November 11th, 2008
By admin
Chantix has been linked to 10 suicides in the United Kingdom, according to that country’s health regulators.
This is the first time officials at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed the link between Chantix and suicide in that country. Earlier this year, the U.S. Food & Drug Administration (FDA) said it had linked 37 suicides to Chantix.
Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
But the drug has been the subject of disturbing side effect reports. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.
The MHRA also says the number of users reporting adverse side effects while using Chantix has doubled in the past seven months – up from 1,811 in February to 3,541 in September. The British health watchdog is now warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.
Last December, the European Medicines Agency ruled that the inserts in boxes of Chantix be updated to include warnings about suicide and depression.
Posted in Chantix, Uncategorized | No Comments »
November 6th, 2008
By admin
The Associated Press (AP) is reporting that Minnesota has joined many states seeking compensation from Lilly over the way it has marketed its popular anti-psychotic drug, Zyprexa.
Minnesota has joined several other states insurers, pension funds and unions accusing Lilly of concealing Zyprexa’s tendency to cause weight gain and diabetes and of marketing the drug for off-label uses.
The AP report notes Minnesota spent over $175 million through public health programs on Zyprexa prescriptions between 2000 and 2007. The lawsuit helps the state learn more about the drug’s impact on Minnesota through the discovery process. Lilly just recorded a third-quarter loss largely due to a $1.4 billion charge related to the investigation of Zyprexa marketing practices.
Zyprexa is a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania; however, internal Lilly documents and e-mail messages indicate Lilly marketed Zyprexa off-label. Zyprexa can cause severe weight gain and an increase in blood sugar in many patients. According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.
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November 6th, 2008
By admin
The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.
The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.
The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.
The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”
According to the FDA, it does no such thing.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Posted in Medical Device, Recall | No Comments »