could help prevent diabetes and the problems it causes in overweight people with poor sugar metabolism have been dashed by a major international study.

The trial involved two drugs prescribed for other reasons — Diovan (valsartan), a blood pressure medication; and Starlix (nateglinide), which is given to control existing type 2 diabetes.

The study was financed by Novartis, the drug company that markets both products.

The Starlix portion of the five-year trial, involving more than 9,300 overweight adults, found the drug had no benefit in reducing the incidence of newly diagnosed diabetes, cardiovascular death or events such as heart attack, stroke and heart failure.

The Diovan portion did find a modest effect — 14 percent — in preventing new diabetes cases. However, as was the case in the Starlix part of the trial, using Diovan led to no reduction in the cardiovascular conditions for which diabetes is a major risk factor.

Results of the trial were reported in two papers released early on March 13 by the New England Journal of Medicine, and slated for presentation Sunday at the American College of Cardiology’s annual meeting, in Atlanta.

“It would be great if we had something that would prevent diabetes and cardiovascular disease at the same time,” said Dr. Robert M. Califf, vice chancellor for clinical research at Duke University, and one of the leaders of the trial. “We didn’t get that.”

And despite the faintly positive results of the Diovan portion of the trial, “in neither case would we recommend such prophylactive [preventive] treatment in people who don’t have diabetes but have abnormal glucose tolerance,” Califf said.

So, lifestyle remains the key factor in preventing obesity and poor blood sugar control from turning into full-blown type 2 diabetes, he said.

“It looks like diet and exercise are the mainstays of prevention,” he said. “If people could lose a few pounds more and exercise more, there would be a lot less diabetes.”

It’s an old message, but one that is difficult to get across, said Califf, who noted that more than 35 percent of the people in the trial did go on to develop diabetes in just five years. “We need to keep looking for better treatments, but lifestyle modification is the best thing we have going,” he said.

The people in the trial, which was done at 806 centers across 40 countries, had diagnosed cardiovascular disease, known risk factors such as obesity and impaired ability to metabolize sugar.

They were divided into groups — some receiving Diovan, some getting Starlix, and some taking a placebo. All entered a lifestyle modification program aimed at reducing weight and dietary fat intake and increasing physical activity.

Over five years, 36 percent of those taking Starlix developed diabetes, compared to 34 percent of those taking a placebo. Diabetes developed in about a third of those taking Diovan, compared to about 37 percent of those taking a placebo. The rates of cardiovascular problems and deaths were similar in all groups.

“We must continue to develop new therapies while encouraging people to exercise and pay attention to what they eat,” Dr. John McMurray, professor of cardiology at the University of Glasgow in Scotland and a member of the trial’s executive board, said in a Duke University news release. “Losing at little as 5 percent of body weight has been shown to make a dramatic difference in other studies.”

Diabetes is a growing world-wide medical problem, McMurray and Califf noted. Some 150 million people now have the disease — 90 percent have type 2 diabetes — and the incidence is predicted to increase 50 percent by 2025.

There is an inexpensive drug available that has been shown to help prevent diabetes, added Dr. David M. Nathan, a professor of medicine at Harvard University and director of the Diabetes Research Center at Massachusetts General Hospital, who wrote an accompanying editorial in the New England Journal of Medicine. It is metformin, a leading drug for diabetes treatment that has been used for decades.

A study he led reported in 2002 that metformin reduced new diagnoses of diabetes by 58 percent over three years and by 34 percent over 10 years, Nathan wrote. But lifestyle changes, such as eating less and exercising more, are equally effective preventive measures, he said.

SOURCES: Robert M. Califf, vice chancellor for clinical research, Duke University, Durham, N.C.; March 13, 2010, news release, Duke University; early online release, New England Journal of Medicine, and presentation, annual meeting, American College of Cardiology, Atlanta

Years ago, a popular cigarette advertising campaign proudly proclaimed to women, “You’ve come a long way, baby!”

But a recent study of teens shows the war on cigarette advertising that targets teens, especially teenage girls, might still have a ways to go.

Although the 1998 settlement agreement between big tobacco and state governments restricted advertising to children and teens, nearly half of teenage girls participating in the study could name their favorite cigarette ad. What’s more, the study found that teenagers who could name a favorite cigarette ad were 50 percent more likely to have smoked during the five-year study period.

One ad campaign in particular stood out in the minds of teen girls and increased their awareness of cigarette advertising, the study found. The product was Camel No. 9 cigarettes, and the ads featured a pink camel and a sub-brand of cigarettes called Stiletto. In addition to the very feminine ads placed in such magazines as Glamour and Vogue, the campaign also featured promotional giveaways, including flavored lip balm, purses and cell phone jewelry.

“These are the same people that brought us Joe Camel, a very big campaign with multiple different components,” said study author John Pierce, a professor of family and preventive medicine and director of the Cancer Prevention and Control Program at the Moores Cancer Center at the University of California, San Diego. “Now it seems like what they’re doing is trying a campaign, and then when people complain, they change and do something else.”

R.J. Reynolds, which makes Camel No. 9, said that the product and the advertisements were not designed to attract teenagers. “Camel No. 9 was developed in response to female adult smokers, both of Camel and competitive brands, who were asking for a product that better reflected their taste preferences and style,” according to a prepared statement issued by the tobacco company.

“When Camel No. 9 was launched in 2007, all magazine advertisements for it appeared in publications whose readership was at least 85 percent age 18 or older,” the statement continued. “More importantly, R.J. Reynolds has not run any print advertising for cigarettes, including Camel No. 9, for more than two years, and there has been no in-store advertising for Camel No. 9 since 2008.”

The study, published online March 15 in the journal Pediatrics, includes data from the fifth telephone survey of a nationally representative sample of teenagers that was designed to assess whether cigarette ads run after the tobacco settlement had any effect on adolescents.

