Suicide warning issued for young Paxil users
WASHINGTON (AP) — The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned Friday in a letter to doctors.
The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.
A recent analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.
The FDA reported that there were 11 suicide attempts — none resulting in death — among the patients who received Paxil in the trials. Just one of the dummy pill patients attempted suicide.
Given that small number, the results “should be interpreted with caution,” the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.
GlaxoSmithKline released its findings after the FDA asked antidepressant manufacturers examine their clinical trial data for any links between the drugs and suicide in adults, company spokeswoman Mary Anne Rhyne said.
“At some point, the FDA is going to say what their analysis shows across the category,” Rhyne said, adding of her company’s own analysis: “We felt like this was information we wanted to share with physicians.”
In the letter to doctors, Dr. John E. Kraus, the company’s director of clinical development for clinical psychiatry in North America, said GlaxoSmithKline PLC continues to believe the drug’s benefits outweigh its risks.
The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.
In 2004, the FDA ordered strong warnings about the pediatric risk of suicidal tendencies put on antidepressant labels, and began analyzing whether adults face a similar risk.
All antidepressants now carry warnings on their labels cautioning patients and doctors of the risk of suicidal behavior.
Courtesy of CNN – read full story here.
Mountain Rose Herbs is where we recommend you purchase all of your organic, wild crafted bulk herbs, spices, teas and pure,organic essential oils!
Would you like to learn the healing art of Aromatherapy, Color/Crystal Therapy or Reflexology? Become an Aromatherapy Practitioner, Color, Crystal Practitioner, or a practitioner of Reflexology through the certification home study and distance-learning courses at Alternative Healing Academy!
Learn more about Xtend-Life – Micro-Nutriments – The elite of natural supplements. Love life, Live Longer!
For Guaranteed, Effective, 100% Natural Herbal Remedies , please visit Native Remedies
Are you looking for quality vitamins, diet aids and health supplements? Visit the Health Supplement Shop – highly recommended by NHH!
Your Free PDF Health Ebook...
Natural Help for Senility
Simply Right Click and choose Save As to save to your desktop! More FREE Natural Health, Wellness and Pet Ebooks at Remedies4.com!
Leave a Reply