Reports of Gunman’s Use of Antidepressant Renew Debate Over Side Effects

Fuente: New York Times 

Steven P. Kazmierczak stopped taking Prozac before he shot to death five Northern Illinois University students and himself, his girlfriend said Sunday in a remark likely to fuel the debate over the risks and benefits of drug treatment for emotional problems.

.Over the years, the antidepressant Prozac and its cousins, including Paxil and Zoloft, have been linked to suicide and violence in hundreds of patients. Tens of millions of people have taken them, and doctors say it is almost impossible to tell whether the spasms of violence stem in part from drug reactions or the underlying illnesses.

“It’s a real chicken-and-egg sort of situation,” said Dr. Jane E. Garland, director of the Mood and Anxiety Disorders Clinic at BC Children’s Hospital in Vancouver, British Columbia.

Dr. Garland said some people could and did become agitated and unpredictable in response to the drugs, usually just after starting to take them or soon after stopping.

“But it’s hard to make a case for a withdrawal reaction here, because Prozac comes out of the system gradually,” she said.

The girlfriend, Jessica Baty, said in an interview on CNN that Mr. Kazmierczak took Prozac to battle anxiety and compulsive behavior but that it “made him feel like a zombie and lazy.”

She said that in the days leading up to the shooting he was not behaving erratically, as university officials had suggested.

Much of the debate over the side effects of antidepressants focuses on erratic behavior like the cautious college student who stabs herself or the good husband and father who buys a gun and shoots himself.

The drug labels warn about agitation and severe restlessness, and display a prominent caution that the medications increase the risk of suicidal thinking and behavior in some children and young adults.

Psychiatrists said Monday that stopping an antidepressant could cause effects like lightheadedness, nausea and agitation as the brain adjusted. Among the most commonly prescribed drugs, Prozac is the least likely to cause withdrawal effects because it stays in the system longest, the doctors said.

“A small dose of Prozac is what you might use to block withdrawal symptoms when you take a patient off one of the other drugs,” said Dr. Donald Klein, an emeritus professor of psychiatry at Columbia who has consulted with drug companies.

Sara Bostock, of Atherton, Calif., whose daughter committed suicide shortly after taking Paxil, acknowledged that the interaction between drug effects and underlying emotional distress was hard to untangle.

Ms. Bostock wrote in an e-mail message, “As an observer and suicide survivor, my main wish is that medical professionals, regulatory authorities and other scientists will examine closely the entire medical and treatment history of the perpetrators of these violent incidents in which innocent people are victims.”

She is a founder of ssristories.com, a Web site that has tallied 2,000 news reports of violent acts in which people were thought to be taking antidepressants or had recently stopped them.

“If it weren’t for us, many of these stories would be lost to oblivion forever,” Ms. Bostock said.

Psychiatrists say the debate on such side effects, particularly suicide in the last four years, has driven many patients from drugs that could help save their lives. The psychiatrists emphasize that patients should be closely monitored for changes in behavior when starting or tapering off a medication.

Advocates on both sides agree that catalogs of violent acts are not enough and that news reports are incomplete. Only more thorough investigation and careful tracking of drug side effects, they say, will clarify the links between drug treatment and violent behavior.

Dr. Michael Stone, a professor of clinical psychiatry at Columbia, maintains a database of 1,000 violent crimes, including mass murders, going back decades. In many cases the accused had stopped taking drugs for schizophrenia, Dr. Stone said.

“I only have a handful of cases,” he added, “where the person was on an antidepressant.”

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    — FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries   

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NEWS

 

Food, Medical Product Safety Among Key FY ‘O9 FDA Budget Requests

FDA is requesting nearly $2.4 billion as part of the president’s fiscal year (FY) 2009 budget—a 5.7 percent increase over the current fiscal year budget. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html

 

Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use

FDA has alerted health care professionals about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent).

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

 

FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries

FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The device  

is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to a narrowed section of a coronary artery through a long, thin catheter. When the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01787.html

 

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First Watch

Top

Vitamin D Not Associated with Overall Cancer Mortality

Serum vitamin D levels are not associated with overall cancer mortality, although high levels may be linked to reduced mortality from colorectal cancer in particular, reports the Journal of the National Cancer Institute.

Using data from NHANES III, researchers examined the association between baseline levels of serum 25(OH)D and cancer mortality during a median follow-up of about 9 years. Nearly 17,000 people aged 17 or older were included.

After multivariable adjustment, vitamin D was not associated with overall cancer mortality — a finding that held true in analyses stratified by sex and ethnicity. However, when site-specific cancers were evaluated, colorectal cancer mortality decreased significantly as vitamin D level increased.

Editorialists conclude: “While vitamin D may well have multiple benefits beyond bone, health professionals and the public should not in a rush to judgment assume that vitamin D is a magic bullet and consume high amounts of vitamin D.”

JNCI article (Free abstract; full text requires subscription)

JNCI editorial (Free)

Related Journal Watch link(s):

Physician’s First Watch coverage of a study showing a link between vitamin D supplementation and reduced all-cause mortality (Free)

Top

Washing Surfaces in Hospitals Reduces Spread of MRSA

Basic hospital cleaning should take a higher priority if infections like methicillin-resistant Staphylococcus aureus are to be brought under control, concludes a review published online in Lancet Infectious Diseases.

The author, looking back on studies examining the epidemiology of MRSA and other staph infections, finds the organisms to be long-lived, even when not colonizing patients or their caregivers. She points to the profusion of electronic gear at the bedside, all offering hand-touch sites from which MRSA can spread. Infection-control recommendations, including those from the CDC, stress visible cleanliness as a performance criterion, even though less than half of the “visibly clean” wards were microbiologically clean.

Recommending more spending for cleaning, she concludes: “We do not yet know exactly what impact cleaning could have on control, but this ignorance should not be used as an excuse for doing nothing.”

Lancet Infectious Diseases article (Free abstract; full text requires subscription)

CDC report on managing multidrug-resistant organisms in healthcare settings (Free PDF)