A January 2008 study published in the New England Journal of Medicine reveals that nearly one-third of studies conducted on antidepressant drugs are not published. Nearly all of the unpublished studies show that the drugs being tested didn’t work. In addition, some of the studies on antidepressants that were published spun unfavorable results to make the drugs appear more effective than they really were.

The United States Food and Drug Administration (FDA) does not require companies to publish all data on clinical trials or to make those trials publicly available. However, “[s]elective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health,” wrote the authors of the study.

The report focused on 74 studies conducted on 12 antidepressants. Thirty-eight of the studies had favorable results, all but one of which were published. But there were 36 studies that had negative or questionable results, and only three of those studies were published. An additional 11 studies with negative or questionable results were published, but were written as if there were positive results.

“Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome,” wrote the authors.

For example, GlaxoSmithKline’s (GSK) antidepressant Paxil had seven negative studies, five of which were never published. In addition, GSK’s Wellbutrin had three studies, two of which were negative and never published.

Pfizer also had five studies conducted on its drug Zoloft, but three studies that showed the ineffectiveness of the drug were not published. A fourth questionable study was written and published to make it look like the drug worked.

The study is significant because allowing companies to publish only positive studies of antidepressants may allow them to make inflated claims about the efficacy of the drugs, thus making it virtually impossible for doctors and patients to know how effective or ineffective the drugs are. It can also hide data on side effects of drugs.

Dr. Thomas P. Laughren, director of the division of psychiatry products at the FDA, said the agency has known favorable studies are more likely to be published for a long time.

“It’s a problem we’ve been struggling with for years,” Laughren said.

Sources: Benedict Carey, “Antidepressant studies unpublished,” New York Times, January 17, 2008; Gene Emery, “Unfavorable drug studies don’t get into print: report,” Reuters.com, January 17, 2008; “Pharma companies hid antidepressant data,” Furious Seasons, January 17, 2008.

On January 7, 2008, United States researchers said severe warnings of suicidiality in young persons taking antidepressants have curbed these drugs’ rapid increase in growth, however access to the drugs for youths seeking treatment has not been eliminated. Antidepressant use had been growing at a rate of 36 percent per year before warnings were first issued in 2003, but the growth rate has flattened since that time.

Some mental health professionals feared the warnings, which apply to children ages 6 to 17, would limit youth access to the medications. And some doctors have interpreted a spike in suicide rates in 2004 as being tied to a decline in the use of antidepressants among children.

Antidepressants are used to treat depression, the leading cause of suicide. But regulators issued warnings on use of the drugs after trials showed they could actually increase the risk of suicidal thoughts and behaviors in youth.

The Food and Drug Administration (FDA) issued a “black box” warning, the agency’s strongest, to highlight the risk associated with the drugs. This caused some to fear the medications wouldn’t be as available for the youth who use them, but the most recent study found this was not the case.

“What we found is the FDA warnings had a relatively moderate and targeted effect in slowing the growth of antidepressant use by children,” said Dr. Mark Offson of Columbia Medical Center. The FDA plans to continue to monitor youth suicide rates.

Source: Julie Steenhuysen, “Effect of antidepressant warnings moderate-US study,” Reuters, January 7, 2008.

The FDA issued a Public Health Advisory today about Paxil (paroxetine), the prescription anti-depressant. The agency has determined that exposure to Paxil in the first trimester of pregnancy may increase the risk of congenital malformations in infants, particularly cardiac malformations.

Preliminary analysis of two unpublished studies bore this conclusion out. In a study using national registry data from Sweden, women who received Paxil in early pregnancy has an approximately two-fold increased risk for birthing an infant with a cardiac defect compared to the regular population. In a separate study of U.S. insurance claims data, infants of women on Paxil had a 1.5 times greater chance for cardiac malformations and a 1.8 times greater chance for congenital malfunctions in general. Paxil is manufactured by drugmaking giant GlaxoSmithKline plc.

The cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. Septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own.

Source: FDA Release, December 8, 2005.

A South Carolina couple is filing a lawsuit against the maker of Paxil claiming that the drug caused their daughter’s birth defect. Paxil’s manufacturer, GlaxoSmithKline, has faced several thousand Paxil lawsuits in the United States since the drug’s introduction in 1992.

In 2000, Taylor Dismuke was born with a heart malformation that required open heart surgery during her first week of life. The birth defect will affect her for a lifetime, as doctors say she will require more surgeries as she grows and powerful prescription drug therapy that will prevent her from ever having children.

Shannon and Kimberly Dismuke did not realize their daughter Taylor’s heart defect could be the result of Kimberly taking Paxil while pregnant. The Dismukes claim they were never told that the anti-depressant Paxil can cause birth defects in pregnant women. During her pregnancy, Kimberly discontinued a heart medication but continued taking Paxil.

“When we found out she was pregnant,” Shannon Dismuke said, “she was on several medications”¦ one thing we did ask was do we need to stay on [Paxil] and we were told yes.”

In September 2005, GlaxoSmithKline released the results of a survey that found an increased risk for pregnant women on Paxil to have children born with heart malformations. The Dismuke’s personal injury attorney says that since neither parent has a family history of birth defects, he believes Taylor’s heart malformation was directly related to Paxil. The case is expected to go to trial sometime in 2007 in Greenville, SC.

Though most Paxil product liability lawsuits assert that people who took the drug were not sufficiently warned in advance of its side effects, GlaxoSmithKline has not issued a Paxil recall.

Source: Angela May, “First South Carolina Paxil Lawsuit,” ABC 4 News, Charleston, SC, December 28, 2006, accessed January 4, 2007.

The U.S. Food and Drug Administration issued a warning September 28, 2005, to pregnant women taking Paxil that they may be twice as likely as other women to bear children with birth defects. A study sponsored by Paxil’s manufacturer, GlaxoSmithKline, suggests that the children of women taking Paxil, especially during the first trimester of their pregnancy, were twice as likely to have birth defects. The prevalence of birth defects in this group was 4 percent, or 43.6% per 1000 births.

The most common birth defect suffered by children born to women taking Paxil were ventricular septal defects, where one or more holes are present in the muscular wall separating the right and left ventricles of the heart. The overall rate of heart birth defects in the general population is about 1 percent.

GlaxoSmithKline has said it will send a letter to physicians alerting them to their findings. Paxil already has a pregnancy precaution, belonging to the Category C of prescription drug warnings, meaning that comprehensive studies evaluating the drug’s effect on unborn fetuses have not been done. Citing another survey of births, GSK says it does not note a comparable increase among users of other anti-depressants, but will not admit a causal link between their drug and birth defects.

Source: “Study hints at Paxil tie to birth defects,” Associated Press, September 27, 2005; Amanda Gardner, “New Warning Issued on Paxil,” HealthDay News, September 28, 2005.

A study by researchers at the University of British Columbia in Vancouver has uncovered a higher risk for low birth weight and respiratory distress in infants born to mothers on SSRI antidepressants.

SSRIs, or selective serotonin reuptake inhibitors, work by preventing the reuptake, or re-absorption, or serotonin in the brain. Serotonin is considered a key ingredient in the chemical mix that affects mood levels. Dr. Tim F. Oberlander and colleagues examined population health data for nearly 120,000 live births between 1998 and 2001, of which 14 percent of children were born to mothers diagnosed with depression.

Researchers compared neonatal outcomes of 1451 children born to mothers diagnosed with depression and treated with SSRI medications to 14,234 children of mothers also diagnosed with depression but not treated with SSRIs. Children whose mothers took SSRIs suffered a 13.9 percent rate of respiratory distress, which is significantly greater than the 7.8 percent experienced by the children of mothers who did not take the drugs. In addition, infants whose mothers were on SSRIs experienced longer hospital stays, lower birth weights, and earlier gestational age. A larger proportion of babies born to mothers on SSRIs were born before 37 weeks.

