FDA Panel Concurs Fluoxetine Effective For PMDD

Fluoxetine could gotten the first drug okayed specifically for premenstrual dysphoric disorder, the severe signifier of premenstrual syndrome that is gauged to touch on 3%-5% of regularly menstruating adult females.

The Nutrient and Drug Disposal's Psychopharmacologic Drugs Advisory Committee unanimously concorded that the data exhibited by Eli Lilly & Co., the drug's manufacturer, rendered enough evidence to propose that fluoxetine is safe and effective when utilised to treat adult females with premenstrual dysphoric disorder (PMDD).

Their ballotings on efficaciousness, however, were go withed by several cautions, reflecting uncomfortableness with the quality of some data.

Usually, a company designings and deals surveys for a new drug or indicant in close audience with the FDA. But in this suit, the three surveys of fluoxetine for PMDD were investigator-initiated and patronised by Lilly. The company filed the application for the PMDD indicant after the surveys held been dealt.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

If okayed for this indicant, Lilly trusts to marketplace the selective serotonin reuptake inhibitor (SSRI) under a name other than Prozac because marketplace research shows adult females with PMDD may attach a stigma to that name and be reluctant to take the drug.

Fluoxetine was the first SSRI okayed for depression and has since been okayed for obsessive-compulsive disorder, binge-eating syndrome, and gerontologies depression.

At the hearing, Lilly exhibited the upshots of three double-blind surveys of adult females with PMDD; these compared the consequences of 20 mg or 60 mg of fluoxetine daily vs. placebo. Survey participants were handled for up to 6 months.

The largest survey, dealt in Canada, entered about 300 adult females over the age of 18 with regular menstrual rhythms who come acrossed the diagnostic standards for PMDD; the bulk were white and were in their mid-to late 30s.

Those handled with fluoxetine held significant diminutions in all three symptom clusterings that qualify PMDD, compared with placebo: mood symptoms (dysphoria, irritability, and latent hostility); physical symptoms (bloating and breast tenderness); and social impairment. These improvements were seen in the first round and were kept throughout the 6-month survey, according to Dr. Rajinder Magistrate, manager of Lilly Neurosciences, Indianapolis.

Responses to the larger fluoxetine dose were slightly higher than those obtained with the lower dose but not significantly so.

In an interview at the hearing, the survey's pb author, Dr. Meir Steiner of McMaster University in Hamilton, Ont., gauged that fluoxetine works in about 60%-70% of adult females with PMDD.

The other two surveys were smaller and less well contrived than his. One also rendered evidence that 20-mg and 60-mg doses of fluoxetine were significantly better than placebo; in the third survey, 20 mg of fluoxetine was more effective in reducing PMDD symptoms than the antidepressant bupropion (Wellbutrin), which held an outcome similar to placebo.

The side consequences detected in the three trials were comparable with the known side-outcome profile of the drug.

Because the lower dose was better stood than the 60-mg dose, the company is recommending a daily dose of 20 mg, although some patients may gain from increasing the dose to 60 mg, Dr. Magistrate stated.

Adult females on OCs were leave outed from the surveys, to avoid any possible consequences OCs held on mood. But there is no clinical evidence, including extensive postmarketing surveillance, that concomitant usage of OCs "augments or lessens the efficaciousness of fluoxetine," she added.

Since the onset of PMDD symptoms is cyclical and extremely predictable, an intermittent dosing agenda is being explored as an option treatment, which would bring down exposure to the drug. Anecdotal evidence advises this may be effective, but the jeopardies of treatment are uncertain at this point. Lilly is conducting two large multinational surveys in which adult females get down treatment on day 14 of their round until the onset of menstruation.

Robert M. Hamer, Ph.D., of the department of psychological medicine at Robert Woods Johnson Medical exam School in Piscataway, N.J., emphasised that ob.gyns. and other primary tending dr.s, who will be the most likely to order fluoxetine for PMDD, should be careful to tell PMDD from rapid cycling disorder, which can be exasperated with fluoxerine treatment.

