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Dian Rosier
Dian Rosier
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Mounting Problems with Paxil

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Since 1992, when the FDA first gave its approval for the release of Paxil in the U.S. market, it has been one long rollercoaster ride for the drug manufacturer, GlaxoSmithKline, GSK.

Generating annual sales of up to 2 billion dollars, Paxil has been prescribed for the treatment of depression, and a large variety of other “disorders”, many of which the American public had never heard of before ambitious drug companies began aggressive advertising campaigns to market their newest money maker.

Undoubtedly profitable, the drug has also been plagued with controversy is increasingly the subject of litigation resulting from warnings issued too late for many of its hapless victims.

Paxil is one of a group of antidepressants known as selective serotonin reuptake inhibitors or SSRI’s that has been marketed throughout the world and has been the subject of great controversy and multiple lawsuits. GSK has been called to task because of its failure to advise the public and medical professionals of numerous studies that indicated problems with the prescription drug long before the FDA stepped in repeatedly to force cautionary labeling.

Studies funded by the drug companies themselves indicated as early as 2000, that patients taking SSRI’s were five and a half times more likely to deliberately and violently harm themselves than those taking tricyclic antidepressants.

In December of 2005, the FDA issued a public health advisory about new studies showing that women who took Paxil in the first trimester were one and a half to two times more at risk to have heart related birth defects.

In February of 2006, the New England Journal of Medicine reported that babies exposed to SSRI’s in the last trimester were 6 times more at risk of developing Persistent Pulmonary Hypertension of the Newborn (PPHN) than unexposed infants. PPHN is a life threatening lung condition caused when the blood vessels do not dilate.

Often, the public has been kept in the dark about the side effects of these drugs until litigation brings it to light.

According to a study printed in the Journal of Clinical Psychiatry (June 2005), 75% of scripts for SSRI’s written by health care providers are for “off label” use or treatments not approved by the FDA. Congress is currently investigating this practice of promoting off label drug usage by the pharmaceutical companies.

Lewis Morris, Chief Counsel at the Department of Health and Human Services’ Office of Inspector General, testified before a US House Committee on Oversight and Government Reform in February 2007, “Off-label promotion fundamentally circumvents the FDA drug approval process, on which Americans rely to evaluate the safety and efficacy of pharmaceutical products.”

In a world where we are constantly confronted with what can seem like too much information, we, as patients, often rely completely on the advice of our health care providers. When those providers are seduced into experimenting with our health and the health of our unborn children by prescribing medications based solely on suggested uses that have not been thoroughly tested, it is past time to stand up and change the way things work.