 PAXIL: New Label WARNING
On May 12, 2006, GlaxoSmithKline (GSK) and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil. These labeling changes relate to adult patients, particularly those who are younger adults.
A recent comprehensive analysis of suicidal behavior and suicidal thoughts was conducted in placebo-controlled clinical trials of Paxil in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults aged 18-30, treated with Paxil compared with placebo. The analysis included 8958 patients treated with Paxil and 5953 patients treated with a placebo.
The frequency of suicidal behavior in adults of all ages with MDD is 228% higher in patients treated with Paxil than placebo. However, since the absolute number and incidents of suicidal events was relatively small (only 2.1% of the total), the FDA told physicians “these data should be interpreted with caution,” meaning, ‘You may continue to prescribe Paxil, just watch out for suicidal behavior.’
The bottom line is that since all of the reported events of suicidal behavior in the adult patients in the FDA’s analysis were non-fatal suicide attempts, the FDA and the drug company simply send out a New WARNING letter to a few health care professionals and hope that the public doesn’t find out.
The truth is millions of Paxil prescriptions have been written for patients suffering from Major Depressive Disorders. Many of these patients have committed suicide while taking Paxil, but the actual number is of deaths due to Paxil vs the patient’s depression is very hard to definitively determine.
Unfortunately, the FDA has become desensitized to the large number of serious side effects due to the drugs they regulate, including death. Twenty years ago when I started my clinical practice as a physician, just one death was sufficient for the FDA to pull a drug off of the market. Today the acceptable limit seems to be 60-90 deaths.
FDA WARNING about PAXIL Inadequate!
In June, 2003 an FDA panel recommended that Paxil be discontinued for children under 18, but to this day no mention of that recommendation has been added to the Drug WARNINGS. The action followed a ban on Paxil by the British Medicines and Healthcare Products Regulatory Agency and an evaluation of the entire class of Selective Serotonin Reuptake Inhibitor antidepressants (SSRI’s), which includes Prozac, Zoloft, and Wellbutrin among others.
An FDA spokeswoman Susan Cruzan told reporters, "The FDA received information from reports in clinical trials in pediatric patients that showed that Paxil in this population is associated with an increased risk of suicidal thinking, and three clinical studies that failed to show that the drug was more effective than placebo," Dr. Cruzan also emphasized that Paxil has never been approved by the FDA for use in children under 18.
WARNING: Suicidality in Children and Adolescents
Antidepressants have been previously been found to increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. The FDA has previously warned physicians:
"Anyone considering the use of PAXIL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL has is not for use in pediatric patients."
"Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials."
According to a lawsuit filed in June of 2004 by New York Attorney General Eliot Spitzer, GlaxoSmithKline PLC committed fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children.
The lawsuit, filed in New York State Supreme Court, said Glaxo suppressed four studies that failed to demonstrate the drug was effective in treating children and adolescents and suggested a possible increase of suicidal thinking and acts.
It also said an internal 1999 Glaxo document showed that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”
So why doesn’t the FDA ban the drug in the US like the British FDA equivalent has done?
The answer could be appallingly simple. Paxil, manufactured by GlaxoSmithKline, is the second-most popular antidepressant in the United States, with $2.5 billion in sales in 2002.
Dr. Hansen's RX: Don't Do Drugs! Drugs are dangerous. They are associated with serious side-effects that are often not discovered during the drug approval process by the FDA. Sometimes the side-effects are not reported until years later. Unfortunately, even though the side effects may include death, more often than not, the FDA merely asks the manufacturer to add a WARNING to the prescribing information, which most patients never read.
If
you are told you need a drug for the treatment of any condition,
you should read the WARNINGS and Side-Effects boxes first
and ask if there is a safer alternative. In most cases
there are natural alternatives that are safer and more
effective. (If you have a question about a drug’s
side-effects or want to know about possible natural alternatives,
please " Ask
Dr. Hansen ") Instead of Paxil, Dr. Hansen prescribes
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If you are currently taking Paxil, you need to know that it is an extremely difficult drug to withdraw from and you should seek the assistance of an understanding and knowledgeable physician to assist you in the process. Some patients have committed suicide months or even years after weaning off of Paxil. The withdrawl effects of Paxil has been reported to persist for years in some patients.
To read the complete FDA May 12, 2006 Safety Summary, including links to the Dear Healthcare Professional Letter, go to FDA’s following link:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil
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