The pathophysiology of PMDD is not fully understood. The most plausible theory is founded on the observation that cyclic alterations in ovarian steroids "cause dramatic alterations in the encephalon neurotransmitter scheme," including alterations in serotonin, according to Jean Endicott, Ph.D., a well-known PMDD expert at Columbia river University New York. She was at the hearing as a advisor to Lilly

There have been more than 30 printed surveys of fluoxetine and other serotinergic agents in adult females with PMDD or PMS, and the bulk have bumped positive upshots with treatment, she stated.

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Prepackaged bars do battle with PMS

It's not as if chocolate needs a boost among women who crave it while pre-menstrual. But now, savvy manufacturers are seizing on the association and marketing products that play up the connection between PMS relief and a fix of chocolatey goodness.

Canadian vitamin and health product manufacturer Jamieson Laboratories is the latest, with its PMS Support Chocolate Bars. In addition to chocolate, the 14-gram bars are laced with natural botanicals, including white willow bark extract, which is purported to be a natural pain reliever, artichoke leaf extract, which acts like a diuretic, and chasteberry extract, said to reduce the irritability, depression and bloating associated with pre-menstrual syndrome.

Each dark chocolate bar is 70 calories and the recommended dose is three bars a day for up to five days. A package of 15 bars is about $20.

"This is not convenience-store chocolate," says Jamieson spokesman John Challinor.

An American company called Ecco Bella is selling a similar product, the Women's Wonder Bar, which it claims will soothe and alleviate the symptoms of PMS and menopause thanks to such ingredients as flaxseed, chasteberry and rose essential oil.

While the natural supplements market has been somewhat stagnant in recent years, with 43 per cent of Canadians taking vitamins and minerals daily, Mr. Challinor says it is starting to expand again as the population grows and ages.

"More and more, you find natural supplements have a role to play in preventative health," he says.

Robert Reid, a PMS researcher at Queen's University, says he knows of one paper suggesting a "modest benefit" from chasteberry extract, but asks: "Who would think to mix it with 10 other ingredients to come up with a tasty treat?"

Anything with chocolate that works for PMS or premenstrual dysphoric disorder (PMDD) would be popular, says Dr. Reid, but advises women not to forget that manufacturers of non-medicinal products can make any claims they like.

Premenstrual syndrome is the name given to a group of symptoms that can occur one to two weeks before the start of a woman's menstrual period - everything from bloating and abdominal pain to irritability and anxiety. Premenstrual dysphoric disorder is a more severe expression of those symptoms.

Mr. Challinor says that in the two weeks since the product has been on sale, the feedback has been positive, if anecdotal.

His wife and daughter have given the product a thumb's up.

"If it works for them, it works for me," he says.


PMDD Gets Recognized in TV Commercial

I just saw this commercial yesterday. It discusses PMDD and some birth control called YAZ. Maybe PMDD will become more familiar to others because of this commercial and that would be a good thing. Whenever I tell my friends about my PMDD, they say they have never heard of it.


Gene May Help Spur Premenstrual Depression

MONDAY, July 23 (HealthDay News) -- Scientists have discovered a gene variant linked to an increased risk of severe premenstrual depression.

Premenstrual dysphoric disorder, or PMDD, is a psychiatric condition that affects about 8 percent of women in their childbearing years. Women with PMDD experience bouts of major depression and/or anxiety and severe irritability during the second half of their menstrual cycle. These symptoms subside with the onset of the menstrual period.

PMDD has been thought to be related to hormonal changes over the course of the menstrual cycle.

For a new study published online June 30 in Biological Psychiatry, researchers studied 91 women with a confirmed diagnosis of PMDD over at least three months. Another 56 women who had no history of mood disorders related to the menstrual cycle served as the comparison group.

The team found four specific gene variants in the estrogen receptor alpha gene, ESR1, that were more common in the women with PMDD than in the control group.

"While these are preliminary findings that require replication in larger studies, we would argue that this may explain part of the variance among women in the susceptibility to developing this mood disorder," the study's senior author David R. Rubinow, Meymandi distinguished professor and chair of psychiatry at the University of North Carolina School of Medicine, said in a prepared statement.

How to eliminate suffering from PMS in 5 simple steps...