FDA study report

Anemia Drugs Linked to Stroke Study Deaths: FDA


Preliminary results from a German study suggest that stroke patients' use of anti-anemia drugs such as Aranesp, Procrit and Epogen might end up boosting their risk for death, the U.S. Food and Drug Administration (FDA) warned on Friday.

The goal of the study was to see if high doses of the anti-anemia drug epoetin alfa could improve the ability of stroke patients to take care of themselves after recovering from a stroke.

The hope was that the drug would be neuroprotective, but use of epoetin alfa now appears linked to a near-doubling of mortality.

This is not the first time that these drugs have come under scrutiny. In the United States, medications like Procrit were marketed heavily as anemia treatments, particularly for cancer patients and those with kidney failure.

However, in July of this year, the FDA called on manufacturers of Aranesp and Procrit to add a warning label that could limit their use for cancer patients.

These changes were spurred by studies that showed these types of medications might cause tumors to spread and also raise patients' risks for bleeding. These findings resulted in an FDA advisory committee recommending in June that while the drugs should remain on the market, they should not be used in patients whose cancer is curable.

The committee also voted to recommend against the drugs' use in patients with breast or head and neck cancer.

The new German study looked at the use of epoetin alfa as an aid to stroke recovery.

"These drugs are not licensed in the United States for this particular use," noted Dr. Kathy Robie-Suh, a team leader in the division of medical imaging and hematology at the Center for Drug Evaluation and Research, part of the FDA's Office of New Drugs and Office of Drug Safety.

"The drug has been approved for about 19 years for treating anemia in patients with acute renal [kidney] failure and in other settings," Robie-Suh said. "Today's warning doesn't have any bearing on the particular label uses of the product in the United States," she said.

The FDA will continue to look into the results of this study, Robie-Suh said. "We have asked for more information about the study. We would certainly like to receive the data, but those data are not in our hands or under our control," she said.

For the trial, 522 stroke patients were randomly assigned to receive relatively high doses of epoetin alfa or a placebo. Some patients were also given R-tPA, a powerful clot-busting drug.

Three months after the start of the trial, 16 percent of the patients who received high doses of the drug epoetin alfa died, compared with 9 percent of patients who were not given the drug, according to the U.S. Food and Drug Administration (FDA).

Among the deaths in the German trial, about 50 percent occurred within the first week after the drug was started. Among those receiving the drug, 4 percent died from bleeding within the brain compared with 1 percent of the patients who were not given the drug.

The FDA said that it expects to receive more data on the study "within the next several weeks," and when the agency's analysis is complete, it will "communicate our conclusions and recommendations to the public."

Friday's FDA notice was issued after Ortho Biotech -- the division of the pharmaceutical giant Johnson and Johnson, which makes Procrit -- alerted the agency to the results of the German trial.

"Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke," the company said in a Sept. 17 statement. "Ortho Biotech has reported this information to the U.S. Food and Drug Administration and to European regulatory authorities. Additional analyses are under way to better understand these preliminary results."

"This study is interesting, because people were looking at potential neuroprotective effects of erythropoiesis-stimulating agents (ESAs)," said Dr. Samuel M. Silver, a spokesman for the American Society of Hematology.

These patients were not anemic, Silver noted. "They were also receiving very powerful clot-busting drugs at the same time as relatively high doses of ESAs. These are not the typical patients in any way shape or form that usually receive these drugs," he said.

Silver doesn't think further action by the FDA is needed. "I don't think the drug needs to be looked at for patients who are currently being treated in this country, but it certainly will give pause to the way studies are being designed to look at the neuroprotective effects of these drugs," he said

Dad's in-home smoking may harm family's health

Fathers-to-be who smoke and want to protect the health of their families should take it outside, suggests new research from Korea.

Newborns whose fathers had smoked in the home had higher levels of nicotine in their hair than babies born to non-smoking dads, Dr. Moon-Woo Seong of the National Center in Goyang and colleagues found. But infants whose fathers smoked, but only did so outdoors, had no more nicotine in their hair than babies whose fathers did not smoke at all.

"Outside smoking substantially reduces maternal and fetal exposure," they conclude.

The study, reported in the latest issue of the American Journal of Epidemiology, included 63 mother-father-newborn trios. None of the mothers in the study were smokers, or were regularly exposed to second-hand smoke outside the home. In 27 families neither parent smoked, fathers only smoked outdoors in 27 of the families, and in 9 families the father smoked indoors.

Mothers living with smokers had significantly more nicotine and its byproduct cotinine in their hair, Seong and colleagues found, but there were no significant difference between nicotine and cotinine levels in the hair of babies with non-smoking fathers and those with smoking fathers.

However, when the researchers looked separately at indoor and outdoor smoking, they did find higher nicotine levels in the children of indoor smokers compared to outdoor smokers.

