- Scott Kappes | November 30, 2007 5:34 PM |
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FDA & Prescription DrugsOn Wednesday the an FDA panel suggested that Cephalon's sleep disorder drug, Provigil, should care a stricter warning urging doctors not to prescribe the drug to children. The drug is approved to treat various sleep disorders in adults; however, doctors have been frequently prescribing the drug to treat the same disorders in children. The FDA is concerned that this could have serious adverse...
- Scott Kappes | November 29, 2007 11:33 AM |
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FDA & Prescription DrugsYesterday a panel of outside experts commissioned by the FDA advised the administration that the popular asthma medications Advair and Serevent should carry an additional warning for use in children. The new warning, if accepted by the FDA, will reportedly advise of a potential increased risk of asthma related hospitalization. The panel also said the warning should be more specific for children....
- Scott Kappes | November 28, 2007 10:14 AM |
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FDA & Prescription DrugsYesterday the U.S. Food and Drug Administration voted to revise the labels of the popular flu medications Tamiflu and Relenza. The new warnings will inform consumers of possible psychiatric problems associated with the drugs. There have been numerous reports of delirium and hallucinations tied to the drug, the majority coming from Japan, but no causal relationship has been confirmed. The new...
- Scott Kappes | November 27, 2007 11:49 AM |
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Medical MalpracticeA Rhode Island hospital has been fined $50,000 and reprimanded by the Department of Health after a doctor performed brain surgery on the wrong side of a patient's brain. While this sounds terrible it gets even worse. This is the third time this has happened this year at this hospital alone. Last Friday marks the most recent occurrence when the chief resident began operating on the wrong side of...
- Scott Kappes | November 26, 2007 9:37 AM |
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FDA & Prescription DrugsFlu medications have been under fire in other countries, particularly Japan, for years now. Patients in Japan have frequently complained of very uncharacteristic behavior while taking drugs like Roche's Tamiflu and GlaxoSmithKline's Relenza. The behaviors reported include hallucinations and other strange reactions. The FDA has recently received similar reports from patients in the United States....
- Scott Kappes | November 21, 2007 9:07 AM |
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FDA & Prescription DrugsThe Food and Drug Administration is currently is the process of further review of the smoking cessation drug Chantix. This review comes in response to numerous complaints of erratic behavior and suicidal ideation from users of the drug. Pfizer, the manufacturer, was hoping that Chantix could become a blockbuster drug recognized as the common treatment for smoking cessation. By looking at sales...
- Scott Kappes | November 19, 2007 3:58 PM |
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FDA & Prescription DrugsAn agreement was reached to settle the overwhelming majority of cases resulting from injuries related to Vioxx. Many have carefully examined wording of the agreement and it seems that Merck may have ended up in a better position than once speculated. The $4.85 billion deal includes a peculiar provision that says if a lawyer has one client enroll in the deal, the attorney must recommend the deal...
- Scott Kappes | November 16, 2007 11:51 AM |
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FDA & Prescription DrugsOn Wednesday the FDA announced that the type-2 diabetes drug Avandia would now carry a additional "black box" warning. The "black box" warning is the strictest label that can the FDA can place on a medication. The new warning will cite a May New England Journal of Medicine article that demonstrated a possible link between Avandia and an increased risk in heart attack. The warning does not...
- Scott Kappes | November 14, 2007 9:56 AM |
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FDA & Prescription DrugsJust over a year ago pharmaceutical giant Pfizer introduced a revolutionary smoking cessasation drug to the market. This drug, called Chantix, work differently than stop smoking aids in the past. Chantix actually blocks nicotine receptors in the brain, eliminating the satisfaction induced by nicotine consumption therefore eliminating the urge to smoke. Over 4 million people have tried Chantix...
- Scott Kappes | November 13, 2007 4:36 PM |
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FDA & Prescription DrugsMonday a medical journal published findings suggesting that St. Jude's defibrillator leads may puncture the heart on rare occasions. Four cases were highlighted Monday's PACE Journal publication. The cases in question involve St. Jude's Riata leads; two cases were reported in the Czech Republic and two more in the United States. A 71-year-old New York woman's Riata lead came within a quarter of...
- Scott Kappes | November 09, 2007 12:05 PM |
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FDA & Prescription DrugsToday Merck & Co. announced that they will pay $4.85 billion to settle the thousands of Vioxx suits. This is not a class action settlement. Merck will place the money in a fund and those who claim to have been injured by the drug will be able to petition for the money. They say that each individual case will be assessed before payment is made. Merck had previously claimed that they fight every...
- Scott Kappes | November 08, 2007 9:39 AM |
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Defective & Dangerous ProductsYesterday the Consumer Products Safety Commission announced the recall of 4.2 million Aqua Dot Chinese made toys. The toys allegedly contain a "date rape" drug that can pose a serious risk to children. The Craft toys contain 1,4, butanediol on their beads which if ingested can cause unconsciousness, respiratory depression and seizures. The Aqua Dot toys had made Wal-Mart's list of the top 12...
- Scott Kappes | November 02, 2007 11:50 AM |
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FDA & Prescription DrugsYesterday federal agents raided a St. Louis drug company after being tipped off that the company was hiding drug products behind a fictitious walls and manufacturing medications under unsanitary conditions. The company, General Therapeutics Corp., produces over the counter medications for both humans and animals, dietary supplements, vitamins, and NC solution. Agents from the FDA and the U.S....
- Scott Kappes | November 01, 2007 2:20 PM |
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Defective & Dangerous ProductsEarlier this month the FDA issued a Class I Recall on defibrillator wires that connect implanted defibrillators to the heart. The wires, (leads) were manufactured by Medtronic Inc., one the leaders in this market. The Sprint Fidelis leads were linked to several reports of patients receiving unwarranted shocks from their defibrillators. Plaintiffs' attorneys have begun filing lawsuits against the...