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.

marketed as a super drug to save people from smoking addiction, Chantix is now under increasing scrutiny for its dangerous side effects

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.

the trouble with Chantix

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 »

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.

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.

approved by the FDA in May 2006 as a smoking cessation drug, problems quickly arose

In May 2006, The FDA Approves New Drug for Smoking Cessation the FDA approved Chantix as a smoking cessation drug to help smokers ages 18 and older stop smoking. The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months.

On September 24, 2007, a CBS TV affiliate in Dallas-Fort Worth ran a story titled Chantix: Miracle drug or dangerous problem? after a well-known local musician was killed in an incident believed to be related to erratic behavior associated with Chantix.

On November 20, 2007, Early Communication About an Ongoing Safety Review FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

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.

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.

the following documents outline the trouble facing Pfizer’s Chantix

The FDA Approves New Drug for Smoking Cessation
FDA Consumer magazine | July-August 2006
In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking. The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months, says Curt Rosebrough, M.D., M.P.H., deputy director of the FDA’s Office of Drug Evaluation II.

Early Communication About an Ongoing Safety Review
FDA Alert | November 20, 2007
FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product. The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites.

Pfizer Statement on Chantix (varenicline) Labeling Update in the United States
Pfizer Press Release | January 18, 2008
Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today 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.

FDA Issues Public Health Advisory on Chantix
FDA News | February 1, 2008
The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chatix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

Strong Safety Signal Seen for New Chantix Risks
The Instutitute for Safe Medication Practices | May 21, 2008
A strong signal of multiple safety problems with Chantix (varenicline), a drug to help people stop smoking, has been seen in a pilot program to identify new drug risks in adverse drug events reported to the U.S. Food and Drug Administration. Varenicline is suspected in various adverse drug event reports of causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm distrubances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.

FAA - Anti-Smoking Medicine Chantix Banned
Federal Aviation Administration news release | May 23, 2008
Less than 48 hours after FAA learned the anti-smoking medicine Chantix might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. The agency took this swift action after a medical safety group, the Institute for Safe Medicine Practices, released the results of a study this week that found evidence for the occurence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.

Chantix official full prescribing information
Pfizer official Chantix web site | currently
Official Chantix full prescribing information provided by Pfizer on Chantix web site.

FDA MedWatch reporting form
FDA MedWatch | currently
If you have had an adverse reaction to Chantix or any other prescription medication, the FDA asks you to submit a voluntary report through its FDA Safety Information and Adverse Event Reporting Program. Use this form for voluntary reporting of adverse events, product problems and product use errors.

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.

According to an article published by Bloomberg news service, a recent review of voluntary adverse event reports associated with Pfizer’s stop-smoking drug Chantix reveals more than 3,000 reports of serious side effects in the U.S. alone. Among problems cited by the nonprofit Institute for Safe Medication Practices, which conducted the study, are suicide, heart trouble and aggression.

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