The side effects of Paxil, a popular prescribed anti-depressant drug, are well known. They include insomnia, anxiety, seizures, hallucinations and suicidal thoughts.
Paxil withdrawal is a clinically recognized condition for those wishing to stop taking the drug; it’s called Paxil withdrawal syndrome and is known to be the most severe withdrawal for drugs in its class. It includes nightmares, nausea, dizziness, nervous anxiety and uncontrollable crying.
The frequency of suicidal thoughts and actual suicides found amongst adults Paxil taking has been so apparent that is was advised that children, adolescents and young adults not take this drug at all.
Back in 2003 reports began to appear of teenagers committing suicide while on Paxil. The FDA looked over a test of the drug. They found of the 93 Paxil patients in this group, 10 attempted suicide or thought about it compared to only 1 out of 87 patients given a placebo.
This led to an FDA demand in 2004 that a black box warning label be put on this drug stating the increased risk of suicidal thoughts in teens taking it. (In 2003, theUKandIrelandhad totally banned the use of Paxil , which was called Seroxat in those countries, by any person under18 years of age due to this suicide risk.)
How can it be that children and teens in theUSAare still being subjected to the side effects of Paxil? Or to Paxil withdrawal syndrome when trying to get off the drug?
The answer lies inUSlaw. It is not illegal to prescribe Paxil to someone under 18 even though the FDA has not approved the drug for that age group. A doctor can prescribe Paxil if the physician or pharmacist accepts liability and warns the patient and parents of the side effects and the risk of suicidal thoughts or actions.
However, it is illegal for the manufacturers of these drugs to advertise or promote such “off-label” use of their drug for children under 18 years old.
When the FDA approved Eli Lily’s antidepressant Prozac as safe for children under 12, GlaxoSmithKline, the maker of Paxil realized their road to riches was disturbed since the FDA had not deemed their product safe for kids while approving a drug made by their competition.
GlaxoSmithKline’s solution was to cheat.
The US Dept of Justice website describes that drug company’s scheme. In July of 2012 there was a $3 billion health-care fraud settlement against GlaxoSmithKline – the largest amount inU.S.history.
GlaxoSmithKline had unlawfully promoted Paxil to treat patients under age 18 without FDA approval.
They prepared, published and distributed a misleading medical journal article to pediatricians that misrepresented the drug’s benefits.
They buried two other studies that showed the drug didn’t work.
And, they sponsored dinners, lunches, spa treatments, and other activities to promote Paxil to doctors as a drug for children.
The mainstream media described GlaxoSmithKline’s actions less conservatively and included more details from the court proceedings.
Fox Business News writer Al Lewis in an article called “How to Sell Drugs to Children” wrote, that GlaxoSmithKline “promoted Paxil for unapproved uses by bringing top-prescribing psychiatrists to lavish resorts.
“The meetings were held at expensive resorts such as the El Conquistador Resort & Golden Door Spa inPuerto Rico, the Rio Mar Beach Resort inHawaii, and the Renaissance Esmeralda Resort & Spa inPalm Springs, Calif. GSK paid for the psychiatrists’ lodging, air fare, and a $750 honorarium. GSK paid speakers a $2,500 honorarium. GSK also paid spouses’ airfare.
“GSK hosted nice dinners…and paid for entertainment, including sailing, snorkeling, tours (e.g. the Bacardi rum distillery), golf, deep sea fishing, rafting, glass-bottomed boat rides, and balloon rides.”
On the surface it looks like this lawsuit will help protect children from Paxil.
Will there be no more Paxil side effects and suicides?
Well, technically Paxil in theUnited Statesis still not banned for kids under 18 as it is in theUKand it can still be prescribed by physicians.
It’s not certain that the $3 billion dollar loss has created a sobering effect.
According to GlaxoSmithKline’s press release explaining the lawsuits to its shareholders, it seems taxes are in their favor and “the net effect of these movements on total earnings is expected to be neutral.”
And, sadly, none of this settlement money goes directly to families who have suffered the ill effects of Paxil in their households.
To date, the discredited scientific study on Paxil has not been retracted from the professional literature in the Journal of the American Academy of Child and Adolescent Psychiatry.
Its lead author Martin Keller quietly retired fromBrownUniversitybut retains the title of emeritus professor of psychiatry and human behavior. Apparently the University hopes the issue will fade away. However, Dr. Jon Jureidini, who has written papers that debunk the bogus study praising Paxil, is requesting the currentBrownU.president take action against Keller and he has some support from another doctor who is an associate professor of medicine at Brown.
It seems clear that money not health care has been the motivation behind Paxil. Neither adults nor children should be subject to side effects of Paxil or Paxil withdrawal.
GlaxoSmithKline states its purpose to be “improving the quality of human life by enabling people to do more, feel better and live longer.” The corporation should take this Paxil case as an opportunity to do some soul searching and purge their product list of drugs that do the opposite of what their motto states.