- Scott Kappes | February 28, 2008 5:36 PM |
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MiscellaneousThis week a small Alaska village has filed a lawsuit against a dozen oil, power, and coal companies alleging that the large amounts of greenhouse gases emitted by the companies contributed to global warming that threatens the community's existence. The town of Kivalina, the home of a federally recognized tribe, has filed the lawsuit in the federal court of San Francisco. Kivalina is located...
- Scott Kappes | February 26, 2008 7:36 PM |
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FDA & Prescription DrugsToday an article published in the Journal of the American Medical Association claims that commonly used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death in cancer patients by about 10 percent. The publication, based on new analysis of existing clinical trial data, comes just as the FDA is planning to convene an advisory panel to address concerns associated with the...
- Scott Kappes | February 26, 2008 11:34 AM |
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FDA & Prescription DrugsTwo studies published in the New England Journal of Medicine have linked the drug Trasylol, used to reduce bleeding during open-heart surgery, to an increased risk of death and kidney damage among other concerns. Patients taking Trasylol were found to be 27 percent more likely to die a decade after surgery than those who received a rival drug in a study of over 10,000 patients. Another study of...
- Scott Kappes | February 25, 2008 4:05 PM |
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Defective & Dangerous ProductsToday the FDA issued a warning to consumers about the safety of denture cleaning products. The warning was prompted by the death of one person and allergic reactions experienced by at least 72 others. The FDA said that some but not all of the reactions resulted from improper use of the products. The likely culprit is a bleach called persulfate, an allergen found in nearly every denture cleanser...
- Scott Kappes | February 22, 2008 3:26 PM |
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Defective & Dangerous ProductsA Texas housewife has filed a lawsuit against DuPont, Union Carbide and others alleging that she was exposed to asbestos over a 27-year period from washing her husband's work clothing. The plaintiff, Frances Barras, who suffers from an asbestos related illness, claims that her sickness results from the washing of her husband's contaminated clothing. The lawsuit claims that Barras inhaled great...
- Scott Kappes | February 21, 2008 2:52 PM |
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Defective & Dangerous ProductsOn Wednesday the Supreme Court sided with medical device makers; delivering an 8-1 decision in favor not allowing patients injured by an FDA approved medical device to file lawsuit against the manufacturer. The Court cited a 1976 law that they say bars state-law claims challenging the safety and efficacy of medical devices that have been received pre-market approval from the FDA. The ruling only...
- Scott Kappes | February 20, 2008 6:11 PM |
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Defective & Dangerous ProductsKimlyn Cline of Kilgore, Texas has filed a product liability lawsuit against Advanced Medical Optics, the makers of Complete Moisture Plus Multi-Purpose disinfectant contact lens solution, alleging that the solution did not disinfect as advertised causing her to develop an eye infection. Cline's infection even with treatment worsened and she is now in need of corneal transplant surgery. The...
- Scott Kappes | February 20, 2008 9:42 AM |
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FDA & Prescription DrugsA report published today claims that clinical trials will begin next month to see if Pfizer's stop smoking drug, Chantix, can be an effective treatment for curbing drinking and gambling habits. The drug has been shown to be effective in treating smoking addiction, but has been met with widespread controversy over a possible link to neuropsychiatric events, including suicidal ideation and...
- Scott Kappes | February 19, 2008 1:08 PM |
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FDA & Prescription DrugsThe FDA recently released a draft of guidelines that would allow drugmakers to distribute reprints of peer-reviewed journal articles that suggest off-label uses for their medications. Doctors have always been able to prescribe drugs as they see fit and off-label prescription is commonplace throughout the medical field, but drugmakers have never been allowed to promote medications for any use...
- Scott Kappes | February 18, 2008 6:27 PM |
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FDA & Prescription DrugsToday Actavis South Atlantic LLC announced the recall of several lots of fentanyl pain patches. This is the second recall of fentanyl pain patches in one week's time. Last week Johnson & Johnson issued a recall of specific lots of 25 microgram per hour Duragesic pain patches, for a risk that the some patches may have a defect that allows the medication to be releases faster than intended,...
