ANTI DEPRESSANT DRUG BLOG

Two Large Studies Show Decline In Suicide Attempts With Antidepressant Treatment

July 11, 2007

Patients with depression treated in two independent health care systems experienced overall drops in suicide attempts between the month prior to starting treatment with antidepressant medications and the month after treatment began.

The findings are based on records from a large prepaid health plan and from Veterans Health Administration databases, reflecting the clinical care of more than 330,000 patients. These two studies are reported in the July issue of the American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association.

The first study, “Suicide Attempts Among Patients Starting Depression Treatment with Medications or Psychotherapy,” is presented by Gregory Simon, M.D., M.P.H., and James Savarino, Ph.D., of Group Health Cooperative-a mixed-model prepaid health plan with approximately 500,000 members in Washington State and Idaho.

Among the 109,256 members treated for depression between 1996 and 2005, suicide attempts decreased during the first month of treatment and diminished further in subsequent months. This progressive decline occurred for both patients taking medication and those receiving psychotherapy. About 60 percent of the treatment episodes began with antidepressant prescriptions and about 40 percent began with psychotherapy visits.

The second study, involving veterans, is described in “The Relationship Between Antidepressants and Suicide: Results of Analysis of the Veterans Health Administration Datasets,” by Robert Gibbons, Ph.D., Kwan Hur, Ph.D., J. John Mann, M.D., and colleagues at the University of Illinois at Chicago and the New York State Psychiatric Institute. The findings are based on 226,866 veterans diagnosed with depression during 2003-2004. The analysis, in addition to showing a decrease in suicide attempts once treatment began, also revealed a lower rate of suicide attempts in depressed veterans who took antidepressants compared to those who did not.

Selective serotonin reuptake inhibitors (SSRIs) were the most commonly prescribed antidepressants, and the rate of suicide attempts for patients taking SSRIs fell from 221 per 100,000 patients before treatment, to 123 per 100,000 after treatment began. The rate also fell after the beginning of treatment with medications known as non-serotonergic and tricyclic antidepressants.

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The positive overall outcomes in the two studies were shared by the youngest patients. The adolescents and young adults studied by Simon and Savarino made approximately twice as many suicide attempts as the total group, but they showed a similar decline after beginning treatment.

Gibbons et al. found that all age groups, including 18 to 25 year olds, experienced both a decline in suicide attempts with treatment and a lower incidence among depressed veterans receiving SSRIs, compared to those receiving no antidepressant treatment.

The authors point out that large-scale studies do not exclude the possibility that depression treatment may precipitate suicidal thinking or behavior in vulnerable individuals.

The findings are reviewed in an editorial by David Brent, M.D., of the University of Pittsburgh.

AJP Editor in Chief Robert Freedman, M.D., stated “These studies of treatment in actual clinical practice find a decrease in suicide attempts after treatment, regardless of whether the treatment is psychotherapy or drug therapy. Patients and their doctors are concerned because of the FDA’s black-box warning that antidepressants can cause suicide attempts. The studies in this issue provide more evidence that this side effect is rare, compared to the overall decrease in suicide attempts that occurs when treatment is initiated. Furthermore, suicide attempts in the first month of treatment occur regardless of whether the treatment is psychotherapy or drug therapy, which suggests that these attempts are part of the natural evolution of symptoms in depression itself.”

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Antidepressant drug type affects bones, study shows

July 9, 2007

Popular antidepressant drugs such as Paxil and Zoloft seem to make users’ bones more porous, perhaps raising the risk of a broken hip or spine fracture, two new studies show.

The research, published in the current Archives of Internal Medicine, looked at thousands of older men and women, including many Portland-area residents studied at Oregon Health & Science University. Tests showed hip and lower spine bones were notably less dense in the subjects that use a kind of antidepressant called a selective serotonin reuptake inhibitor, or SSRI, than in people who used other antidepressants or no depression drugs.

The studies did not count bone fractures, a major cause of sickness and death in the elderly, but bone loss is considered a warning sign that fractures are more likely. The amount of bone lost with SSRI use looks similar to the amount lost by users of certain steroids, drugs that have been linked to osteoporosis and more fractures.

“The magnitude of the bone loss is important” with SSRIs, said Dr. Elizabeth Haney, an OHSU scientist who worked on both papers. “We were surprised by that.”

Doctors say the findings are not a reason to stop using SSRIs, especially if you already take them.

“These drugs have been quite helpful in the treatment of depression,” said Dr. Thomas Dodson, president of the Oregon Psychiatric Association. “We are really concerned that people not overreact and come off their medication” before talking the issue over with their doctor.

But doctors and patients should be aware of the risks SSRIs bring. For instance, older people may need bone-density tests if they use SSRIs for more than several months, said Dr. Kenneth Saag, a University of Alabama at Birmingham bone and joint specialist who did not work on the studies. Fracture-prone people taking SSRIs might also consider building their bones through exercise, taking calcium and vitamin D or asking a doctor about bone-strengthening drugs.

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Antidepressants are the most-prescribed drugs in the United States, according to IMS Health, with 227.3 million prescriptions dispensed in 2006: enough to give every adult in the country a bottle. More than 60 percent of those prescriptions are for SSRIs.

The bone findings add to a growing list of side effects linked to SSRIs. Other studies indicate the pills might increase the risk of suicidal thoughts, especially in children, and may increase the risk for some birth defects if pregnant women take them — both ideas still debated by doctors and scientists. The drugs also have some more common and less potentially serious side effects including weight changes and sexual problems.

Still, SSRIs are considered safer than older depression drugs, especially tricyclic antidepressants such as Elavil. So SSRIs “are still the medication class that are preferred” for depression, Saag said.

Scientists have looked more closely at bones and SSRIs after OHSU’s Dr. Michael Bliziotes published a 2001 paper showing that proteins in bone cells interact with serotonin, a body chemical that also affects mood. When scientists gave mice SSRIs, they formed bone more slowly. In January, a Canadian study showed adults older than 50 who used SSRIs were twice as likely as others to break a bone. With the two new studies, “there is a mounting body of evidence to suggest a relationship” between bone loss and SSRIs, Saag said.

But the case is not proved, Haney said. No one knows just what serotonin does to bone cells. And depression itself seems to make people more likely to break bones. That could be because depression affects the bones directly or perhaps because depressed people often lose weight and get less exercise. Scientists aren’t sure.

“Patients receiving SSRIs are likely different in a number of ways from those who do not take them — in terms of nutrition, exercise, etc.,” said Oregon Osteoporosis Center Director Dr. Michael McClung, who was not connected to the studies. “Whether SSRIs cause the difference in bone mineral density or whether something else (like the severity of depression) results in both bone loss and in the choice of SSRI as the antidepressant cannot be ruled out.”

Haney said bone changes during SSRI need to be tracked more closely to prove the link. She also hopes to look again at the older people she studied, to check fracture rates and SSRI use. Many factors besides bone density can contribute to fractures, including bone shape, exercise, strength and good balance.

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Antidepressant Warnings Associated With Decreased Prescription Rates Among Tennessee Children

July 5, 2007

Antidepressant medications are frequently used to treat depression among children and teens, but in 2003 data emerged regarding an increased risk of suicidal thinking and behavior among young patients taking these drugs, according to background information in the article. “In December 2003, the Committee on Safety of Medicines [the U.K. drug regulatory agency] declared the risk-benefit profile of all selective serotonin reuptake inhibitor (SSRI) antidepressants (as well as venlafaxine hydrochloride and mirtazapine), with the exception of fluoxetine, to be unfavorable for the treatment of major depressive disorders in children and adolescents,” the authors write. “Shortly thereafter in 2004, the Food and Drug Administration convened a Psychopharmacology Advisory Committee meeting in February, issued a public health advisory in March, and in October required black box warning labels for all antidepressants (including fluoxetine) highlighting the potential increase in suicidal thinking and behavior in children and adolescents. The warning recommended more intense therapeutic monitoring to mitigate these risks but did not suggest avoiding the pediatric use of antidepressants.”

Benji T. Kurian, M.D., M.P.H., and colleagues at Vanderbilt University School of Medicine, Nashville, Tenn., examined monthly antidepressant prescription data among patients age 2 to 17 years covered by the TennCare expanded Medicare program. “The study included the 45 months from Jan. 1, 2002, through Sept. 30, 2005, 12 months following the FDA black box warning,” the authors write. “The study months were divided into two periods. The period before the regulatory warnings included the 24 months from Jan. 1, 2002, through Dec. 31, 2003, and that after the regulatory warnings included the 21 months from Jan. 1, 2004, through Sept. 30, 2005.” An average of 405,000 children and teens qualified for the study each month.

During the period before the regulatory warnings, there was little change from month to month in the rate of new antidepressant prescriptions, with an average of 23 per 10,000 patients. By the end of the study–a total of 21 months after the U.K. warnings–this proportion had decreased by 33 percent to an average of 15 per 10,000 per month.

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The decrease was most pronounced for SSRIs (except for fluoxetine) and another type of antidepressant linked to suicidal thoughts and behaviors, selective norepinephrine reuptake inhibitors. New users of fluoxetine, the only antidepressant approved by the FDA for the treatment of depression in children and adolescents, increased by 60 percent. “However, there was no evidence of an increase in discontinuations of therapy with antidepressant or other psychotropic drugs, which suggests that the primary effect of the warnings was to alter the decision to treat a newly presenting patient,” the authors write.

Previous studies have shown that the use of antidepressants among TennCare patients is similar to that of children and adolescents in the entire United States, suggesting that a similar decrease may have occurred in other populations. Because there is so much uncertainly regarding the pediatric use of antidepressants, the implications of these changes are unclear, the authors note. “Thus, while it is now evident that regulatory interventions can alter patterns of practice, whether this is desirable is uncertain,” they conclude. “There is an urgent need for better data on the efficacy and safety of antidepressants to guide pediatric practice.”

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Antidepressants Not Big Risk for Defects

July 2, 2007

Newborns face little risk of birth defects from antidepressants taken by many women early in pregnancy, say the reassuring findings of the two biggest studies of this controversial link.

The research focuses on the class of drugs chosen most often for depression and anxiety, including the brands Prozac, Paxil and Zoloft.

Paxil carries a warning of possible heart defects in newborns, and experts don’t expect the new research to change that. However, they find the new studies comforting for women struggling with depression.

The possibility of birth defects from antidepressants has put doctors and patients in a tricky quandary. Birth defects obviously hurt newborns, but depressed mothers who can’t give proper care also endanger their babies.

Confusing matters, researchers have wondered if the concern about birth defects should extend beyond Paxil to this entire class of drugs, known as selective serotonin-reuptake inhibitors, or SSRIs. The two latest studies, appearing Thursday in The New England Journal of Medicine, relieve some of that worry, say birth specialists.

“Yeah, there’s a risk, but the risk overall is probably pretty small,” said Dr. Susan Ramin, obstetrics chairman at the University of Texas Medical School in Houston, who was familiar with the findings.

The two studies , one from the federal Centers for Disease Control and the other from Boston University , use more cases of birth defects than previous research to consider links between the abnormalities and SSRIs. The Boston University study was funded partly by the National Institutes of Health and Paxil maker GlaxoSmithKline PLC.

Together, the two studies looked at 19,471 newborns with birth defects and 9,952 without them. Then they considered what SSRIs the mothers in both groups took during the first three months of pregnancy and mapped the patterns of birth defects.

Neither study was able to tie SSRIs as a group to either heart defects or most other defects. That reassurance is especially welcome because depressed women fret even more than other mothers about the health of their newborns, said Dr. Stephan Quentzel, a psychiatrist who treats pregnant women at Beth Israel Medical Center in New York City.

Also, a mother’s untreated depression can lead to poor care or turmoil at home, a weaker maternal bond, and other problems for a newborn. “The fetus and the newborn are almost always worse off if the mom is depressed than if … exposed to the vast majority of antidepressants,” Quentzel said.

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However, doctors and mothers have been very wary about medications and birth defects since Europe’s thalidomide scandal of deformed babies in the 1960s. Defects from all causes are expected in about 3 percent of births, enough to make many mothers nervous.

The concern about SSRIs grew out of GlaxoSmithKline’s own alert in 2005 about possible heart defects in newborns whose mothers took Paxil early in pregnancy. The U.S. Food and Drug Administration added its own warning. Last year, a separate study linked SSRIs taken late in pregnancy to a lung disorder in newborns.

The latest studies do not consider that disorder, known as persistent pulmonary hypertension. But they suggest that the risk of other defects from an SSRI , even if confirmed , would add only a fraction of 1 percent to the overall danger, researchers said.

Paxil did appear to triple the risk of a defect in blood flow from the heart, both studies found. But that additional danger would still be modest, experts said.

The studies further hinted at possible ties between other SSRIs and a handful of other defects, but researchers said the numbers of newborns with specific defects were too small to draw strong conclusions.

