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Opening Pandora's medicine cabinet

Hidden adverse reactions to antidepressants possible downside to misdiagnosis, misinformed.

BY JERRY DAVICH
Times Staff Writer

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Popular antidepressant drugs like Prozac, Paxil and Effexor offer millions of people a needed keel to stay afloat in life's choppy waters.

Taken daily, these pills typically keep them from capsizing into the depths of depression. But some users -- with more serious yet undiagnosed mental health conditions -- have seen their lives pirated by antidepressants and nearly pulled under by the drug's adverse reactions.

In some extreme cases, users have been pushed over the edge into violent psychotic episodes resulting in murder, suicide or both.

Thirty-seven-year-old Frank Kendall of Ogden Dunes is thankful he escaped.

On Nov. 1, Kendall "flipped out," as he put it, causing a 4-1/2-hour standoff with police and a SWAT team. A local business owner, Kendall began taking two medications for depression about eight weeks prior to the Nov. 1 standoff.

One of the antidepressants, Effexor, turned him into a completely different person as he tapered off the drug, he said.

Effexor was in the news last week when British drug regulators recommended against prescribing it and five other antidepressants to treat children under 18. Officials there also cautioned that users of Effexor should not stop taking it too abruptly. This is what possibly happened in Kendall's case.

Effexor's maker, