Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Among the serious side effects reported from Chantix (varenicline) use is Stevens-Johnson Syndrome (SJS).

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 4^th 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.

About SJS

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

• Facial swelling
• Tongue swelling
• Hives
• Skin pain
• A red or purple skin rash that spreads
• Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
• Shedding (sloughing) of your skin

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.

According to a report in today’s Stars & Stripes, a daily newspaper published for the U.S. military, Department of Defense (DoD) civilians, contractors and their families, the anti-smoking medication Chantix (varenicline) has been pulled from at least one military pharmacy following reports of serious adverse reactions.

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while most Chantix side effects are mild, there is new information linking Chantix to more serious side effects

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.

most common Chantix side effects

• nausea
• sleep disturbance
• constipation
• flatulence
• vomiting

more serious Chantix side effects

• severe allergic reactions
• nightmares
• insomnia
• depression
• suicidal thoughts
• Stevens-Johnson Syndrome (SJS)
• hepatitis
• liver failure

Do you have a Chantix claim?

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.

recent studies link Chantix to suicide, homicidal thinking, heart trouble, diabetes, stevens-johnson syndrome and liver failure

Our defective drug and product liability lawyers work solely on behalf of individual plaintiffs that were injured by defective products, such as heparin.

Over the past 29 years, we have successfully handled thousands of defective drug claims, having recovered more than $20 billion in verdicts and settlements for our clients.

Chad Cook is the heparin lawyer investigating claims on behalf of the firm.

Do you have a Chantix claim?

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.