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French health estimates delve into Pill risk Posted: 27 Mar 2013 11:49 PM PDT A French drug watchdog on Tuesday released estimates for blood clots linked to birth control pills in the wake of fears that so-called third- and fourth-generation oral contraceptives boost a small risk of dangerous thrombosis. Between 2000 and 2011, contraceptive pills were linked on average to 2,529 annual cases of blood clots, the National Agency for the Safety of Drugs and Health Products (ANSM) said. Of the tally, 1,751 were attributable to third- and fourth generation pills, it said. On average, 20 fatalities annually could be linked to contraceptive use, six of which could be attributed to first- and second-generation pills and 14 to the later-generation pills, the agency said. "The risk of venous thromboembolism applies to the population as a whole, but the risk is low," the ANSM said in a press release. "It increases with age for all women, regardless of whether they use oral contraceptives or not. It is higher for users of third- and fourth-generation contraceptives than for users of first- and second-generation contraceptives," it said, reiterating an earlier judgement. Clots that lodge in the veins can be highly dangerous, potentially causing strokes or heart attacks. The ANSM estimates are based on a statistical model, not on an analysis of individual cases. Smoking and obesity are also associated with higher risk of clots. More than four million women annually took oral contraceptives during the 2001-2011 period, roughly half of whom took first- and second-generation pills and the remainder third- and fourth-generation. The third-generation Pill, introduced in the 1990s, and the fourth generation, approved in the last decade, are formulated to have synthetic versions of the female hormone progestogen, the idea being to skirt side-effects associated with older contraceptives. In January, the health ministry called on doctors to prescribe third- and fourth-generation pills only "in very specific circumstances" and never as a first option. It also urged the European Medicines Agency (EMA) to alter its guidelines accordingly. The EMA said on January 28 that it would study the request. The health ministry also dropped the two later generations of the Pill from the list of medications that are reimbursed under France's national health-insurance programme. The ANSM said that figures for February showed a slump in sales of 34 percent for third- and fourth-generation pills, and a rise of 27 percent for first- and second-generation alternatives, as women made the switch. The storm in France has been triggered in part by the case of a 25-year-old woman, Marion Larat, who was left badly handicapped by a stroke that, in a lawsuit, she attributes to a later-generation pill made by Bayer. A Danish study published in the British Medical Journal in 2011 found women who took one of the newer types of Pill ran twice the risk of developing venous thromboembolism compared to counterparts who used older-generation pills. Compared with non-users of the Pill, the risk of a clot was between three and six times higher. In absolute terms, though, the risk from the newer contraceptives was small, the investigators said. -- AFPRelaxnews |
Chelation therapy still not proven to work: study Posted: 27 Mar 2013 10:57 PM PDT A new National Institutes of Health (NIH) study on chelation therapy, a controversial procedure that some 110,000 Americans undergo every year, finds that it's not ready for prime time. The decade-long study found that chelation slightly reduced the risk of heart problems, mostly in people with diabetes. But the researchers say that the benefit is so slim that it could have been due to chance. The findings were published Tuesday in the Journal of the American Medical Association. Among the 1,708 heart attack survivors enrolled in the study, 26.5 percent of those randomly assigned to chelation later experienced a heart problem, compared with 30 percent of those randomly assigned to a placebo. Chelation therapy most often involves the injection of ethylene diamine tetraacetic acid, a chemical that binds, or chelates, heavy metals, including iron, lead, and mercury. While chelation has been practiced for decades, it's considered an alternative treatment, and there are real risks, critics say. When administered too quickly, the treatment can lead to a fatal drop in calcium levels in the blood. The study "should serve to dissuade responsible practitioners from providing or recommending chelation therapy for patients with coronary disease," the journal's editors wrote in an editorial. ABC News reported that the study, however, could be misused as a tool for practitioners to further market the procedure. -- AFPRelaxnews |
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