On July 1, the FDA said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of Chantix, a popular smoking cessation drug. The warning is a result of countless reports of behavioral changes, depressed mood, agitation, hostility, and suicidal thoughts and behavior associated with use of the drug.
Chantix is so dangerous that the agency reported 98 suicides and 188 attempted suicides in Chantix users, yet according to Curtis Rosebraugh, MD, director of the agency’s Office of Drug Evaluation II, discontinuation of the medication is not recommended because it has shown to be effective for quitting smoking.
The FDA further recommends, in its infinite wisdom, that “clinicians monitor their patients for neuropsychiatric symptoms after initiating treatment. ” Well, that’s all fine and dandy if you and your doctor have the time, and you have health insurance. But more often than not, people with behavioral changes noted above do not seek medical help, and several people I have spoken with, who have suffered Chantix side effects, can’t afford to see a doctor on a constant basis.
Of course illnesses and deaths caused by smoking has cost a gazillion dollars to the medical system and hey, I’m not condoning smoking but it seems like the FDA needs a lesson in common sense, and reconsider taking Chantix off the market before they have more reported suicides.
The June issue of the American Journal of Roentgenology (as reported by docguide.com) has the results of a new study on MRI health risks–particularly those associated with gadolinium contrast. According to the docguide.com article,
“Even at very high doses, gadolinium-based contrast agents alone are not sufficient to cause nephrogenic systemic fibrosis (NSF) in patients with kidney problems,…”
That’s a statement that caught my eye given all the prior studies on the risks of gadolinium as an MRI contrast agent and its connection to Nephrogenic Systemic Fibrosis (NSF).
In the study, led by Dr. Mellena D. Bridges, of the Mayo Clinic, Jacksonville, Florida, records of 61 patients who received high-dose IV gadodiamide for catheter angiography or computed tomography (CT) between January 2002 and December 2005 were examined. Read the rest of this entry »
It is estimated that one in every ten people will take a fluoroquinolone antibiotic during the course of their lifetime, and chances are it would either be Cipro or Levaquin, the two big blockbuster drugs. Take this statistic, add the fact that the FDA says less than 10 percent of all drug side effects ever get reported to their agency, and throw in the equation that many US troops were given Cipro, chances are countless people have suffered tendon tears and ruptures from these drugs. And according to Cipro patients writing online, Cipro’s adverse events are not as rare as the drug manufacturer—Bayer—would have the public believe.
And let’s not forget the Anthrax scare in 2001—if you recall, the antidote to have on hand and the drug that became the media darling during that scare was none other than Cipro. Read the rest of this entry »
Attorney Mike Stratton points out that Bayer’s patent on Cipro will expire soon and Ortho-McNeil’s blockbuster Levaquin has been targeted for the majority of lawsuits against the flouroquinolones family, so it is likely that Bayer may soon push sales of its more quiet cousin Avelox—described by Stratton as “the elephant in the room”.
Flouroquinolone antibiotics are the most commonly prescribed class of antibiotics, yet many of them have been removed from the market due to their severe toxicity (e.g., Trovan, Tequin, Zagam, and Omniflox). Is it just a matter of time until Avelox is taken off the market or does Bayer have more control over its drugs than the FDA? (According to one website, the FDA gets about half of its funding for the review of drugs directly from the pharmaceutical industry in what is called prescription drug user fees.)
Although Avelox was slapped with a black box warning regarding tendon tears and ruptures, Bayer says that Avelox (and its close relative Cipro) are “effective and well tolerated” but try telling that to the many victims who have registered complaints on medical websites and their own personal blogs. This from one Avelox victim: “…yes, the potential for a ruptured tendon was mentioned in the [Avelox] box insert. But it was printed, like everything else was, in teeny tiny type. And of course, we never think WE are the people who will have the problems, do we?)”
Like that woman who suffered ankle tears, not everyone prescribed Avelox and suffering from tendon ruptures will make the connection between the drug and adverse events right away. After all, drug side effects actually reported to the FDA typically only involve about 1 percent to 10 percent of all problems experienced by users. However, there will likely be many Avelox lawsuits soon–just take a look at Levaquin.
Watching the events unfold in Iran over the past week has proven a startling reminder of the power of shared information, especially as it applies to the Internet. The beauty of the Web is that people can share their experiences in their own voice, regardless of whether that experience is about an election gone terribly wrong, the death of a Pop legend such as Michael Jackson, or a woman’s own story about a terrible event in her life. That sharing of information not only helps keep people informed, but in some cases galvanizes them into action. Angela Beck is counting on both. Read the rest of this entry »