“Our study may add another cautionary note to the use of SSRI medications during pregnancy,” Dr. Oberlander said, explaining that the study’s findings are contrary to an expectation that treating mothers for their depression would help lessen the adverse neonatal consequences associated with maternal depression, such as poorer cognitive performance, behavioral problems that can extend into adolescence, lower IQ scores, and disorders such as attention deficit/hyperactivity disorder (ADHD).

Sources: David Douglas, “Antidepressants during pregnancy may affect baby,” Reuters Health, August 25, 2006; Canadian Pediatric Society, “Maternal depression and child development,” Pediatrics & Child Health 9 (October 2004).

No parent wants to hear the news that their child suffers severe birth defects. Lisa Collins Steele’s nine-month-old son, Chase, was born with half a heart. Since his birth, Chase has had to undergo one open heart surgery, a dozen emergency trips to the hospital for care, and is currently on life support. Ms. Steele now faces hundreds of thousands of dollars in medical bills that may never end. She believes her son’s suffering could have been prevented if she had been warned not to continue taking the anti-depressant Paxil while she was pregnant.

Ms. Steele has filed a lawsuit against GlaxoSmithKline and her physician, alleging product liability and negligence in her case.

Ms. Steele stopped taking Paxil a few months before a warning was issued in December 2005 by GlaxoSmithKline and the U.S. Food and Drug Administration that pregnant women taking Paxil faced a higher risk of their children being born with birth defects, especially cardiovascular defects. According to Ms. Steele’s personal injury attorney, if Ms. Steele had been aware of this risk, she would not have taken Paxil.

According to the attorney representing Ms. Steele, there may be as many as 50 additional personal injury cases being reviewed for potential litigation against GlaxoSmithKline involving similar defects in children born to women who took Paxil during their pregnancy.

Source: Chau Nguyen, “Litigation against Paxil begins,” KHOU.com, August 2, 2006.

Anthony and Matilda Vasquez of Bedford, TX filed a personal injury lawsuit against GlaxoSmithKline, the maker of the anti-depressant medication Paxil. The Vasquez family alleges that the company failed to warn patients about birth defect risks associated with Paxil for pregnant women. Mrs. Vasquez took Paxil during her pregnancy, and her son Adrian, age two, was born with birth defects so severe that he had three separate open heart surgeries and now has a pacemaker.

Adrian Vasquez underwent three open-heart surgeries during his first year of life, including his first surgery at eight days old. He also underwent four cardiac catheterizations and thirty echocardiograms within his first few months. Adrian is behind on verbal and motor skills for children his age. Although his health has since improved, Adrian will need repeated heart surgeries and may require artificial replacement valves, and perhaps a heart transplant, as he grows older.

In 2003, a retrospective analysis of women who had taken anti-depressants in the first trimester of their pregnancies as far back as 1995 showed a more than two-fold increase in congenital malformations in children born to women taking Paxil compared to other anti-depressants. In September 2005, GlaxoSmithKline sent a “Dear Doctor” letter to healthcare providers in the U.S. advising them that the results of its analysis of children born to women taking Paxil during their pregnancy found a higher rate of congenital malformations, the most common being cardiovascular defects. GlaxoSmithKline stated in the letter that ventricular septal defects were a particular risk for children whose mothers took Paxil while they were pregnant.

The U.S. Food and Drug Administration has since changed Paxil’s pregnancy warning category from Category C to a Category D. Category D pregnancy warnings are used to indicate to patients that there is “positive evidence of fetal risk” from a pharmaceutical medication. A Category C warning indicates that the drug has not been adequately tested in clinical trials to assess its risk to fetuses. The FDA recommends that drugs in the Category C pregnancy class should only be used if the risk to the fetus is carefully weighed against its benefits to the mother. In September 2005, GlaxoSmithKline company spokesperson Mary Ann Rhyne stated, “This is a medicine doctors should already be talking with patients about.”

