Blood Thinner May Have Caused Allergic Reactions in More Than 50 Dialysis Patients
Vials of the blood thinner heparin may be responsible for allergic reactions in 53 dialysis patients from 12 states.
The suspected batches of heparin were recalled by its manufacturer, Baxter Healthcare Corp. in January, the Associated Press reports, but many vials of the tainted drug were used before the recall was ordered.
The U.S. Centers for Disease Control and Prevention says on its Web site that the nine multi-vial recalled lots were all made at a single plant and that at least another 12 cases are being investigated. Heparin is used to prevent clotting among patients with kidney failure while they're undergoing dialysis.
While none of the reactions has been fatal, the CDC says, the symptoms are uncomfortable and potentially dangerous: "A probable case has been defined as an episode that includes at least two of the following signs and symptoms: 1) generalized or localized sensations of warmth; 2) numbness or tingling of the extremities; 3) difficulty swallowing; 4) shortness of breath, audible wheezing, or chest tightness; 5) low blood pressure/tachycardia; or 6) nausea or vomiting."
The A.P. identifies the states where allergic episodes have been reported as California, Florida, Minnesota, Missouri, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, West Virginia and Wisconsin.
"We don't know what the problem is," but heparin remains the leading candidate as the cause, CDC investigator Dr. Priti Patel told the wire service.
New Procedures at Yale Improve Safety in Obstetrics Department
Using their own obstetrics department as the focus, Yale School of Medicine researchers have devised a set of new procedures designed to reduce medical errors in obstetric care and improve the professional staff's perception of safety issues.
The results of the study and the new procedures were to be presented over the Feb. 2-4 weekend at the Society for Maternal Fetal Medicine Annual Meeting in Dallas, Tex., according to a Yale news release.
Dr. Edmund Funai, a Yale associate professor in the Department of Obstetrics, Gynecology and Reproductive Sciences, led a team that implemented new procedures in the OB-GYN department that have already reduced adverse outcomes in the department by more than 60 percent during the past 2.5 years, the news release said.
"Reports in the media about patient injury in the hospital setting were causing concern," Funai said in the news release, "and we sought to apply some basic principles to obstetric care to make it a great deal safer than it is right now."
Among those principles were communication training, standardizing interpretation of fetal monitoring and creating a new staff role -- patient safety nurse. An additional benefit was the professional staff's own perception of the overall safety climate. Its awareness of OB-GYN safety issues increased by 30 percent during the study period, the news release said.
FDA Approves 1st New Drug-Eluting Stent Since 2004
The U.S. Food and Drug Administration gave approval Friday to a new drug-eluting stent for use in treating patients with narrowed coronary arteries.
The Endeavor Zotarolimus-Eluting Coronary Stent, manufactured by Medtronic Inc., of Minneapolis, is the first such stent OK'd since 2004 and the first since an agency panel convened in 2006 to examine the risk of blood clots occurring in patients who receive drug-eluting stents.
Stents are tiny mesh tubes positioned in an artery to act as a scaffold that keeps a clogged artery open. Stents can be bare-metal or drug-eluting -- coated with drugs -- to ensure that the artery doesn't re-close in a process call restenosis.
According to the FDA, Medtronic provided data from seven clinical trials in its application showing that the Endeavor significantly reduced the number of major coronary events such as heart attack or cardiac death. The company said use of its product cut the restenosis rate by about half.
"The Endeavor drug-eluting stent provides cardiologists with another option for treating the one million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
U.S. Women's Heart Disease Deaths Continue to Decline
Heart disease deaths among American women declined again in 2005, marking the sixth consecutive year of decreases, according to a new analysis announced Friday by the U.S. National Heart, Lung, and Blood Institute.
It's the first time there's been a six-year consecutive decline.
The preliminary data analysis for 2005, the most recent year for which statistics are available, shows that women are living longer and healthier lives, and dying at much older ages than in the past.
"Considerable progress continues to be made in the fight against heart disease in women," NHLBI Director Dr. Elizabeth G. Nabel said in a prepared statement.
However, she noted there are still serious challenges. One in four women dies from heart disease and women of color have higher rates of some risk factors for heart disease and are more likely to die of the disease.
"Unfortunately, many women still do not take heart disease seriously and personally," Nabel said. "Millions of women still have one or more risk factors for heart disease, dramatically increasing their risk of developing heart disease. In fact, having just one risk factor increases a woman's chance of developing heart disease two-fold."
An NHLBI-sponsored campaign called "The Heart Truth" is striving to educate people that heart disease is largely preventable. As part of that campaign, Friday is National Wear Red Day, when thousands of people across the country wear red to give women a personal and urgent reminder about their risk for heart disease.
Marigold Therapies May Help Treat Stubborn Warts
Marigold-based therapies show promise in helping people with hard-to-treat warts, according to preliminary research by an assistant professor at Temple University School of Podiatric Medicine.
Tracey Vlahovic offers Marigold therapy -- creams, ointments, tinctures and oils -- to her patients and has investigated it as an alternative treatment for three HIV-infected patients with warts that hadn't responded to other treatments.
Plantar warts are common among healthy adults. In HIV patients, these warts are often more difficult to treat, more numerous and less receptive to common treatments such as cryotherapy or surgical removal.
Vlahovic found that four to six sessions of marigold-based therapy either cleared or greatly reduced the number and size of the warts. The findings were presented Friday at the American Academy of Dermatology's annual meeting.
"Mainstream treatments are sometimes not an option for HIV-positive patients because they have weakened immune systems and invasive procedures can further compromise them," Vlahovic said in a prepared statement. "But alternative therapies like Marigold therapy don't pose that threat."
She plans further research with more patients and a standardized treatment regimen.
Marigold plants have been used as a treatment for a variety of health problems as far back as ancient Greece and Rome, when marigold tea was used to combat sleep disorders and calm nerves. During the Renaissance, the yellow plant was used to treat everything from headache, red eyes and toothaches to jaundice and skin problems, the statement said.
Eye Drops and Eye/Ear Wash Recalled
Possible contamination with bacteria and particulate matter has prompted a voluntary recall of NuCel-brand eye drops and eye/ear wash, the U.S. Food and Drug Administration announced this week.
The problem was detected after an FDA inspection of the products made by NuCel Labs of Idaho Falls, Idaho, United Press International reported. The company then initiated a nationwide recall of the potentially non-sterile eye drops and eye/ear wash in 1/4-ounce bottles.
About 500 units of the products, which have no lot numbers or expiration dates, were distributed across the United States, the FDA said. Consumers should stop using these products and return them to the company. For further information, contact NuCel at 208-542-0325.
Non-sterile eye drops could cause infections which, in rare cases, could lead to blindness, the FDA warned. So far, there have been no reports of illness or injury caused by the recalled eye drops and eye/ear wash.