פורום ארץ הצבי

''According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about [statin] side effects. The study suggests this pattern of reaction goes beyond statins to other drugs. When doctors fail to recognize a patient's symptoms as drug side effects, more than that patient's care is put at risk. Because the doctor makes no ''adverse event report'' to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.....patients surveyed said their doctors rarely linked their symptoms to statins - even when the symptoms were well-documented as side effects. ''Overwhelmingly, it was the patient that initiated that conversation'' making the connection between the statin and their symptoms, [survey author] Golomb said. Many doctors instead attributed the symptoms to the normal aging process, denied their connection to statins or dismissed the symptoms altogether -- missing opportunities to switch their patients' prescriptions or otherwise mitigate the side effects, Golomb said......The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn....'' - Ishani Ganguli, The Washington Post (August 28, 2007)

''The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a report in the September 10 issue of Archives of Internal Medicine......The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion,'' the authors write. A total of 1,489 drugs were associated with adverse events, but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6 percent of the total adverse event reports in the study....''Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time,'' the authors write.....''Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system.'' ......These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period,'' they conclude. ''The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.'' - Science Daily (September 10, 2007)