Source: “Child with Severe Heart Birth Defects Sues Paxil Maker,” Baum Hedlund, July 28, 2006; Amanda Garnder, “New Warning Issued on Paxil,” September 28, 2005.

The U.S. FDA has issued a public heath advisory warning of the potential of a life-threatening problem known as serotonin syndrome, which could be caused by the combination of certain migraine drugs with some popular anti-depressants. Both types of drugs are designed to boost the levels of the chemical serotonin in the brain. Symptoms of serotonin syndrome include:

• Restlessness
• Hallucinations
• Loss of coordination
• Over-active reflexes
• Fast heartbeat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea
• Vomiting
• Diarrhea

The FDA received 27 reports of serotonin syndrome occurring in patients in the U.S., 13 of which involved patients who had to be hospitalized. Two of the cases were considered life-threatening. In response, the FDA is asking makers of the drugs in question to update drug labels to include a warning about the potential of developing serotonin syndrome.

The migraine headache medicines involved are known as triptans. Triptans are a newer class of abortive pain medications that work by binding to serotonin receptors in blood vessels, causing them to constrict and, thereby, controlling the inflammation that is a cause of migraine pain in some patients. Triptans linked to serotonin syndrome include the following medications:

• Amerge (generic name: naratriptan)
• Axert (generic name: almotriptan)
• Frova (generic name: frovatriptan)
• Imitrex (generic name: sumatriptan)
• Maxalt, Maxalt-MLT (generic name: rizatriptan)
• Relpax (generic name: eletriptan)
• Zomig, Zomig ZMT (generic name: zolmitriptan)

The anti-depressants that have been linked to serotonin syndrome in combination with these migraine medications are of two classes: selective serotonin reuptake inhibitors, or SSRIs, and serotonin-norepinephrine reuptake inhibitors, or SNRIs. SSRIs work by slowing down the re-absorption of serotonin into the system. SNRIs perform the same function, but also work to slow down the re-absorption of norepinephrine as well.

Anti-depressants that have been linked to serotonin syndrome include:

• Celexa (generic name: citalopram)
• Cymbalta (generic name: duloxetine)
• Effexor (generic name: venlafaxine)
• Fluvoxamine
• Lexapro (generic name: escitalopram)
• Paxil (generic name: paroxetine)
• Prozac (generic name: fluoxetine)
• Symbyax (generic name: olanzapine/fluoxetine)
• Zoloft (generic name: sertraline)

The FDA has advised physicians prescribing a triptan, SSRI or SNRI to discuss the possibility of developing serotonin syndrome with patients and follow their patients closely if a triptan and an SSRI or SNRI are used together. Patients who experience any of the symptoms of serotonin syndrome as described above should immediately seek medical attention.

Sources: FDA Release, July 20, 2006; Jennifer Corbett Dooren, “FDA Warns of Possibly Lethal Drug Combination,” Wall Street Journal, July 20, 2006; Miranda Hitti, “FDA: Triptan Migraine Drugs May be Dangerous if Taken with SSRI or SNRI Antidepressants,” WebMD Medical News, July 19, 2006, accessed July 20, 2006.

A review in the May 18th issue of the Journal of the American Medical Association reports that infants exposed to SSRI (selective serotonin reuptake inhibitor) antidepressants shortly before birth were three times as likely to exhibit behaviors like jitteriness, respiratory distress, and fussiness as nonexposed infants and those exposed only during early pregnancy. Most reports of antidepressant-related complications occurred in children exposed to Prozac and Paxil. Symptoms associated with Zoloft, Celexa, and Effexor exposure were less common, but still significant. The study reviewed cases of newborns born to women taking antidepressants over the past decade.

