October 26

FDA approves Paxil for Premenstrual cramps

FDA approves Paxil for Premenstrual cramps

Wed, 3 Sep 2003

On September 2, the FDA approved Paxil (Seroxat) for yet another newly invented “condition.” Inasmuch as those most likely to complain about premenstrual discomfort which has been labeled, premenstrual dysphoric disorder (PMDD)–are likely to be pubescent girls, FDA’s approval is bizarre.

Following disclosure that children and adolescents given Paxil in the manufacturer’s own controlled clinical trials, the suicide rate was between twice and three times the rate of those given a placebo, FDA announced an investigation of the clinical trial data from all pediatric trials of Paxil and the other SSRI antidepressants– such as, Prozac, Zoloft, Celexa, Effexor.

Approval of PMDD is bizarre given the renewed debate and growing concern about the safety and effectiveness of SSRIs. Indeed, the New York Times reported that 7 of the 10 experts who served on FDA’s panel of experts in 1991, said that given the evidence, they would reverse their original decision clearing SSRIs to suicide. Dr. Jeffery Lieberman, a leading psychopharmacologist who served on FDA’s panel told the Times on August 7:

“In 1991, we said there wasn’t sufficient evidence to support a link between these drugs and suicide. Now there is evidence, at least in children, and I wouldn’t rule out that it’s in adults too.”

In its June 18, 2003, “Dear Doctor” letter to physicians in the UK, GlaxoSmithKline acknowledged that Paxil, poses serious risks of suicide and severe drug withdrawal symptoms for children under 18. See: https://ahrp.org/risks/PaxilRisks0603.php

“In studies that used a tapered withdrawal regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine [Paxil] at a frequency of at least 2% of patients that occurred at a rate that was at least twice that of placebo were: nervousness, dizziness, nausea, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide) and abdominal pain.”

If the safety of SSRI Antidepressants for children is under investigation by the FDA, then what is the FDA’s justification for expanding the use of Paxil by adolescent girls, when this drug has been banned in the UK and Canada for children under eighteen?

New drugs / indications

FDA Approves Paxil CR (Paroxetine) for Treatment of Premenstrual Dysphoric Disorder

PHILADELPHIA, PA — September 2, 2003 — GlaxoSmithKline (NYSE: GSK) today announced the U.S. Food and Drug Administration (FDA) approved Paxil CR™ (paroxetine HCl) Controlled-Release Tablets as the first controlled-release medication for the treatment of premenstrual dysphoric disorder, a condition affecting three to eight percent of women of reproductive age in the United States. Premenstrual dysphoric disorder (PMDD) is characterized by intense emotional symptoms including irritability, tension, and depressed mood as well as physical symptoms associated with the menstrual cycle. Paxil CR is also indicated for the treatment of depression and panic disorder.

“As a clinician, I have seen first hand how debilitating PMDD can be for women in their lives and in their relationships with family, friends and co-workers,” said Kimberly A. Yonkers, M.D., Associate Professor of Psychiatry, Yale University of Medicine and lead investigator of the largest clinical trial database of PMDD patients. “Today’s approval of Paxil CR provides physicians and patients with a new treatment option that effectively manages PMDD symptoms at the lowest available dose.”

Premenstrual Dysphoric Disorder (PMDD)

Affecting over 5 million women of reproductive age in the U.S., PMDD is not just a new name for premenstrual syndrome (PMS). PMDD is a severe form of PMS that can significantly impair a woman’s ability to carry out daily activities both professionally and personally.

PMDD symptoms commonly emerge in the second half of the menstrual cycle and subside when menstruation begins or shortly thereafter. The symptoms follow this pattern every month or almost every month. Knowing PMDD symptoms is a critical element in the appropriate diagnosis and treatment of the condition.

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