› $4.85 Billion settlement in drug case
In September, we learned that those long Chantix ads featuring the tortoise and the hare were reappearing on TV after Pfizer yanked them from the airwaves for several months. The drug maker pulled the ads when it became evident that a link existed between Chantix, depression, and suicide. Unfortunately, the new ads were even longer than the original by 30 seconds — for a total of 90 seconds — to accommodate all the new warnings.
According to The Institute for Safe Medicine Practices (ISMP), the number of drug-related adverse events and deaths reported to the Food and Drug Administration has hit a record level. Numbers pulled from the FDA’s Adverse Event Reporting System (AERS) reveal that Heparin and Chantix are largely to blame for the upward swing.
By now we know that Chantix is dangerous for some people who use the drug, but mounting evidence suggests that people who don’t use it may also be harmed. Since Chantix became available for smoking cessation in August of 2006, the FDA has received a steady influx of reports connecting the drug to traffic accidents. Moreover, while the medical community and the media are focused on the negative psychiatric effects that some Chantix users experience, researchers now believe that the non-psychiatric effects may be worse.
Many medical researchers find little surprise that Chantix has been linked to higher than normal rates of depression and suicide. Varenicline (the chemical name of Pfizer’s smoking cessation drug) goes to work directly in the brain by targeting certain receptors and simulating that feeling of having already smoked – that “full” feeling smokers feel after they’ve lit up one or two. Other pharmaceuticals that go to work directly in the brain include antidepressants, some of which have also been linked to behavioral problems and suicide.
Next week, Pfizer will once again be running Chantix ads on television. Pfizer stopped running Chantix ads last year amid increasing concern over the drug’s side effects. The familiar tortoise and the hare ads will resume on Sunday, September 14, with lengthened warnings about potential side effects. The extended warnings will occupy 41 seconds of the ad, which will run for 90 seconds – 30 seconds longer than the old ads.
Following the release of the U.S. Food & Drug Administration (FDA) public health advisory on Chantix in May, the Federal Motor Carrier Safety Administration all but outright banned the use of Chantix for commercial drivers.
Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.
A serious skin condition, Stevens-Johnson Syndrome (SJS) can be life-threatening. Cell death causes the outermost layer of the skin (epidermis) to separate from the dermis (skin beneath the epidermis that consists of connective tissue). The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.
Although Stevens-Johnson Syndrome may be caused by viral infections or malignancies, severe allergic reaction to medication is the leading cause.
The connection between Chantix and risk of SJS was highlighted in a recent study conducted by the Institute for Safe Medication Practices (ISMP), which used a combination of Food and Drug Administration (FDA) adverse event reports and pharmaceutical industry Standardized Medical Queries (SMQ) to gather its data.
In the 4th quarter of 2007 Chantix accounted for 998 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.
The results are even more worrisome because FDA adverse event reporting is voluntary for consumers and health professionals, and as a result it is estimated that only 1 to 10 percent of serious adverse events are reported.
Among the series injuries reported were moderate and severe skin reactions. The FDA notes 338 serious events including hives or swelling of the tongue, face, eyes, lips and other areas. An additional 65 reports of severe side effects included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.
Stevens-Johnson Syndrome patients suffer from inflammation of the skin and mucous membranes. Since mucous membranes are present in many organs throughout the body, such as the eyes, digestive system, lungs and respiratory system, many organs can become significantly affected during the disease process. SJS technically is an immune-complex-mediated hypersensitivity (allergic) condition.
SJS typically involves multiple areas of the body and extensive lesion formation. The lesions can extend to the mucous membranes, thus affecting the lungs, eyes, mouth, stomach, intestines and virtually every major organ.
SJS is a serious disorder with potential for severe morbidity and in some cases, it can be fatal. SJS proper (with less than 10 percent of body surface area involved) has the mortality rate of around 5 percent. Other outcomes include organ damage and blindness.
Symptoms
If you have Stevens-Johnson Syndrome, several days before the rash develops, you may experience fever, sore throat, cough, and burning eyes.
Treatment
Stevens-Johnson Syndrome requires hospitalization. Treatment focuses on eliminating the underlying cause, if possible, controlling symptoms and minimizing complications. Recovery after Stevens-Johnson Syndrome can take several weeks to several months, depending on the severity of your condition.
If your doctor determines that your case of Stevens-Johnson Syndrome was caused by medication, be sure to avoid that medication and all others related to it that may cause a similar reaction, because recurrences of Stevens-Johnson syndrome can be fatal.
Rushed through the FDA approval process because of Chantix’s potential to help millions, Chantix was quickly met with increasing scrutiny as one report after another demonstrated the darker side of the drug.
On January 18, 2008, Pfizer updated the Chantix label in the U.S. to include a warning that
Patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.
On February 1, 2008, the FDA issued an Alert on the Safety of Chantix to clarify its findings, noting that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”
On May 21, 2008, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix.
On May 23, 2008, less than 48 hours after Institute for Safe Medication Practices released their report, the Federal Aviation Administration (FAA) banned Chantix use by pilots and air traffic controllers. F.A.A. spokeswoman, Laura Brown, said the decision was based on emerging data on the drug, including a report from a watchdog group, the Institute for Safe Medication Practices, linking Chantix to a wide array of health and safety problems. They include accidents and falls, potentially lethal heart rhythm disturbances, heart attacks, seizures, diabetes and various psychiatric disturbances.
View the full Chantix timeline »
If your loved one has suffered a serious injury or death as a result of a side effect of Chantix, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.
Please contact our Chantix lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.
Chantix, like every drug on the market today, has side effects. You must consider all the facts in order to make an informed decision. Only after careful consideration and discussion with your doctor will you be able to determine if the potential benefit outweighs the risks.
The FDA recently announced that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” The FDA report also stated that product label warnings need to note that Chantix shouldn’t be used while driving, piloting airplanes or operating machinery because it may cause unconsciousness, seizures and hallucinations. Because of this, the FAA has banned Chantix from use by pilots and air traffic controllers.
The FDA received more accounts of serious side effects tied to Chantix in the fourth quarter of 2007 than from any other drug.
On February 1, 2008, the FDA issued an Alert to clarify its findings, noting that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” The FDA report said product label warnings need to note the medication shouldn’t be used while driving, piloting airplanes or operating machinery because it may cause unconsciousness, seizures and hallucinations.
Among the psychological side effects reported to the FDA were 525 reports of hostility or aggression, 397 cases of possible psychosis, 224 reports of heart trouble, 41 cases of homicidal thinking and 28 suicides. There were also 173 serious injuries, including traffic accidents often associated with unconsciousness, dizziness, muscle spasms, or mental confusion, as well as reports of severe skin conditions in patients.
In May 2008 the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix.
If your loved one has suffered a serious injury or death as a result of a side effect of Chantix, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering. Please contact our Chantix lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.
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