Infants exposed to the drugs also have twice the risk of respiratory complications. In some of the cases studies, complications were serious enough to require ventilation. In some cases infants suffered seizures. SSRIs like Prozac and Paxil are the most widely prescribed antidepressants used today.

Source: Salynn Boyles, “Antidepressant Drug Exposure Affects Infants,” WebMD Medical News, May 17, 2005.

Due to US Food and Drug Administration concerns about manufacturing standards violations at GlaxoSmithKline, Inc., facilities that may have resulted in the production of poor quality drugs, the US Department of Justice today initiated seizures of Paxil CR tablets and Avandamet tablets at GSK facilities in Cidra, Puerto Rico, and Knoxville, TN. GSK had voluntarily recalled some of the affected lots of Paxil CR and Avandamet but had failed to recall all lots, resulting in the DOJ actions today.

Violations noted during the last FDA inspection was the finding that Paxil CR tablets could split apart, resulting in patients receiving a portion that lacks any active ingredient. The splitting of the tablet could also result in a patient receiving a portion of the tablet that contains the active ingredient but does not have the intended controlled-release effect. The FDA also found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active drug ingredient.

Manufacturing procedures at GlaxoSmithKline were described by the US FDA in its press release as failing to meet its standards that “ensure product safety, strength, quality and purity.” The FDA urges patients who use these drugs to continue taking their tablets but to talk with their health care provider about using possible alternative products until the manufacturing problems have been deemed to be corrected. Patients are advised that they should not stop taking prescribed medications without first consulting with their physician, as many drugs may have severe withdrawal side-effects.

Prescription drugs such as Zoloft and Effexor are increasingly being prescribed to children and teenagers to alleviate symptoms of depression. In 2002, doctors wrote nearly 11 million prescriptions to children - about 7 percent of all antidepressant prescriptions nationwide. A panel asked to study this rising trend in the US reported to the US Food and Drug Administration that patients who take antidepressants are twice as likely as those given placebos to become suicidal. The risk worried the panel because the benefits of these antidepressants are unclear. Most of the drugs, including Fluoxetine, Paxil, and Prozac, failed to relieve the symptoms of depression in teenagers and children in clinical studies.

As a result of their research, the panel voted 15-8 that the FDA mandate that these drugs contain “black box” warnings on the sheet of information that physicians review when prescribing drugs. A “black box” is a boldface warning surrounded by a black border that is placed at the top of a drug’s warning label. The panel also voted unanimously to recommend that the agency require drug manufacturers to attach a patient guide to the drugs’ packaging that clearly describes the drugs’ risks for suicide in plain language. Many FDA-approved drugs have black box warnings, but less than 30 are required to have such documentation attached to information given directly to patients. While the FDA is not required to follow the advice of its advisory panel, it usually does so.

The committee heard from dozens of bereaved parents who described doctors who prescribed antidepressants to children for conditions the drugs were not intended to treat, and failed to warn them of the risks.

Source: Gardiner Harris, “Panel urges stern warning on drugs’ risk,” New York Times, September 15, 2004.

The U.S. Food and Drug Administration has issued a warning stating that anyone taking any of the 10 most popularly prescribed antidepressants, especially children, may be prone to the worsening of depression or suicidal thoughts. These side effects have a greater chance of developing at the beginning of treatment or with an increase or decrease in dosage. The FDA has asked the manufacturers of these drugs to place labels on the bottles warning of possible suicide, worsening depression, anxiety, and panic attacks in adults and children.

The Antidepressants the FDA cautions patients about are as follows:

• Prozac
• Zoloft
• Paxil
• Luvox
• Celexa
• Lexapro
• Wellbutrin
• Effexor
• Serzone
• Remeron

These warnings are intended for adults and children taking these drugs. Family members should pay attention to any behaviors of those taking antidepressants that are unusual for the patient.

