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LABEL CHANGES:
The most recently approved FDA precaution on Paxil recommends close monitoring and gradual, rather than, abrupt discontinuation of the antidepressant.
Excerpt from FDA revised label <http://www.baumhedlundlaw.com/media/ssri/paxil/Discontinue.htm> approved on December 14, 2001, "Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paxil is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible."
Karen Barth, one of the lead attorneys representing hundreds of victims suffering dependency/withdrawal syndrome from Paxil states, "Our effort to get the Paxil warning label revised to reflect the truth about the withdrawal problems with Paxil began back in August 2000. That is when we joined attorney Don Farber in filing a lawsuit in an effort to force SmithKline Beecham to revise the label for Paxil. Although the language in the revised label, in our view, should be stronger, we feel the new language is a definite step in the right direction and we feel vindicated in our efforts."
PAXIL WITHDRAWAL LAWSUIT:
January 25, 2002
FOR IMMEDIATE RELEASE
Baum, Hedlund, Aristei, Guilford & Schiavo
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA
Web: www.baumhedlundlaw.com <http://www.baumhedlundlaw.com/>
Los Angeles--17 people who have suffered from severe withdrawal reactions as a result of taking the antidepressant Paxil, filed a lawsuit late yesterday in California Superior Court, LA County, against SmithKline Beecham (SKB). This is the first individual lawsuit (as opposed to class action) that has been filed against SKB by individuals related to Paxil's withdrawal side effects
Class action lawsuits have been cropping up across the country related to Paxil withdrawal ever since attorneys Karen Barth and Mary Schiavo of Baum, Hedlund, Aristei, Guilford & Schiavo, based in Los Angeles, California, and Donald Farber of San Rafael, California, filed their first class action against the drug maker on August 24, 2001.
After filing that lawsuit, the Baum Hedlund and Farber firms were deluged with calls from victims from all over the country. Over 3,000 people contacted Baum Hedlund alone seeking help. The Plaintiffs in this new action come from all walks of life. Of the 17 individually named Plaintiffs, one is a research doctor and another is a pharmacist. The Plaintiffs are individuals who wanted to bring their own individual actions against SKB because of the severity of their withdrawal problems. Most of them continue taking the drug because they have been unable to get off the drug. Some have lost their jobs. Each has experienced similar severe withdrawal reactions and problems such as:
jolting electric "zaps," dizziness, light-headedness, vertigo, in-coordination, gait disturbances, sweating, extreme nausea, vomiting, high fever, abdominal discomfort, flu symptoms, anorexia, diarrhea, agitation, tremulousness, irritability, aggression, sleep disturbance, nightmares, tremor, confusion, memory and concentration difficulties, lethargy, malaise, weakness, fatigue, paraesthesias, ataxia, and/or myalgia.
Paxil was introduced into the U.S. market on December 29, 1992, and is a well-known antidepressant medication in the same class as Zoloft and Prozac (selective serotonin reuptake inhibitors or "SSRIs"). Paxil is approved for marketing in the U.S. for conditions such as depression, obsessive compulsive disorder, panic disorder, and "social anxiety disorder" (often described as "shyness").
On December 14, 2001, the FDA granted SKB's request to be allowed to market Paxil for two new indications, "Generalized Anxiety Disorder" and "Post Traumatic Stress Disorder." However, in addition to the new indications, SKB will be required to provide stronger warnings regarding Paxil's withdrawal problems. For instance, the new label will include language such as:
"Patients should be monitored for these symptoms [dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), agitation, anxiety, nausea, and sweating] when discontinuing treatment, regardless of the indication for which Paxil is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE and ADMINISTRATION)."
Attorney, Karen Barth, stated, "I get outraged every time I see one of SmithKline Beecham's television commercials which states that Paxil is 'non-habit-forming.' SmithKline Beecham walks a fine semantic line and the company knows that this language placates the public concerned with the prospect of taking a drug they might get hooked on. According to the World Health Organization, drug dependence is defined as: 'a need for repeated doses of the drug to feel good or to avoid feeling bad.' (WHO, Lexicon of alcohol and drug terms, 1994.) That is exactly what our clients suffer."
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