antidepressants

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Opinion: Time To Lift The Black Box Warning On Antidepressants

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

By Drs. Steve Schlozman and Gene Beresin
Guest contributors

In 2004, the Food and Drug Administration made the difficult decision to apply a “black box” warning to virtually all antidepressant medications.

A few months earlier, British health officials had issued a similar warning for paroxetine, or Paxil, a frequently used antidepressant. Both the United States and the United Kingdom were worried about the possibility of antidepressant use in some people causing an increase in agitated, and even suicidal, behavior. The warnings, still in effect, apply particularly to adolescents.

But recent research suggests that perhaps the black box warning should itself have a black box warning. A new Harvard study suggests the warning has actually led to an increase in suicides because it caused a decrease in the treatment of depression through antidepressant prescriptions. Similar studies published back in 2007 showed a fairly dramatic increase in suicide attempts by adolescents, corresponding to a decrease in prescriptions for antidepressants. The Harvard study is a reiteration of these previous findings.

We believe it is time for the black box warning to be lifted. And we suspect that bias and ignorance may play a role in the fact that it has not been.

First, some background information.

A “black box warning” is a written message that by U.S. law must accompany every prescription for which the warning is indicated. Continue reading

Doctor: Possible Links Between Antidepressants, Pregnancy And Autism

By Dr. Adam Urato
Guest Contributor

On Friday, a new study was released in the British Medical Journal showing that antidepressant use during pregnancy is associated with autism in the exposed children. This is now the second study within the last two years showing this link and it adds to the accumulating evidence of potential harm associated with the use of antidepressants during pregnancy.

Adam Urato, M.D., a maternal-fetal medicine specialist says evidence is growing on the harms of taking antidepressants during pregnancy.

Adam Urato, M.D., a maternal-fetal medicine specialist says evidence is growing on the potential harms of taking antidepressants during pregnancy.

The study was a case-control study from Sweden, which was fairly large: it looked at 4,429 cases of autism spectrum disorder and compared these cases to 43,277 matched controls. The researchers found that antidepressant use during pregnancy, with either SSRIs or nonselective monoamine reuptake inhibitors (another type of antidepressant) was associated with an increased rate of autism spectrum disorders in the offspring. The odds ratio was high at 3.34, which roughly means that antidepressant use was associated with more than a tripling of risk of autism in the children.

The study concludes:

In utero exposure to both SSRIs and non-selective monoamine reuptake inhibitors (tricyclic antidepressants) was associated with an increased risk of autism spectrum disorders, particularly without intellectual disability. Whether this association is causal or reflects the risk of autism with severe depression during pregnancy requires further research. However, assuming causality, antidepressant use during pregnancy is unlikely to have contributed significantly towards the dramatic increase in observed prevalence of autism spectrum disorders as it explained less than 1% of cases.

These results do not surprise those of us who have been following the scientific studies in this area over the past two decades. Continue reading

Prescription Nation: 4 Billion A Year, Antipsychotics Lead Psych Meds


To share these mind-boggling (and I use the term advisedly, because so many of these drugs act on the mind) statistics, I’m passing along a press release just in from the American Chemical Society in full:

People in the United States took more prescription drugs than ever last year, with the number of prescriptions increasing from 3.99 billion (with a cost of $308.6 billion) in 2010 to 4.02 billion (with a cost of $319.9 billion) in 2011. Those numbers and others appear in an annual profile of top prescription medicines published in the journal ACS Chemical Neuroscience.

Journal Editor-in-Chief Craig W. Lindsley analyzed data on 2011 drugs with a focus on medications for central nervous system (CNS) disorders. So-called antipsychotic medicines — including those used to treat schizophrenia, bipolar disorder, obsessive-compulsive disorder, Tourette syndrome and some forms of depression — ranked as the fifth most-prescribed class of drugs by sales. Antidepressants, for conditions that include depression and anxiety, ranked No. 7.

XanaxTM, CelexaTM and ZoloftTM were the most-prescribed psychiatric medicines, with other depression and anxiety medications rounding out the top 10. Two antipsychotics were among the 10 drugs that Americans spent the most on, with AbilifyTM in fourth place. Lindsley explains that while antidepressants continued to be the most-prescribed class of CNS drugs in 2011, prescriptions for ADHD medicines increased by 17 percent and multiple sclerosis medications by 22.5 percent in sales from 2010. While expiring patents on major antipsychotics in the next few years will put pressure on drug makers to innovate, the industry should be heartened by the growth of the number of prescriptions and spending.

