ANTI DEPRESSANT DRUG BLOG

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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Antidepressant does not improve symptoms in advanced cancer patients without major depression

June 5, 2007

Antidepressant sertraline does not improve symptoms, wellbeing or survival in patients with advanced cancer who do not have major depression. The findings are reported early Online - timed to coincide with presentation of the paper at the American Society of Clinical Oncology meeting in Chicago ? and in the July edition of The Lancet Oncology.

Self-ratings of depression, mood, fatigue, and quality of life are significant predictors of survival in patients with advanced cancer. Although the simple explanation for this is that people close to death get very depressed, two previous small randomised trials showed substantial survival benefits with psychological treatments aimed to improve wellbeing. Therefore Dr Martin Stockler, National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Australia, and colleagues assessed the benefit on symptoms and survival of sertraline in patients with advanced cancer but no major depression.

The authors say: ?We postulated that sertraline might improve these features of health-related quality of life and increase overall survival by helping patients to cope better with their illness and treatment.?

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Between 2001 and 2006, the researchers treated 189 patients with advanced cancer with 50mg sertraline each day, or placebo. They found that patients receiving sertraline experienced no significant effect on depression, anxiety, fatigue, wellbeing or quality of life. Their findings suggest the overmedicalisation (giving drugs to patients where the benefit is unclear or unproven) of patients with advanced cancer should be avoided.

However, the authors stress that sertraline use should continue in situations where it is of proven benefit ? such as patients with advanced cancer who have major depression.

They conclude: ?Treatment with a selective serotonin reuptake inhibitor [antidepressant] should be reserved for those with a proven indication.?

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