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The Truth Behind Paxil’s Black Box

Jan 1, 2008 | Parker Waichman LLP

In "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial", by Alison Bass, Bass details the deception and fraud by companies, doctors, and public officials involving Paxil and its serous side effects.  

In  Bass' story, Paxil—Big Drug—is at the heart of a tale that includes Big Pharma, which uses Big Money to urge Big Slick University Doctor  tomassage Big Drug trial data results while the Food & Drug Administration (FDA), partly funded Big Pharma, ignores everything.  Big Pharma is GlaxoSmithKline, Big Money includes an $800,000 research grant, and Big Slick University Doctor is Martin Keller of Brown University.

Paxil has long been known to cause suicidal thoughts in some children and causes more than just suicidal ideation in others, leading to suicide.  This was discovered in a clinical trial; however, the information was suppressed.  Glaxo continues to market Paxil, but a few insiders talked and, now, every prescription of every antidepressant must carry a black-box warning stating that these types of medications increase the risk of suicidal thinking and behavior in depressed children and adolescents.  As part of a settlement of a lawsuit brought by the attorney general of New York, Glaxo was required to disclose all results, including negative ones results, of all clinical drug trials.  Also, Congress has extended the mandate to the clinical trials of all drug makers.

Paxil also has a long history of difficult withdrawal side effects, causing patients to remain addicted to the drug.  As a matter-of-fact the British drug agency required Glaxo to remove a statement on its patient label saying it was not addictive.  Withdrawal effects are experienced just hours after a missed dose and include a "flu-like" syndrome, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audio hallucinations/illusions, insomnia, nausea, restlessness, "electrical shock" phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colors and stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, "over-reacting", ringing in ears and throbbing in head, vomiting, paranoia, aggressive behavior, roller-coaster emotions, out of character behavior, severe malaise, general dysphoria, derealization, and panic attacks.

A study linked these drugs to an increased risk of death among patients with coronary artery disease and the FDA is strengthening its warning for Paxil because it may be associated with birth defects, citing a study that found increased risk of fetuses developing heart defects.  The FDA asked Glaxo to reclassify Paxil, generically known as Paroxetine, as a "Category D" drug for pregnant women, which means that studies in pregnant women have shown a risk to the fetus.  The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.


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