“Based on these studies, it’s correct to say: no major risk,” said Carol Louik, a public health expert who led the Boston study. “I wouldn’t say, ‘No risk.’”

Researchers said women should talk over the potential risks and benefits with their doctors, preferably before pregnancy.

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Antidepressant studies find low birth-defect risk

June 29, 2007

Use of antidepressants by pregnant women doesn’t significantly increase the risk of birth defects, with rare exceptions, two studies found.

The overall risk of having a child with a defect increased by less than 1 percent in women on the drugs, including Pfizer Inc.’s Zoloft, GlaxoSmithKline PLC’s Paxil and Forest Laboratories Inc.’s Celexa, according to research published today in The New England Journal of Medicine.

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As many as one in five pregnant women has symptoms of depression, according to the American Pregnancy Association, a Texas-based nonprofit organization. Depression can lead to premature birth or low-birth-weight babies, and researchers say women need to balance risks and benefits with their doctors in deciding whether to seek treatment with antidepressants.

“If everyone decides that treatment for depression is appropriate and needed during pregnancy, the overall message from this is relatively reassuring,” Michael Greene, director of obstetrics at Massachusetts General Hospital in Boston, said yesterday. He wrote an accompanying editorial in the journal.

Individually, Paxil was tied in one of the studies to a defect that affects blood flow to the lungs, while Zoloft was linked to two rare disorders involving defects in the baby’s intestines and heart chambers.

Margaret Spinelli, an assistant professor at Columbia University College of Physicians and Surgeons in New York, said that while the new research may make doctors more cautious in prescribing antidepressants, pregnant women with serious depression will still need treatment.

“If the risk of being on a medicine is relatively safer than the illness itself, you are more likely to choose the medication,” she said yesterday.

Public health expert Carol Louik, lead author of one study, said: “It’s important to keep in perspective that the absolute risks are relatively small. It’s a very difficult thing to prove safety. The best we can really do is place an upper bound on what the risk might be.”

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Paxil and Birth Defects: I Blamed Myself for Too Long

June 25, 2007

Shae was prescribed Paxil at the beginning of 2000 for anxiety. She was also taking the birth control pill at the time, so her pregnancy came as quite a surprise. But she stopped taking the drug as soon as she found out. “My doctor told me I was carrying twins but test results only showed one heartbeat,” says Shae. “He said the other baby was still there and everything was okay.” That couldn’t have been further from the truth.

paxil baby”I went for an ultrasound and everything appeared normal but I had this funny feeling — she wasn’t moving like my first baby. At 30 weeks, they realized that something was wrong so at 32 weeks I had an in-depth ultrasound. At that point, my ‘perfectly normal’ baby wasn’t perfect or normal. In fact, my doctor told me that I shouldn’t have carried her past the first trimester — I should have lost her when I lost her twin.

‘Be prepared for her to be still-born or to die right after birth,’ he said. I had six weeks of trying to come to terms with this before she was due, and hoping beyond hope that the tests were wrong.

I had to carry her to term — my waters broke at 40 weeks to the day. Once she was born the room was silent — she was terribly deformed. She had no muscle, all her bones were broken, she had a cleft palate, she couldn’t even open her eyes. Brighid was born paralyzed and couldn’t swallow her fluid. It was awful.

We decided on no heroics — there wouldn’t be any quality of life for her. That was the saddest hour of my life.

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And having to explain to my two-year-old that she would never see her sister, the sister she was so excited about. Now I had to explain to my daughter that her sister wasn’t coming home. (And there was so much fear she went through when I was pregnant again.)

We had an autopsy and they explained that certain levels of development happened and others didn’t, like she was pieced together. They couldn’t give us a reason why this happened and they said it could happen again. I was terrified. I did have another baby but my pregnancy was monitored very closely and we had genetic counseling beforehand. I mentioned to my doctors that I had been on Paxil but nothing was said…

A short time ago I was getting my email and reading the news online and I came across an article about a woman whose child was born with Pierre Robin Sequence (PRS) and she had taken Paxil during her pregnancy. Brighid had the same secondary characteristics — such as cleft palate and small lower jaw. I looked up Paxil and birth defects.

Ohmigod, seeing these stories was like reliving this nightmare all over again.

A huge part of my life has been taken away from me, not only losing my daughter but I was so afraid after my third was born that I ended up having a tubal ligation. I have a new partner but we won’t be able to have kids together.

