Mechanical Heart Pump Recalled After Deaths
Certain batches of a small mechanical heart pump have been recalled by the manufacturer, after five people died while using the device.
Thoratec Corp. of Pleasanton, Calif., urged patients with a HeartMate II pump to have their implants checked after the company said 27 had to be replaced because of wear and fatigue to an electrical wire, the Associated Press reported.
In five cases, the device could not be replaced and the patients died, the company said in a news release. The reports occurred over five years of clinical experience with 1,972 implants, the company added.
The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003.
The HeartMate II pump was approved in April as a temporary treatment for patients awaiting heart transplants, but analysts had said the larger market for the product is in "destination therapy," or patients with end-stage heart failure who are too ill for a transplant, according to AP.
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Rotavirus Vaccine Cuts Infant Diarrhea
A vaccine against rotavirus, which causes vomiting and diarrhea in thousands of children annually, reduced the number of new cases of the illness by at least two-thirds in its second year of use, researchers reported Saturday.
Rotateq, made by Merck and approved in 2006, worked so well that it may also have cut the spread to non-immunized children in the United States, according to research by the U.S. Centers for Disease Control and Prevention and Quest Diagnostics.
The vaccine appeared to interrupt the spread of the disease in older children who couldn't have been immunized, Jay Lieberman, medical director of infectious diseases for Quest's Focus Diagnostics unit, told Bloomberg News.
"We saw marked declines of rotavirus in every age group, including those 2-to-6 years old for whom the vaccine isn't recommended," he added. "That's because a 2-month old who was vaccinated was less likely to infect the older brother or sister, or other children in day-care who weren't vaccinated."
Although CDC researchers also found large reductions in the number of children with rotavirus, they lacked data on children's ages that would have pointed to herd immunity, which is a community's resistance to illness, said Umesh Parasher, head of the CDC rotavirus epidemiology team.
Lieberman and Parasher presented their results at a joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Disease Society of America in Washington.
Lieberman looked at 132,000 rotavirus cases recorded in Quest's database from 2003 through July 2008. Positive tests declined 76 percent in the two most recent seasons compared with the 2003 through 2006 seasons, before Rotateq was cleared for sale, Bloomberg reported.
Parasher looked at cases from 2000 through July 2008, using data from 33 laboratories that are part of a voluntary reporting system across the country. His study found a 67 percent decline in rotavirus cases in the most recent two years, compared with 2000 through 2006.
According to the CDC, 55,000 children are hospitalized annually because of illness and dehydration caused by rotavirus, and the disease kills more than 600,000 children worldwide each year.
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Tagless Label Ink May Cause Baby Rashes
About 400 babies have developed skin rashes from wearing certain knit items sold by Carter's Inc., a major baby and children's clothing retailer
According to the Associated Press, about 400 incidents of rashes occurring on babies' backs have been reported, and officials suspect the cause may be the ink in the tagless labels on the garments.
The warning applies to the fall 2007 line of garments, such as baby knit body suits, shirts and pajamas, the AP reports, and it covers all 110 million items produced.
The rash incidents appear to come from the ink on the heat-transferred, tagless labels on the back of garments, according to an announcement on the Carter Web site. "It appears that a very small percentage of children can be allergic to one or more ingredients in the labels. The solid, rather than stenciled, background on the fall 2007 labels appears to have produced a more pronounced and noticeable reaction among those children who are most allergic to the ink," the announcement said.
A Carter company manager in Atlanta, would not comment to the AP on whether any of the rashes were serious enough to cause hospitalization.
Carter's has established a consumer phone number to answer questions: 888-282-4674
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New Test Checks Embryos for 15,000 Inherited Diseases
British researchers say they've developed a gene mapping test that, within a matter of weeks, can determine whether an embryo is affected by any one of 15,000 inherited diseases. Current tests focus on a specific gene mutation or can take much longer to provide results.
For the new test, a single cell is taken from an 8-day-old embryo. DNA samples are then collected from the parents and their parents. In many cases, a DNA sample is taken from another member of the family, such as a child affected by an inherited disease, BBC News reported.
All the family members' DNA is analyzed for 300,000 specific DNA markers, creating a map of the family's genetics, said Prof. Alan Handyside and colleagues at London's Bridge Center, who are currently conducting trials of the gene-mapping test.
"The effectiveness and efficiency of the procedure is quite exciting, and the fact that it's quicker means it could be helpful to couples at risk of inherited diseases -- and that in itself is significant," Dr. Mark Hamilton, chairman of the British Fertility Society, told BBC News.
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Sales of Anti-Obesity Drug Acomplia Suspended in Europe
Hours after European health authorities warned doctors to stop prescribing the anti-obesity drug Acomplia (rimonabant), the drug's maker announced Thursday that it was suspending European sales, the Associated Press reported.
Earlier, the European Medicines Agency (EMEA) warned that patients who took the drug had approximately twice the risk of serious psychiatric problems.
Maker Sanofi-Aventis said Acomplia has been sold in 18 European Union countries since 2006. The company said it would immediately begin talks with nations outside the EU to suspend sales in those countries as well, the AP reported.
The U.S. Food and Drug Administration last year refused to approve the drug, citing company studies that associated it with depression, anxiety and stress disorders.
In its warning Thursday, the EMEA said people taking the drug didn't need to immediately stop using it, but should consult their doctor. It also urged physicians to review the cases of anyone taking the drug.
There have been ongoing concerns about the risks of depression and suicide among patients taking Acomplia. Last year, the EMEA said the drug may be unsafe for patients also taking antidepressants, BBC News reported.
At that time, doctors were also advised not to give the drug to people with a history of major depression, and to watch for new symptoms of depression in people already taking the drug.
Between June and August 2008, BBC News reported, there were five suicides among clinical trial participants taking the drug, compared to one suicide among participants taking a placebo.
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