Paxil Warning and Update

Every day you hear warnings associated with many prescription drugs to notify your physician if you have “thoughts of suicide,” after taking a new medicine. This warning did not exist for Chris and many others back in 2002. Below is a history of Paxil and what it took for GlaxoSmithKline to publish such a warning.

FDA Finally Issues Warning Too Late For Many

2 May 2006:   The Associated Press reported today that GlaxoSmithKline and the FDA warned in a letter to doctors that the antidepressant Paxil increases the risk of suicidal behavior in young adults between ages 18 and 30.  USA Today article: The FDA has determined that Paxil increases the risk of suicide in young adults.

(If the previous link fails you can find the article here: (Click Here )

Too Late For Chris and His Family

Sadly, Chris was one of the many for whom the warning was too late to help. In the early morning hours of September 6, 2002, after reaching his lifelong dream by signing a recording contract with RCA, and just one year after being prescribed Paxil, Chris crashed his car into a utility pole and died in a matter of minutes. He was 29. In the fall of 2001, Chris began taking Paxil. In the months following, he began to experience severe depression, insomnia, violent “waking nightmares,” inexplicable feelings of aggression, and thoughts of suicide. By July of 2002, Chris began to exhibit signs of suicidal behavior.

Time Line Of Culpability

The following is a time line establishing the culpability of GlaxoSmithKline – the makers of Paxil – in Chris’ death, and in the deaths and suffering of countless others.

December 1992:  Paxil is introduced in the U.S. market.  From it’s inception, medical researchers throughout the world documented Paxil’s propensity for dependence/withdrawal symptoms when patients attempted to reduce or discontinue taking Paxil. These observations have been published in an abundance of peer reviewed medical journal articles.   Baum, Hedlund, Aristei, Guilford & Schiavo (Paxil Litigation Update June 19, 2003).

1 May 1997:  SmithKline Beecham issued a sales memo:  A vivid reminder of the importance of Paxil to GlaxoSmithKline is found in a 1997 sales memo where sales reps are reminded, “Let’s face it in the end. [sic] The only thing the anxious and agitated patient will be saying is: ‘Where’s my Paxil!!!!!!'”  The comment is illustrated by a cartoon of a screaming woman at the bottom of page 2 of the memo.

September 1997:  In an internal sales document GlaxoSmithKline graphically explains the importance of Paxil to the company. The discontinuation of use of the drug Paxil would cost the company BILLIONS.  This statement is illustrated by a large, black money bag.

24 August 2001:  The first case brought against GlaxoSmithKline was filed as a nationwide class action by 35 named plaintiffs.

December 2001: GlaxoSmithKline was required by the FDA to revise its Paxil label to acknowledge that the drug can cause withdrawal reactions. Despite the label modification, GlaxoSmithKline’s television advertisements and promotional brochures continued to contradict the new label and further mislead consumers and doctors about whether Paxil can cause severe withdrawal symptoms.

23 July 2002:  Paxil manufacturer Glaxo-Smith-Kline (GSK) secretly settled its appeal of the ruling in the Paxil trial last year. (Original Post Now Inactive: http://www.namiscc.org/Advocacy/2002/Summer/GSK-SettlesPaxilTrialAppeal.htm)

16 August 2002:  The judge in the case granted the plaintiff’s motion and ordered GlaxoSmithKline to pull its television ads claiming that Paxil may cause mild temporary side effects, but Paxil is not associated with dependency addiction and is not habit forming.  Within two days, the FDA stepped in to argue that the Court did not have jurisdiction to disallow GlaxoSmithKline to air the commercials.  Our government at work to protect us.

16 October 2002: Paxil is Forever!  (Original Post Now Inactive http://citypages.com/databank/23/1141/article10788.asp) Article by Beth Hawkins, in the St Paul, Minnesota “City News”. In a  year of tumbling stock prices, accounting scandals, and shaky consumer spending, the British pharmaceutical giant GlaxoSmithKline has had remarkably good news to report so far… Paxil!  However, the bad news for those taking the drug is they may never get off of it.  Paxil is Forever!

9 June 2003:  The United Kingdom banned the use of Paxil for treatment of  children and adolescents.

18 June 2003:  Nine days after the United Kingdom ban, the FDA announced that Paxil should not be prescribed for children and adolescents under age 18 in the U.S.

5 April  2004:  Reported this date – FDA Congressional investigations underway re. FDA’s failure to protect public health.

“The position taken by the FDA (and broadly disseminated in the national media) about its request that antidepressant drug makers warn of a suicide risk in adults and children, has been that, even though it has requested this warning, such a risk might not actually exist. These public statements are contrary to the findings of the FDA’s own scientists who have concluded otherwise. Indeed, the FDA has suppressed these findings and engaged a group from Columbia University to second-guess the clinical judgment of the original clinical trial researchers and even the FDA’s own scientists.” Baum Hedlund

2 June 2004:  The State of New York sues GlaxoSmithKline.  The lawsuit alleged that information was intentionally withheld about Paxil, and that data involving its safety in children and adolescents was misrepresented.

December 2004:  “This is about money,” said Rep. Henry Waxman, D-Calif., member of a congressional committee investigating antidepressant manufacturers. “This is not about science, because what they’re doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits.”

9 December 2004:  ABC News uncovered documents that suggest GlaxoSmithKline failed to disclose information about the possibility of an increased risk of suicidal behavior in children taking Paxil, as well as serious withdrawal  symptoms in some patients when they stop taking Paxil. A recent survey shows that as many as 75% of doctors are unaware that Paxil causes dependency/withdrawal syndrome. (Original post now inactive http://paxillawsuit.lawinfo.com/paxil-class-action-lawsuit.html)

July 2005:  The FDA published an Alert Suicidal Thoughts or Actions in Children and Adults. “Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.”  Note: This alert seems to soften the the announcement made 2 and 1/2 years earlier.  See above.

22 August 2005:  New Your (Cnn/Money) – Paxil, a blockbuster antidepressant from British drug maker GlaxoSmithKline, increases the risk of suicide in adults, according to a study by Norwegian researchers.

12 May 2006:  GlaxoSmithKline and the FDA warn in a letter to doctors that Paxil increases the risk of suicide in young adults between the ages of 18 and 30.