- Scott Kappes | February 18, 2008 12:25 PM |
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FDA & Prescription DrugsA former clinical research associate who worked on the clinical trials for the antibiotic, Ketek, said that researchers and Sanofi-Aventis worked together to defraud the FDA. Ketek has been linked to liver problems and according to allegations by the FDA the manufacturer, Sanofi-Aventis, made deliberate efforts to conceal evidence that would be harmful to the drug during the post marketing...
- Scott Kappes | February 14, 2008 9:59 AM |
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Defective & Dangerous ProductsYesterday Johnson & Johnson announced a voluntary recall of a popular version of their Duragesic pain patch. About 32 million patches sold by PriCara, a unit of J & J, are being recalled due to concerns that a defect could expose patients to excess doses of the powerful opioid, fentanyl, leading to respiratory difficulties and even death. The company estimates that defects exist in two out of...
- Scott Kappes | February 13, 2008 4:19 PM |
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FDA & Prescription DrugsA writer for New York Magazine recently published an article entitled, "My Brain on Chantix," revealing his personal experiences while taking Chantix. Derek de Koff says in the article that he never believed the stories of Chantix contributing to the tragic shooting death of Carter Albrecht, that is until he began taking the drug himself. Chantix has been hailed by many as a "miracle drug," but...
- Scott Kappes | February 11, 2008 12:01 PM |
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Defective & Dangerous ProductsFor the first ever FDA scientists will be evaluating the safety of the materials used in tattooing. The investigation was incited by numerous reports of skin irritation following a tattooing session. The FDA wants to know how the chemicals break down, and if any pose a threat to the individual's safety. If the FDA finds it necessary to enact changes or limitations it could have a huge impact on...
- Scott Kappes | February 08, 2008 4:18 PM |
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FDA & Prescription DrugsToday the FDA issued an Early Communication about an ongoing study on the use of Botox. The communication was issued in response to a small amount of deaths and other severe side effects suggestive of botulism associated with the drug. Botox is commonly used to block nerve impulses allowing muscles to relax, therefore eliminating involuntary twitches and spasms. In recent years Botox has been...
- Scott Kappes | February 07, 2008 12:32 PM |
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Tractor-Trailer AccidentsIn August of 2004 Ruben Zamora, 41, was severely injured when he was involved in a rollover accident in his 1993 Ford Explorer. Zamora lost control of the vehicle when the tread of one of the back tires separated causing the tail end of the SUV to swing sideways and resulted in the rollover. Zamora was ejected from the vehicle during the rollover. The previously disabled oilfield worker suffered...
- Scott Kappes | February 06, 2008 4:03 PM |
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FDA & Prescription DrugsToday a panel of outside experts will examine advise the FDA on whether or not a new injectable version of the popular schizophrenia drug, Zyprexa, should be approved in the US. Zyprexa is currently available in a once-daily pill form, but the new formula, Zyprexa Adhera, can be injected into the muscle and last up to four weeks. The panel will weigh all aspects of the drug and available...
- Scott Kappes | February 06, 2008 9:56 AM |
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FDA & Prescription DrugsOn Friday the FDA issue a Public Health Advisory for Pfizer's popular smoking cessation drug Chantix. This advisory comes just two months after an Early Communication advised physicians of a possible link between Chantix and neuropsychiatric symptoms. The FDA has now said that it is becoming increasingly likely that this association exists. The shooting death of Dallas musician Carter Albrecht,...
- Scott Kappes | February 01, 2008 11:46 AM |
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FDA & Prescription DrugsYesterday the FDA announced the findings of a two-year study on medications used to treat epilepsy and bi-polar disorder. The combined analysis of almost 44,000 patients in 199 clinical trials found that the drugs tested were twice as likely to produce suicidal thoughts in patients, when compared to those treated with a placebo. The study found 4 suicides and 105 reports of suicidal ideation...