The full paper is here, including this chart of the top 10 drugs:

Top 10 drugs

Top 10 drugs in 2011 (Source: IMS Health via ACS Chemical Neuroscience)

Commentary: Considering Medication When You’re Pregnant And Depressed

Orit Avni-Barron, M.D.

By Orit Avni-Barron, MD
Guest Contributor

Pregnancy is not child’s play. Morning sickness, varicose veins and not-fitting-into-your-jeans aside, the constant awareness of everything that can go wrong during pregnancy is often overwhelming. Throw depression or anxiety into the mix, and things can quickly go south.

About one in ten women are prescribed an antidepressant during pregnancy – most often for depression or anxiety but also for other indications like eating disorders. Stigma, fear and lack of knowledge may lead women to stop treatment prematurely (often upon discovery of an unplanned pregnancy). Discontinuing medication, especially when it is done abruptly, can expose women to a host of other problems.

The current information available to women about using antidepressants during pregnancy can be quite confusing. New studies are abundant but difficult to interpret. Media coverage often focuses on horror stories about women suffering with extreme — often untreated — depression and anxiety (think Andrea Yates).

At the same time, TV commercials solicit law suits against prescribers who attempt to treat and prevent such cases. Navigating this mine field is often challenging and even health care providers struggle with making recommendations to their patients. For women, this can result in getting different messages from different providers about the risks and benefits of taking medications while pregnant.

The final decision about treatment ultimately falls on the patient’s shoulders. She is the one who needs to put that pill in her mouth and swallow it. And then she needs to do it again, and again and again. Every day.

This woman may already be compromised by anxiety or depressive symptoms. Or, she may be symptom-free thanks to an antidepressant and scared of the way she might feel off it. Like most women, she probably feels guilty about taking medication during pregnancy. She may be embarrassed about needing treatment, maybe even hide this fact from loved ones. Her partner has an opinion about what she needs to do. Her friends tell her about an esoteric fact they heard about the particular antidepressant she’s taking. She wants to do right by her baby…she can’t tolerate the despair and anxiety.

As a women’s mental health specialist I’ve often witnessed women struggle to find a definitive answer. Continue reading

Study: Antidepressants Increase Risk Of Preterm Birth

pumicehead/flickr

Back in the 1990s, when many of us were still “Listening To Prozac,” there was a flurry of news stories that explored this question: should pregnant women take antidepressants or not?

More specifically, was it better for women with mood disorders taking antidepressants to remain on their medication during pregnancy (to prevent slipping back into depression) or stick to earlier conventional wisdom that all drugs (and alcohol and caffeine and swordfish for that matter) should be forbidden during pregnancy? A number of the stories back then concluded that the risk of an unmedicated, depressed mother was more detrimental to her baby than the possible negative effects antidepressants might have on a developing fetus.

Now the pendulum seems to be swinging back. A new report by researchers at Yale adds to a growing body of evidence that suggests taking such medications during pregnancy can increase the risk of medical problems and complications.

The Yale study found that women who are depressed during pregnancy aren’t at any higher risk of giving birth prematurely compared to non-depressed women. But the researchers did find that women taking antidepressants during pregnancy were at higher risk for what is called a “late” pre-term delivery, between 34 and 37 weeks. The study was published online last week in the journal Epidemiology. It concludes:

Our study adds to a growing body of research suggesting that SRIs during pregnancy may increase a woman’s risk of early delivery. In assessing the implications of this risk for clinical practice, care must be taken to balance the health implications for the mother with those for the fetus.

Continue reading

Is There Now A National Debate Over Antidepressants?

Author Robert Whitaker

Tell me if I’m exaggerating. But I think it’s now fair to say that there’s a rising national debate — at least judging by some of the premiere media outlets — over the value of antidepressants.

Just to update you on the latest posts and ripostes: Dr. Marcia Angell, former editor of the New England Journal of Medicine, wrote a provocative two-part series in The New York Review of Books on three recent books that call into question the current drug-heavy style of psychiatry. Then Dr. Peter Kramer, of “Listening to Prozac” fame, responded in defense of antidepressants in The New York Times on Sunday, July 10.

Now the latest gleanings from Twitter: There’s a petition afoot to get the Times to run a response to Peter Kramer’s piece. The response is by Bob Whitaker, author of “Anatomy of an Epidemic,” who challenges current practices of prescribing psychiatric drugs. (CommonHealth wrote about him here.) As of this morning, the petition had nearly 400 signatures.