Based on average nicotine levels, note the researchers, the wife of an indoor smoker is exposed to 7.4 percent of all of the smoke her husband consumes, while 16.7 percent of the smoke a mother inhales is passed to her fetus.

"Our findings," the team concludes, "indicate that paternal smoking inside the home leads to significant fetal and maternal exposure to environmental tobacco smoke. We also found that paternal smoking outside the home helpfully reduces levels of environmental tobacco smoke to which the smoker's wife and her fetus are exposed."

Craving Chocolate? Take a Walk Instead

Craving Chocolate? Take a Walk Instead
Study Shows a Brisk Walk May Help Curb Chocolate Cravings


Chocolate has a special allure for many of us, bordering on the addictive. But a new study shows that taking a brisk walk can cut down the urge to eat chocolate -- and may help curb cravings that can derail weight loss efforts.

When it comes to cravings, chocolate is the most common and "intensely" craved food, according to background information presented with the study findings.

Researchers wanted to look at what goes into an intense craving and how one might break it.

Adrian Taylor and Anita Oliver of the University of Exeter gathered 25 people whom they describe as "regular chocolate eaters" -- those who ate at least two 50-gram bars of chocolate a day.

The chocolate-eaters were deprived of their favorite sweet for three days; they were also told not to exercise or have caffeine for two hours before the test period. Abstaining from chocolate, being under stress, and then exposing someone to chocolate has been shown to ignite cravings for chocolate.

Blood pressure and heart rate were monitored; participants also completed a food-craving questionnaire.

On separate days, one group of participants took a brisk 15-minute walk on a treadmill. They were told to walk as if they were catching a bus, but not until they were out of breath. The comparison group sat quietly for 15 minutes.

After walking or doing nothing, each participant took a computerized test (the stressor) and unwrapped and handled a chocolate bar -- but they were not allowed to eat it.

Researchers found that the group that exercised had a significant reduction in chocolate cravings when compared to their baseline.

Taking a brisk walk also eased blood pressure readings for participants after the mental-challenge test and handling the unwrapped chocolate. Being sedentary did not appear to lessen cravings.

Facts About Food Cravings

In their study, the researchers also provided this background information about food cravings:
Up to 97% of women and 68% of men experience food cravings.
Cravings are usually for dense, calorie-packed foods.
Food cravings often come before a bout of unhealthy eating.

In an introduction to the study, the researchers write that food cravings have been known to be responsible for throwing people off track when they are in treatment programs to lose weight or to recover from an eating disorder.

The researchers hope the findings can help shed light on how to interrupt cravings, since past research has shown that even tiny changes in how much people eat and small increases in exercise can be helpful in keeping weight off and creating good health habits.

The study appears in the latest issue of the journal Appetite.

MP3 Player Headphones May Throw Off Cardiac Devices

Study found they could cause interference when placed too closely to pacemakers, ICDs

Tucking the headphones for your iPod into your coat pocket might not be exactly heart-stopping, but it could interfere with the normal functioning of your implanted cardiac device.

Harvard researchers presenting Sunday at the American Heart Association's annual scientific sessions, in New Orleans, report that magnets in these headphones might throw off pacemakers and implantable cardioverter defibrillators (ICDs) when placed within an inch of the devices.

Although interference is unlikely to cause life-threatening problems, the authors of the study advise those with ICDs and pacemakers to keep headphones at least 1.2 inches from their device.

Others agreed.

"Don't put the device near your torso," recommended Dr. Peter Cheung, an assistant professor of internal medicine at Texas A&M Health Science Center College of Medicine and a cardiologist with Scott & White Hospital. "Instead of your breast pocket, put it in your pants pocket or purse, and don't let the speakers hang from your shoulder or neck."

"People need to take just as much care with their MP3 as much as they do with other sources of electromagnetic interference," said Dr. Daniel Morin, a staff electrophysiologist with Ochsner Health System in New Orleans.

Other possible interference can come from microwaves, theft detection devices in malls and stores, and other sources, but patients should be fine with routine use. "Just don't hug the microwave," Morin said.

Previous research has indicated that iPods have little, if any, effect on pacemakers and ICDs, and a statement from the U.S. Food and Drug Administration confirmed that interactions between MP3 players and implanted devices are unlikely.

But less attention has been placed on headphones.

The authors of this latest study tested eight different types of MP3 headphones with iPods on 60 patients with defibrillators or pacemakers.

The headphones were placed on patients' chests right over their devices. Fifteen percent of patients with pacemakers and 30 percent of those with defibrillators had a response to the magnets.

But even higher-strength magnets had no effect when kept at least 1.2 inches above the device location.

"It's good information, but I don't think it's going to be a big deal," said Dr. Spencer Rosero, an associate professor of medicine in the electrophysiology unit at the University of Rochester Medical Center. "In very unusual circumstances, it can interfere, but the situation has to be just right, which doesn't really apply for daily living. . . It would not kill you."

