FDA puts black box warning on bowel-clearing drugs

news.yahoo.com — Federal health officials said Thursday they will add the sternest safety warnings available to prescription drugs used to cleanse the bowel before colonoscopies. The Food and Drug Administration said it has received more than 20 reports of a rare but serious form of kidney failure among patients taking the drugs, known as oral phosphate products. The new boxed warning label will apply to Visicol and OsmoPrep — both prescription tablets made by Salix Pharmaceuticals. The label warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease or those that take medications that affect the kidneys. read more...

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FDA advisers recommend approval of new gout drug

news.yahoo.com — Government health advisers Monday recommended approval of the first new drug in 40 years for gout, a painful joint disease that mainly strikes middle-aged men. About 5 million people in the U.S. suffer from gout, a form of arthritis caused by a build-up of uric acid in the blood. Uloric, as the new drug is called, works by reducing levels of uric acid. In healthy people, uric acid is dissolved in the blood and excreted from the body in urine. But high levels lead to the formation of needle-like crystals that become deposited in the joints, causing intense pain and swelling. Many patients experience their first attack of gout in the big toe. The disease can progress, causing deformities. Food and Drug Administration medical reviewers were concerned because early trials of Uloric found a higher risk of death and heart problems from the drug. But Takeda Inc., which makes Uloric, commissioned a much larger clinical study that found no difference in heart risks when compared with the currently available drug, allopurinol. read more...

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Gov't seizes more contaminated heparin

news.yahoo.com — WASHINGTON – Federal agents Thursday seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati, officials said. The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis, was the focus of a major recall earlier this year after crude drug material from China was found to be contaminated. Hundreds of frail patients suffered severe allergic reactions. The government received reports of nearly 250 deaths. The FDA had inspected the Cincinnati company, Celsus Laboratories, Inc., in April and at the time found contaminated heparin in two different kinds of products, officials said. A little over 2 pounds of the blood thinner was intended for use directly with patients, and another 31 pounds was to be utilized in diagnostic test kits and medical devices. The FDA seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory, the agency said in a statement. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes. read more...

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Va. pharmacy follows faith, no birth control sales

health.yahoo.com — A new drug store at a Virginia strip mall is putting its faith in an unconventional business plan: No candy. No sodas. And no birth control. Divine Mercy Care Pharmacy is among at least seven pharmacies across the nation that are refusing as a matter of faith to sell contraceptives of any kind, even if a person has a prescription. States across the country have been wrestling with the issue of pharmacists who refuse on religious grounds to dispense birth control or morning-after pills, and some have enacted laws requiring drug stores to fill the prescriptions. read more...

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Medicare officials advise seniors to shop around

news.yahoo.com — Federal health officials encouraged Medicare participants on Thursday to shop around for their prescription drug coverage next year because it could include significant price increases or changes regarding which drugs the plans will cover. Overall, the landscape for prescription drug coverage won't look dramatically different next year. The typical beneficiary will still have dozens upon dozens of plans to choose from, but most people will see an increase in their monthly premiums if they stay with the same insurer. For those enrolled in the 10 most popular drug plans, the cost increases will range from 8 percent to as much as 64 percent, according to an analysis by Avalere Health, a consulting firm. read more...

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FDA posts list of potential problem drugs

news.yahoo.com — The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed. Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation. read more...

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Methadone Rises as a Painkiller With Big Risks

nytimes.com — Suffering from excruciating spinal deterioration, Robby Garvin, 24, of South Carolina, tried many painkillers before his doctor prescribed methadone in June 2006, just before Mr. Garvin and his friend Joey Sutton set off for a weekend at an amusement park. Skip to next paragraph Multimedia The Methadone BoomGraphic The Methadone Boom Related F.D.A. Weighs Training to Dispense Narcotics (August 17, 2008) Times Topics: Methadone Stephen Morton for The New York Times IN MEMORY Nancy Garvin with a photo of her son Robby at a garden she had made for him in Beaufort, S.C. Robby, who had severe back pain, died at 24. On Saturday night Mr. Garvin called his mother to say, “Mama, this is the first time I have been pain free, this medicine just might really help me.” The next day, though, he felt bad. As directed, he took two more tablets and then he lay down for a nap. It was after 2 p.m. that Joey said he heard a strange sound that must have been Robby’s last breath. read more...

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Home deaths from drug errors soar

edition.cnn.com — CHICAGO, Illinois (AP) -- Deaths from medication mistakes at home, such as actor Heath Ledger's accidental overdose, rose dramatically during the past two decades, an analysis of U.S. death certificates finds. The authors blame soaring home use of prescription painkillers and other potent drugs, which 25 years ago were given mainly inside hospitals. "The amount of medical supervision is going down and the amount of responsibility put on the patient's shoulders is going up," said lead author David P. Phillips of the University of California, San Diego. read more...

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