Here’s Bob responding on Psychology Today’s blog. He challenges Peter’s arguments in his usual data-driven way, and concludes:

As I noted in Anatomy of An Epidemic, the real problem we have in this field of medicine is that academic psychiatry hasn’t been honest in what it tells the public about psychiatric medications. If the medications are to be used wisely, and in an evidence-based manner, we need to have an honest discussion about what science is telling us about the drugs. But on Sunday, in this essay “In Defense of Antidepressants,” the American public has been treated to yet another dose of misinformation.

Peter Kramer: ‘In Defense of Antidepressants’

Dr. Peter D. Kramer

As we’ve noted here and here, The New York Review of Books just ran a two-part essay by Dr. Marcia Angell, former editor of The New England Journal of Medicine, on the ills of modern American psychiatry, with its heavy reliance on sometimes dubious drugs.

 

Now comes a response, a piece by Dr. Peter Kramer, of “Listening to Prozac” fame, that dominated the front of the SundayReview section in The New York Times. Peter opens with the recent bad press that antidepressants have been getting, including in Marcia’s writing, then asks:

Could this be true? Could drugs that are ingested by one in 10 Americans each year, drugs that have changed the way that mental illness is treated, really be a hoax, a mistake or a concept gone wrong?

This supposition is worrisome. Antidepressants work — ordinarily well, on a par with other medications doctors prescribe. Yes, certain researchers have questioned their efficacy in particular areas — sometimes, I believe, on the basis of shaky data. And yet, the notion that they aren’t effective in general is influencing treatment.

Peter walks the reader through a broad swath of recent research on antidepressants, and writes: Continue reading

Three Recent Warnings On Antidepressants; Latest Is Stroke Risk


As we all know, three of anything makes a trend in journalism, and my trend alarm has just gone off concerning scary news about antidepressants. First, there was this review three weeks ago finding a “modest link” between antidepressants and cancer — though not in studies funded by the drug companies.

Then, author and former Globe staffer Alison Bass reported a week ago on her blog here that a researcher has found that serious flaws tended to skew the biggest study ever of antidepressants toward making the drugs appear more effective than they really are.

And now, Dr. Adam C. Urato, assistant professor of medicine at Tufts, has just sent over the latest: a paper in the current American Journal of Psychiatry that suggests that antidepressants increase the risk of stroke. He emailed:

This is an important study with real public health implications. We have so many patients on these drugs and use seems to be ever-increasing. If they are associated with stroke, as they seem to be, that’s information that patients and the public need to know.
When you combine this type of study showing a risk of stroke like this with the other studies that now show that antidepressants don’t appear to have a clinically significant benefit for most patients with mild to moderate depression (i.e. most users) then you really have to question why so many patients are on these drugs.

I leave it to others to defend antidepressants, but here are the basics on the latest study: It appears in the May edition of the American Journal of Psychiatry. It uses a “case-crossover” design, which aims to identify triggers for events. In this case, the event is a stroke. It included more than 24,000 patients who’d had strokes in Taiwan. The findings:

We found that antidepressant use was associated with a 48% greater risk of stroke, Continue reading

Report: Antidepressants Linked To Cancer Risk — But Not In Industry-Funded Studies

Harvard researchers, analyzing more than 60 studies exploring the potential link between antidepressants and breast or ovarian cancer found a “modest” link indeed exists — but not in studies with funding from the pharmaceutical industry, USA Today reports. The lead researcher, clinical psychologist Lisa Cosgrove of the Edmond. J. Safra Center for Ethics at Harvard, suggests more study is crucial.

In the journal PLos One, Cosgrove reviewed 61 studies of the potential link between antidepressants, some of the most popular drugs prescribed, and breast and ovarian cancers:

Pooling all of the 61 past studies looking for links to antidepressants together, the PLoS One analysis found a modest increase in the odds, roughly an 11% higher chance, of women taking antidepressants developing the diseases later in life. But the odds look worse for women when the researchers pull out from the analysis the 15 studies funded by pharmaceutical industry money, none of which found any link.

“Researchers with industry affiliations were significantly less likely than researchers without those ties to conclude that (antidepressants)s increase the risk of breast or ovarian cancer,” found the analysis. The increased risk effect was particularly stronger for women taking newer, selective-serotonin re-uptake inhibitor drugs (SSRI’s) over older antidepressants. The authors call for more study of the link and Cosgrove suggests that women in their 40’s who take antidepressants may want to discuss getting a mammogram with their doctors, despite 2009 recommendations against the test for their age group.