And even a front shirt or jacket pocket is unlikely to be right above a pacemaker or defibrillator, he added. "Pacemakers are usually two-to-three fingerbreadths below the collar bone. Most pockets are not that high," Rosero said.

Two other studies being presented at the heart meeting also absolved other devices from interfering with pacemakers and ICDs.

According to one set of researchers from Massachusetts, Bluetooth cell phone technology, and capsules equipped with tiny cameras that are swallowed to view internal organs, did not interfere with the devices.

And another group of researchers from California found that electric blankets and hand-held airport security metal detectors, in addition to iPods, iPhones and Bluetooth, did not affect pacemakers or ICDs.

Quit Caffeine While Pregnant

Women who plan to become pregnant should quit caffeine completely -- or at least "markedly reduce" caffeine consumption -- when pregnant, British researchers report.

That advice may "unnecessarily frighten some women," states an editorial published with the study in BMJ, formerly called the British Medical Journal.

But the researchers and editorialists agree that cutting back on caffeine during pregnancy seems like good advice.

The debate springs from a new study of 2,600 women who gave birth at two British hospitals between 2003 and 2006.

Every trimester while pregnant, the women reported their consumption of caffeinated products including tea, coffee, soft drinks, energy drinks, and chocolate. And in their first trimester, they recalled their consumption of those items in the month before conception.

The researchers focused on fetal growth restriction -- babies born smaller than expected for their gestational age -- and a potential link to caffeine consumption.
Caffeine During Pregnancy

Relatively few women in the study -- 13% -- had a baby with fetal growth restriction. Greater caffeine consumption was linked to greater odds of having a baby with fetal growth restriction.

For instance, compared to women who got less than 100 milligrams per day of caffeine, the odds of having a baby with fetal growth restriction were:
20% higher for women who got 100-199 milligrams per day of caffeine
50% higher for women who got 200-299 milligrams per day of caffeine
40% higher for women who got more than 300 milligrams per day of caffeine

For comparison, a standard 8-ounce cup of drip coffee has 85 milligrams of caffeine.

The researchers -- who included Justin Konje, MD, of England's University of Leicester -- calculated those estimates after considering the women's alcohol and tobacco use.

The findings don't prove that caffeine was to blame for fetal growth restriction. But Konje and colleagues point out that caffeine can cross the placenta, passing from mother to fetus.

The issue might not be caffeine itself, but one of the compounds that caffeine breaks down into, Konje's team speculates.
Caffeine During Pregnancy: Second Opinion

Not all studies on the topic have tied caffeine consumption to increased risk of fetal growth restriction, so an editorial published with the study stops short of telling pregnant women to quit caffeine.

"We think that this advice is not justified by the current body of evidence, and that such advice may unnecessarily frighten women who have consumed caffeine while pregnant," write the editorialists, who included Professor Jorn Olsen, MD, PhD, of the University of California, Los Angeles School of Public Health.

But Olsen's team isn't dismissing the potential risk.

"We ... think that pregnant women should be advised to reduce their intake of caffeine products during pregnancy," as long as they don't replace those products with alcoholic beverages or sugary soft drinks, Olsen and colleagues write.

Women at Higher Risk

 Women at Higher Risk for Pulmonary Hypertension
They are 4 times more apt to develop the lung artery disorder, study shows  

Women are four times more likely to develop a debilitating and potentially lethal lung disorder known as pulmonary hypertension, a new study shows.

Pulmonary hypertension is caused by high blood pressure in the arteries that supply the lungs with blood. People who suffer from the condition can become tired, dizzy and short of breath, because the arteries feeding the lungs constrict and reduce the supply of oxygenated blood being circulating throughout the body.

The new study was led by Dr. Adaani E. Frost from the Baylor College of Medicine in Houston. He and his colleagues compared data from the REVEAL registry, which includes more than 2,300 patients, against data from the U.S. National Institutes of Health, a French registry and another large U.S. registry from one medical center.

They found that, among people in the United States, pulmonary hypertension affects four times more women than men. It is also more likely to strike those aged 48 and older.

And although there is more awareness among doctors of pulmonary hypertension, the time frame from when symptoms first develop to diagnosis has actually increased by 10 months, Frost's team found.

"The huge REVEAL database clearly demonstrates changes in the pulmonary hypertension demographic characteristics since the original NIH registry, indicating older presentation and striking female preponderance. Diagnosis is not occurring earlier, in spite of increased awareness of the disease," the researchers conclude. "Efforts must be made to decrease delays between onset of symptoms and diagnosis of pulmonary hypertension."

The research was to be presented Wednesday at the American College of Chest Physicians annual meeting, in Philadelphia.