The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides...Pfizer said Tuesday.This "approval includes children whose high blood fats are due to...familial hypercholesterolemia.
Doctors Identify Two Therapies That May Slow Progress Of Diabetic Retinopathy.
The Los Angeles Times blog reported that, according to data published June 29 in the New England Journal of Medicine and presented at the American Diabetes Association meeting, "doctors said they have identified two therapies that may slow the progress of" diabetic retinopathy. After examining data on a subset of 2,856 people from the ACCORD study, researchers found that "people with type 2 diabetes who adhere to intensive blood sugar control, compared with standard blood sugar control, have reduced progression of retinopathy. In addition, patients treated with a combination of a cholesterol-lowering statin and fibrate drugs also had a lower rate of progression compared with patients taking statins alone."
http://latimesblogs.latimes.com/booster_shots/2010/06/diabetes-retinopathy-glucose-control.html http://content.nejm.org/cgi/content/full/NEJMoa1001288 http://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm
Weight-Loss Supplement Contains Potentially Dangerous, Undeclared Drug Ingredients, FDA Warns.
MedPage Today reported, "The FDA warned customers about several potentially dangerous and undeclared drug ingredients in Que She, a pill sold as an herbal weight-loss supplement." Specifically, the "supplement contains fenfluramine, a stimulant drug withdrawn from the market because it may cause serious heart valve damage; propranolol, a prescription beta-blocker that may be hazardous to patients with bronchial asthma or certain heart conditions; sibutramine, a controlled, prescription weight-loss drug that studies have shown may increase heart attack and stroke risk; and ephedrine, a stimulant that is sold over-the-counter for temporary asthma relief but may have adverse cardiovascular effects.
Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems."
The CBS Evening News reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market." NBC Nightly News reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe."
The Washington Post reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times reported that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine."
Bloomberg News quoted "I think we've got more than enough evidence to say this drug should not be used." USA Today reported that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death." The Boston Globe quoted the study's coauthor Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'"
The New York Times reported that "the studies were made public in hopes of influencing an expert panel to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." The AP reports that "at the FDA's request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan's Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue."
The NPR blog reported that "Glaxo, for its part, defended the medicine, saying in a statement that randomized clinical trials have shown 'Avandia does not increase the overall risk of heart attack, stroke or death.'"
http://archinte.ama-assn.org/cgi/content/abstract/2010.207v1?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Avandia&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT http://www.bloomberg.com/news/2010-06-28/glaxo-diabetes-drug-avandia-harms-patients-should-be-pulled-doctors-say.html http://www.usatoday.com/news/health/2010-06-28-Avandiaheartrisks-diabetes_N.htm http://jama.ama-assn.org/cgi/content/full/jama.2010.920 http://www.boston.com/business/healthcare/articles/2010/06/29/new_studies_add_to_avandia_concerns/ http://www.nytimes.com/2010/06/29/health/research/29drug.html?_r=1&ref=health http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-med-diabetes-drugs_7726225.html
http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html?mod=googlenews_wsj http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://www.reuters.com/article/idUSN2826887120100628