Aside from looking for signs of worsening depression, the following symptoms may also be signs of a worsening depressive problem:

• Anxiety
• Agitation
• Panic Attacks
• Insomnia
• Irritability
• Hostility
• Impulsivity
• Severe restlessness
• Mania in both adults and children being treated for major depression

Antidepressants can also cause problems for people with undiagnosed bipolar disorder. There is a possibility that antidepressants may cause manic episodes in such people. Doctors, patients, and family members should watch for symptoms of mania, such as extreme happiness or irritability, inflated self-esteem, decrease in sleep, and talking or being more active than usual. While adults should be watched for the development of any of these symptoms, children are especially vulnerable and should careful attention should be paid to them.

Source: Jeanie Lerche Davis, “FDA Issues Warning on Antidepressants,” WebMD.com, March 22, 2004.

A study conducted on patients taking selective serotonin reuptake inhibitors (SSRIs), such as Prozac, Zoloft, and Paxil, found that study patients were at a moderate risk for stomach and intestinal bleeding. These patients were four times more likely to be hospitalized with stomach or intestinal bleeding than those not taking these antidepressants.

These risks are increased five times when SSRIs are paired with aspirin or other anti-inflammatory pain relievers. The risk can be twelve times as high when taken with anti-inflammatory drugs such as ibuprofen.

SSRIs are thought to increase bleeding by decreasing the ability of platelets to clot the blood. Research has shown that all SSRIs increase the risk of bleeding as well as other drugs affecting serotonin levels, including Tofranil and Elavil. People who are already at a high risk for bleeding - the elderly and those with a prior history of bleeding- should be especially cautious when taking SSRIs.

Source: Salynn Boyles, “Antidepressants Tied to Stomach Bleeding,” http://www.webmd.com, January 17, 2003.

In October 2006, pharmaceutical company GlaxoSmithKline agreed to pay $63.8 million to settle a lawsuit in which plaintiffs claimed the company promoted its antidepressant drug Paxil for children and adolescents but failed to provide negative information about the product’s safety and effectiveness.

Plaintiffs included US residents who bought Paxil and Paxil CR for their children and are eligible to receive full refunds if they have records of their purchases. Consumers without documentation may receive a return of $15.

The company denied the lawsuit’s claims, including that consumers paid too much for the drug, but said it settled because it wanted to resolve the matter to avoid further court costs.

Payments to consumers in this case will depend upon the number of claims. If claims exceed the settlement amount, consumers will receive a portion of their refund amount.

Source: “Glaxo settles Paxil suit for $63.8 million,” Philadelphia Inquirer, November 2, 2006.

The parents of a child born with severe Persistent Pulmonary Hypertension (PPHN) have filed a personal injury lawsuit against GlaxoSmithKline (GSK), the manufacturer of the antidepressant Paxil. The family alleges that taking Paxil while she was pregnant caused Lisa Boden’s son Eric Jackson to be born with the life-threatening birth defect that kills as many as 20 percent of infants diagnosed with PPHN.

PPHM is a disorder in which the amount of blood flow to a newborn’s lungs and oxygen in the bloodstream is limited because the arteries remain constricted after delivery. While treatment is available, 10 to 20 percent of infants with PPHN will die from the disorder.

Christopher Jackson and Lisa Boden of Denver, CO, parents of Eric, hired a product liability lawyer and filed a suit against GSK, which is based in Philadelphia, in Pennsylvania State Court. Boden took Paxil throughout her entire pregnancy and is alleging the company didn’t adequately warn consumers about risks associated with Paxil for pregnant women and their unborn children.

Eric Jackson has undergone several procedures to save his life since his birth, including being placed on a ventilator immediately after birth and remaining on an oscillating ventilator for a month. He also had two cardiac catherizations and a procedure to combat acid reflux that was caused by being on a ventilator for an extended amount of time. He is currently remaining on oxygen and medications to help him breathe.

This is the first PPHN Paxil birth defect lawsuit filed against GSK.

