- Scott Kappes | January 30, 2008 10:35 AM |
Category:
MiscellaneousA study suggests that confusion over drugs with similar looking and sounding names is more common than you might think. A report from the US Pharmacopeia that probed records from 2003-2006 found over 25,000 occurrences of "look alike/ sound alike" errors. Reporting of these errors is voluntary so the actual number of mistakes could be even higher. Nearly all of the errors did not cause any harm...
- Scott Kappes | January 29, 2008 4:27 PM |
Category:
FDA & Prescription DrugsYesterday a House subcommittee made allegations that FEMA employees manipulated scientific data in order to hide the dangers of toxic gas emitted into trailers housing survivors of hurricanes Katrina and Rita. The committee cited documents given to Congress alleging that Centers for Disease Control and Prevention (CDC) aided FEMA is concealing adverse health effects of long-term exposure to...
- Scott Kappes | January 25, 2008 10:58 AM |
Category:
FDA & Prescription DrugsI came across another frightening claim of psychotic behavior that appears could be linked to Pfizer's stop smoking drug Chantix. The story comes out of the UK where the drug is marketed as Champix. A woman living in the UK claims that on Christmas Eve her boyfriend who had been taking Champix for several months went what she described as "berserk." The woman claims that her boyfriend had been...
- Scott Kappes | January 23, 2008 10:40 AM |
Category:
Defective & Dangerous ProductsToymaker RC2, the makers of Thomas & Friends toy trains amongst other toys, has agreed to pay $30 million to settle a class action lawsuit resulting from last years toy recalls. Between June and September the company recalled over 1.7 million toys due to the use of lead paint in many of their toys. This was the first recall to raise substantial public awareness and concern about lead paint in...
- Scott Kappes | January 22, 2008 4:33 PM |
Category:
FDA & Prescription DrugsLast week the New England Journal of Medicine published an article claiming that the positive effect of antidepressants have been skewed way out of proportion by the lack of published reports that detail negative findings. After reviewing studies submitted to the FDA for 12 different antidepressants a report concluded that 88 per cent of studies that showed negative results were never published...
- Scott Kappes | January 21, 2008 4:53 PM |
Category:
FDA & Prescription DrugsLast Friday the FDA approved additional changes to the label of the once blockbuster Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary...
- Scott Kappes | January 18, 2008 1:46 PM |
Category:
FDA & Prescription DrugsToday Pfizer announced that the smoking cessation drug Chantix will now carry an additional warning advising doctors to monitor patients for changes in behavior, including but not limited to depressed mood, agitation, suicidal thoughts and suicidal behavior. While no causal relationship has been established between these changes and Chantix; however, Pfizer said a possible link couldn't be ruled...
- Scott Kappes | January 17, 2008 5:12 PM |
Category:
MiscellaneousI came across an interesting and strange story today that I thought I would throw out there. A lawsuit has been filed on behalf of 38-year-old Brian Persaud in response to him being forced to undergo a rectal exam in a New York ER. Persaud was taken to the ER at New York-Presbyterian Hospital/Weil Cornell Medical Center, after sustaining an injury at a Midtown construction site. Subsequent to...
- Scott Kappes | January 16, 2008 3:47 PM |
Category:
FDA & Prescription DrugsA new rule being proposed by the FDA would be welcomed by drug companies and could be a thorn in the side of plaintiffs' lawyers everywhere. The new rule would establish narrow guidelines under which drug companies can make changes to drug labels on their own. It may seem somewhat odd that drug companies would approve a narrowing of guidelines by the FDA, but it makes perfect sense when...
- Scott Kappes | January 15, 2008 11:55 AM |
Category:
FDA & Prescription DrugsA study released yesterday shows evidence that the blockbuster cholesterol medication Vytorin is not anymore effective than generic Zocor. Vytorin, a combination of Zetia and Zocor, is prescribed over 100,000 times each day generating over $5 billion in annual sales for Merck and Schering-Plough. Vytorin was shown to lower bad cholesterol levels better than Zocor alone, but showed no measurable...
- Scott Kappes | January 11, 2008 12:37 PM |
Category:
FDA & Prescription DrugsOn Wednesday the FDA sent letters to seven pharmacies ordering them to stop making false and misleading claims about custom-made "compounded" hormone products sold over the Internet to treat menopause. Claims that these synthesized hormones are more effective than approved menopause therapies are false according to the FDA and other experts. The FDA said in the letters that the claims made by...
- Scott Kappes | January 10, 2008 12:30 PM |
Category:
FDA & Prescription DrugsA November report by the Senate Finance Committee, based on the analysis of a Avandia by FDA scientists, estimates that Avandia has caused around 83,000 excess heart attacks since coming on the market in 1999. The statistics were presented at a July 30, 2007, safety panel meeting of experts to decide if Avandia should remain on the market. The panel did recommend that Avandia Remain on the...
- Scott Kappes | January 08, 2008 4:38 PM |
Category:
FDA & Prescription DrugsA class action lawsuit has been filed against pharmaceutical powerhouse Sanofi-Aventis alleging that the company hid data concerning adverse events associated with their obesity medication Zimulti. The French company allegedly concealed data showing Zimulti's propensity to cause depression. Zimulti has also been shown to increase suicidal ideation and action in some cases. In June the FDA...
- Scott Kappes | January 07, 2008 12:58 PM |
Category:
FDA & Prescription DrugsAnti-psychotic medications are only approved by the FDA to treat psychotic symptoms; however, it has become commonplace for health care professionals to use anti-psychotic medications to calm aggressive behavior through off-label use. There has never been any conclusive evidence to show this to be effective method, but a new study may shine a little more light on the issue. An article in the...
- Scott Kappes | January 02, 2008 5:20 PM |
Category:
FDA & Prescription DrugsLast week the CBS evening news featured a story on the possible relationship between Pfizer's smoking cessation drug Chantix and an increased risk of suicide. The story was centered on 33 year-old Amy Garza. Garza claims that shortly after starting Chantix she began to fall into what she described as a "psychotic breakdown." Garza made an attempt to take her own life shortly thereafter. Chantix...
- Scott Kappes | January 01, 2008 3:35 PM |
Category:
FDA & Prescription DrugsWith the New Year upon us millions of people will have made their New Year's resolution to quit smoking. They will seek every avenue available to help them through the quitting process. They will try nicotine patches and gum, and many will opt for Pfizer's Chantix to help them deal with the difficulties associated with quitting smoking. Smokers who decide to use Chantix to help them quit smoking...