just an fyi...Anti-depressant drugs can double risk of gastrointestinal bleeding

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http://www.eurekalert.org/pub_releases/2007-10/wfub-adc100807.php

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release date: 8-Oct-2007

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Wake Forest University

Baptist Medical Center

Anti-depressant drugs can double risk of gastrointestinal bleeding

WINSTON-SALEM, N.C. – New research shows that selective serotonin

reuptake inhibitors (SSRIs), a group of drugs commonly used to treat

depression, may double the risk of gastrointestinal bleeding, according to

researchers from Wake Forest University School of Medicine and colleagues. When

the drugs are taken with aspirin and other similar pain medications, the risk

is more than 600 percent higher.

“Clinicians who prescribe these medications should be aware of the

potential risk and may need to consider alternatives,” said Sonal Singh,

M.D., senior researcher and an assistant professor of internal medicine.

“In addition, regulatory authorities should consider revising existing

package inserts to highlight the magnitude of the risk.”

The research was reported online this month in Alimentary Pharmacology

& Therapeutics. Emerging evidence has shown that SSRIs may be

associated with bleeding of the lining of the digestive tract including the

esophagus, stomach or upper part of the small intestine, which together are

called the upper gastrointestinal (GI) tract. Upper gastrointestinal bleeding

may be potentially serious and require hospitalization for blood transfusions

and other treatments.

The drugs are widely used to treat depression, panic disorder and

obsessive-compulsive disorder. The researchers undertook the study because of a

lack of information on the exact magnitude of the risk. They also looked at the

effects of taking SSRIs at the same time as non-steroidal anti-inflammatory

drugs (NSAIDs), which are also associated with upper GI bleeding. NSAIDs

include prescription medications such as Celebrex® and over-the-counter drugs

such as aspirin and Aleve®.

The researchers pooled data from four studies involving 153,000 patients,

which allowed them to detect effects that might not show up in the individual

studies. They found patients taking SSRIs were nearly twice as likely to

develop upper GI bleeding than patients not taking the drugs. When the patients

also took NSAIDs, the risk of upper gastrointestinal bleeding was six times

higher than in patients taking neither medication.

The authors said the combined use of NSAIDs and SSRIs may have a synergistic

effect, which results in the elevated risk of bleeding beyond that seen with

each agent alone.

“While the risk to an individual may increase by only a small amount,

the impact to the general population is likely to be substantial because of the

large numbers of people who use these drugs,” said Singh.

He said that depressed, older adults may be most vulnerable because they are

more likely to have conditions such as osteoarthritis that require the use of

NSAIDs.

Based on their findings, the authors estimate that for every 411 patients

over age 50 taking SSRIs, one is likely to develop upper GI bleeding requiring

hospital admission. In patients taking both SSRIs and NSAIDs, one out of 82

would be expected to develop the problem.

“We estimate that roughly 18,000 additional cases of upper GI bleeding

occurred in the United States and United Kingdom in 2003 as a result of taking

SSRIs,” said Singh.

In addition to the clinical studies, the researchers analyzed 101 reports on

adverse effects submitted to the Canadian Adverse Events Database and the U.S.

Food and Drug Administration’s Adverse Event Reporting System. They found

that bleeding associated with SSRI use occurred after a median of 25 weeks on

the drugs. About 67 percent of those patients were also taking NSAIDs. The

adverse reaction was not limited to the elderly, with 38 percent of cases

occurring in patients below the age of 60.

“These findings emphasize the importance of clinicians taking a

detailed gastrointestinal history from patients and targeting the use of SSRIs

to patients who are at relatively low risk for upper GI bleeding,” said

Singh.

The research did not distinguish between specific drugs and whether one was

associated with more bleeding than another. However, previous studies have

shown that paroxetine (Paxil®), sertraline (Zoloft®) and fluoxetine (Prozac®)

are most often associated with abnormal bleeding. Singh said future research

should address the question of which specific drugs and combinations of drugs

are associated with the highest risk.

Singh’s co-researchers were Apurva Trivedi, M.D., with Wake Forest,

and Yoon K. Loke, M.D., lead author, with the University of East Anglia,

Norwich, United Kingdom.

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Wake Forest University Baptist Medical Center is an academic health system

comprised of North Carolina Baptist Hospital and Wake Forest University Health

Sciences, which operates the university’s School of Medicine. The system

comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds

and is consistently ranked as one of “America’s Best

Hospitals” by U.S. News & World Report.