I wasn’t angry at my doctor — he hadn’t a clue about Paxil’s side effects back then. I was so angry at the drugmaker; I blamed myself for so long. Then I came across your website and figured if what happened to my daughter matched up to what happened to other children, I want to know. And I want others to know.

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Health: Finding The Right Antidepressant

June 21, 2007

In health, the effort of figuring out which medications will work best for patients with the help of some mind reading. Medical Reporter Stephanie Stahl has the details.

We’re talking about antidepressants, which are taken by millions of Americans.

Finding the right one can be a long and frustrating process but now there could be a new solution.

There wasn’t much smelling the flowers for June Govinden, like millions of Americans she suffered from depression.

“I couldn’t stop crying so that was the last for me, that was the final thing that I’ve got to try something,” June said.

Antidepressants can help, but finding the right one can be a process of trial and error. A drug that works for one patient may not work for another.

“It can be very discouraging for a patient to get the message that we are not really sure if you are going to get well on this medication,” Dr. Andrew Leuchter said.

It can take six weeks before doctors know if an antidepressant is working. But researchers may have discovered a major shortcut by reading a patient’s mind.

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It’s called EEG, with a few painless electrodes the machine records brain waves.

Just days after a new medication is started, scientists look for subtle differences in electrical activity.

Dr. Leuchter is leading the nationwide study and works with the company that makes the device.

“We can tell by the changes that occur within the first few days of drug treatment whether the brain is responding in such a way that the patient will eventually get better,” Dr. Leuchter explained.

Preliminary results are promising and if that continues, EEGE could become a valuable tool.

“If it works, it’s great because you could tailor make your treatment program to the patient,” Dr. Charles Goodstein of the New York School of Medicine said.

The EEG technology is still being tested and there’s no telling if or when it could be widely used.

For now, it’s best to work with your doctor to find the best antidepressant.

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Pittman ruling upheld

June 13, 2007

COLUMBIA — The S.C. Supreme Court has upheld the murder conviction of Christopher Pittman, the Chester County teenager who claimed antidepressants led him to kill his grandparents and set their house on fire when he was 12.
The court ruled Monday against several arguments made by Pittman’s attorneys, including the contention that he was denied a speedy trial before he was sentenced to 30 years in prison in February 2005. He was 15 at the time of his sentencing.

Three years earlier, he shot his grandparents, Joe and Joy Pittman, with a pump-action shotgun as they slept, then set fire to their home in Chester County.

His attorneys argued unsuccessfully that he had been involuntarily intoxicated by the antidepressant Zoloft at the time of the shooting and didn’t know right from wrong. In appealing, his attorneys said the trial judge should have used a different standard for jurors to determine involuntary intoxication.

“We had very high hopes,” said Del Duprey, Pittman’s maternal grandmother who lives in Wildwood, Fla. “We feel like once more, South Carolina has let him down. We felt we really had some excellent points.”

Duprey said the family would appeal to the U.S. Supreme Court, which would need to decide to hear the case. Paul Waldner, one of Pittman’s attorneys, also said the legal fight will press on.

“Obviously, the decision is a setback for us, but our resolve to continue to try to obtain justice for this boy who committed the only violent act of his life only days after he was given a mind-altering drug is strong,” Waldner said.

Pittman began taking antidepressants after he attempted to hurt himself with a knife and run away from home while living in Florida, according to court documents.

He continued taking the antidepressant after moving in with his grandparents in Chester County, where he was later accused of trying to choke a second-grader, court documents state. On the night of the murders, he had been disciplined by his grandfather for misbehaving at choir practice, according to the documents.

Prosecutor Barney Giese could not be reached Monday.

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Pittman called his grandmother on Monday morning after the ruling came out. The two spoke for about 10 minutes.

“He let me know that he was doing OK,” Duprey said. “He sounded very good. I think he had not allowed himself to be confident there would be any change.”

The case generated outrage that Pittman was held so long before his trial. In October, dozens of supporters and relatives gathered in Columbia as defense attorney Andy Vickery argued before the state Supreme Court that his client’s confession was influenced by Zoloft and his youth.

Pfizer Inc., the manufacturer of Zoloft, has said the drug “didn’t cause his problems, nor did the medication drive him to commit murder.”

Zoloft is the most widely prescribed antidepressant in the country.

