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

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.