Source: “First PPHN Paxil birth defect personal injury lawsuit filed - child born with life-threatening Persistent Pulmonary Hypertension (PPHN) sues Paxil-maker,” NewsReleaseWire.com, October 16, 2006.

*GlaxoSmithKline PLC, maker of the antidepressant medication Paxil, informed healthcare professionals on Friday, May 12, 2006 via a “Dear Doctor” letter that Paxil appears to raise the risk of suicide in young adults. New analysis of its own data from clinical trials showed that 11 patients out of 3,455 taking Paxil for depression in clinical trials reported an attempted suicide. Glaxo found no increased risk of suicidal behavior in adults over the age of 30, but the frequency of suicidal behavior was higher in all patients treated with Paxil (.318%) when compared with patients taking a placebo (.05%).

Paxil is part of a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil was first approved in the U.S. in 1992 for the treatment of depression and is known generically as paroxetine.

The entire class of antidepressant medications has faced increased scrutiny from the U.S. Food and Drug Administration because of links to suicides. All antidepressants carry warnings for increased medical monitoring of patients during the early stages of antidepressant medication therapy due to the risk that patients may actually grow more depressed. Such warnings are included in “black-box” warnings, special indications on pharmaceutical product labeling that are bordered with a black box to indicate the more serious nature of the risk involved in using such a product. Many black-box warnings are placed on drug packaging only after increased pressure from consumer groups and federal agencies.

Sources: Etain Lavelle, “Glaxo Warns of Paxil Suicide Risk in Young Adults,” Bloomberg.com, May 12, 2006, accessed May 15, 2006; GlaxoSmithKline PLC release, May 12, 2006; Lisa Richwine, “US cites suicidal acts in adults on Glaxo’s Paxil,” Reuters UK, May 12, 2006, accessed May 15, 2006.

Researchers at Duke University in Durham, NC, have found that antidepressants may be dangerous for patients with coronary heart disease. An observational study performed by Dr. Lana L. Watkins and her colleagues at Duke found that 21.4% of patients being monitored for depressive symptoms and antidepressant use who had also been hospitalized for coronary angiography died, compared with 12.5% of coronary angiography patients who were not on antidepressants.

Coronary angiography is a procedure used to diagnose heart disease. Researchers monitored 921 patients aged 29 to 90 years for three years. While it’s possible that patients taking antidepressants had other risk factors that could account for the increased risk, Dr. Watkins advises physicians to closely monitor their patients with coronary disease who are taking antidepressants. Duke University researchers had previously reported that the presence of depression is an important risk factor for heart patients.

Source: Karla Gale, “Antidepressants may pose risk to heart patients,” Reuters, March 6, 2006.

Researchers at the University of Oslo in Norway have found an increased risk of suicide among patients prescribed the antidepressant Paxil (paroxetine), sold as Seroxat in Europe. Dr. Ivar Aursnes and his colleagues studied 916 adults on paroxetine and compared them with 550 patients taking placebos. Of the Paxil patients, seven committed suicide, compared to one suicide in the control group.

In December 2004, the UK Department of Health issued new guidance on Seroxat/Paxil indicating that the drug should not be given as an initial treatment to patients exhibiting symptoms of mild depression due to the increased risk of suicide. In April 2005, European health regulators warned all countries in the European Union that Seroxat/Paxil and other antidepressants should not be used to treat children and adolescents. The Oslo researchers came to similar conclusions and strongly advised that patients and doctors should be warned of the propensity to suicidal thoughts while on Seroxat/Paxil.

GlaxoSmithKline, the drug’s manufacturer, immediately issued a statement that the findings of the Oslo researchers does not reflect the picture they gained in their clinical trial program which involved 24,000 patients.

Sources: Genevieve Roberts, “Antidepressant Seroxat linked to suicide attempts among adults,” Independent Online, August 22, 2005; “Glaxo’s Paxil Antidepressant Linked to Suicide,” Bloomberg.com, August 21, 2005.