The first survey was done in 2003 when the 1,036 children were 10 to 13 years old. The fifth survey was done in 2008.

The researchers found that, for boys, the proportion who had a favorite cigarette ad remained stable throughout the five surveys. For girls, however, there was a marked difference in the last study.

During the first four surveys, the number of girls who could identify a favorite tobacco ad remained about the same. But, during the last survey, which was conducted after the start of the Camel No. 9 campaign, the proportion of girls who had a favorite ad jumped by 10 percentage points, to 44 percent. The Camel brand was responsible for most of that increase, according to the study.

During the first four surveys, 10 percent to 13 percent of the girls said that Camel was their favorite ad. In the fifth survey, the number rose to 21.5 percent, the study reported.

“This article presents credible evidence that the Camel No. 9 cigarette advertising campaign has targeted underaged girls,” the researchers wrote.

Targeted advertising, Pierce said, can be very hard for parents to counter. “Parents can try to focus on the issue and pay attention to it, but sometimes the adult admonishing something can be a green light for a teenager,” he said. “Unfortunately, we don’t have easy prevention strategies for parents to use.”

He said that the American Legacy Foundation, a nonprofit anti-tobacco organization set up as a result of the tobacco settlement agreement, is working on ads that use social networking sites to try to counter some of the allure of tobacco among teenagers.

SOURCES: John P. Pierce, Ph.D., professor, family and preventive medicine, and director, Cancer Prevention and Control Program, Moores Cancer Center, University of California, San Diego; statement, R.J. Reynolds Tobacco Company, Winston-Salem, N.C.

Stem cells may one day be a viable treatment for people suffering from severe asthma, researchers say.

A new study published online in the March 15-19 early edition of the Proceedings of the National Academy of Sciences borrowed its idea from the field of organ transplantation, where multipotent stem cells in the form of bone marrow transplants are already used to reduce the risk of rejection in patients who have received donated organs.

Senior study author Dr. Eva Mezey, head of the adult stem cell unit at the National Institute of Dental and Craniofacial Research (NIDCR), cautioned that this was an early-stage experiment conducted only in mice, and humans shouldn’t get too excited just yet.

“On the one hand, people should be cautious that it might not be just as good in people. However, there are many human studies that have proven that these cells are able to modulate the immune system and tip the balance back to normal when the balance is gone,” she said. “It’s very likely that the intervention would work in humans.”

But clinical trials will depend on working out numerous details, including how the therapy would be delivered. In the mice, the stem cells were injected but aerosol administration might work better in humans, producing a more local result instead of systemic effects and, probably, fewer side effects, she noted.

And this stem cell therapy, if it ever reaches patients, is likely to be reserved for those who haven’t responded to other therapies. “Basically, you would think of this therapy in cases where patients are resistant to existing treatment,” Mezey explained.

Some 16 million people in the United States have asthma, and the incidence seems to be on the rise.

Because bone marrow transplants quell immune responses in transplant patients, the idea was that it might be beneficial in individuals with other immune-based diseases such as asthma.

Here, the investigators used mice that had been engineered to be allergic to ragweed and injected them with multipotent stem cells known as bone marrow stromal cells. Multipotent stem cells are cells that can develop into many different cell types.

Indeed, animals injected with the compound had fewer allergy and asthma symptoms when exposed to the allergen, ragweed.

“We gave the mice intravenous injections of stem cells and, after four days, we assessed different mediators of the inflammatory response and that’s how we could pick up the beneficial effects of the stem cells,” said study first author Dr. Krisztian Nemeth, a research fellow with the adult stem cell unit of NIDCR.

After that, he added, “we went into more accurate details and tried to explore what anti-inflammatory molecules were synthesized by our cells and how they mediated the anti-inflammatory response.”

It turned out that the stem cells righted the balance of certain white blood cells that are out of sync in those with asthma.

SOURCES: Eva Mezey, M.D., Ph.D., head, adult stem cell unit, National Institute of Dental and Craniofacial Research (NIDCR); Krisztian Nemeth, M.D., Ph.D., research fellow, adult stem cell unit, NIDCR;  Proceedings of the National Academy of Sciences, online

A serious bout with a tummy bug may mean heartburn years later, new research shows.

Serious bacterial or viral infections of the digestive system-known medically as infectious gastroenteritis-may lead to some cases of irritable bowel syndrome, possibly by causing low-grade inflammation in the intestine, Dr. Alex Ford of McMaster University Medical Center in Hamilton, Ontario and his colleagues note.

Studies have suggested that such infections could also be linked with functional dyspepsia-basically, symptoms of heartburn, fullness and indigestion with no known cause-but the evidence isn’t as strong.

To investigate, Ford and his team looked at a group of people who had been living in the small rural town of Walkerton, Ontario, during a 2000 outbreak of bacterial gastroenteritis after the municipal water supply became contaminated with cow manure. At least 2,300 people were sickened, and seven died.

Two years after the outbreak, in 2002, the researchers enrolled a representative sample of the town’s population in an ongoing study. In 2008, they followed up with 1,088 of the study participants, about two-thirds of whom reported having gotten sick during the outbreak. About 40 percent of the entire group reported dyspepsia symptoms, such as heartburn and unpleasant sensations of fullness after a meal.

Among those who’d been sickened in the outbreak, half had dyspepsia symptoms, compared to 30 percent of the people who hadn’t gotten sick during the outbreak. The risk was more than twice as high for the outbreak victims, and this remained true even when the researchers used a stricter definition for dyspepsia.

The findings suggest, the researchers conclude, that gut infections “have the ability to trigger symptoms that affect the upper, as well as the lower gastrointestinal tract, with long-lasting consequences.”

SOURCE: Gastroenterology.