Even before Monday’s ruling, Pittman and his lawyers faced long odds, says Yale Zamore, the Chester County public defender who was Pittman’s lawyer until 2004.

“This is the sort of thing I was afraid would happen right from the beginning,” Zamore said. “I describe this as a high-wire act with no net. Once you’re knocked over, the game is over.”

Pittman’s life in prison

Still, Pittman’s supporters say they will forge ahead. Some plan to go to Washington, D.C., this month to attend FDA hearings on antidepressants.

“We’re thinking he just tried to put a good spin on it,” said Mike Maloney of Rock Hill, a technical illustrator who closely follows the case and talked to Pittman on Monday. “He claims it’s kind of what he expected. But of course, he has more time to dwell on these things than we do.”

Pittman, now 6-foot-2, turned 18 in April. Friends and family visit him at prison in Columbia to talk, play cards and share snacks. The visits are limited to four hours.

Pittman particularly enjoys hearing about his older sister, Danielle, who has a baby girl and is expecting a second child in November. Mostly, he reminisces about his days before prison.

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Depression drugs may raise bone risks

June 13, 2007

Older women who take certain antidepressants are at increased risk of fracturing a bone, but it’s not clear whether the association is due to the drugs, depression itself, or some other factor, according to a report in the Harvard Women’s Health Watch.

Nevertheless, while women shouldn’t stop taking antidepressant drugs for the sole reason of protecting their bones, those who suffer from depression should get their bone mineral density checked out, the report’s authors say.

They cite a study published this January in the Archives of Internal Medicine that found women over 50 who were taking selective serotonin reuptake inhibitors, a class of antidepressant drugs that includes Prozac and Zoloft, were twice as likely to suffer fractures compared with their peers who were not taking them.

However, the researchers add, just 137 of the more than 5000 study participants were on the drugs, and these women were also more likely to be taking other drugs that could contribute to bone loss.

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AdvertisementNevertheless, the Harvard newsletter article authors point out that there have been reports since the 1990s linking depression in women, even younger women in whom thinning bones is relatively rare, to lower bone mineral density. One of these studies found depressed women had higher levels of the stress hormone cortisol, which contributes to bone loss.

Another study in animals found depression boosted secretion of another hormone, noradrenalin, which blocks the activity of bone-forming cells. A number of other substances in the body, including leptin, may also be involved in the mental health-bone strength link, the authors say.

Depressed women simply may not eat as well and exercise as much as their non-depressed peers, both of which can lead to bone loss, the authors add.

Dr Jessica Goren, a clinical psychiatric pharmacist at Cambridge Health Alliance, notes that depressed individuals should be informed and counselled on their osteoporosis risk, “because regardless of whether depression is an independent factor, lifestyle is”.

The authors suggest that women who are taking antidepressants discuss the risk of osteoporosis with their doctor and get a bone mineral density test

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Paxil refunds

June 6, 2007

A $64 million class action settlement recently approved by an Illinois judge means parents who bought their kids the antidepressant drug Paxil could be eligible to recoup their out-of-pocket expenses.

The Associated Press reports:

Parents who bought the antidepressant drug Paxil for their children may begin seeking reimbursements under a $64 million class-action deal to settle claims that the drug’s maker misled consumers about the medication’s safety. Under the deal, parents with proof that they bought GlaxoSmithKline PLC’s Paxil and Paxil CR, a controlled-release version of the drug, for their children can recoup out-of-pocket expenses. Parents who no longer have pharmacy records or receipts can get up to $100 refunded by signing a claim form that carries penalties for lying.

Britain-based GlaxoSmithKline denies claims it promoted the drug to children while withholding information about negative side effects, including increased suicidal behavior. Any money left over in the settlement fund is to be returned to GlaxoSmithKline. Anyone with a personal injury claim, including the parents of teenagers who took their own lives while taking Paxil, still can sue GlaxoSmithKline, as can insurers and governmental agencies who actually paid the bulk of the money.

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The settlement does not require GlaxoSmithKline to notify those who may be eligible for reimbursement.
Claim forms have to be filed by Aug. 31.

The FDA warned that an 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. The FDA reported 11 suicide attempts — none resulting in death — among patients given Paxil in the trials. Just one of the patients who took a placebo attempted suicide. Given that small number, the FDA said then, the results ‘‘should be interpreted with caution.’’ All trial patients suffered from psychiatric disorders, including major depression. The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.

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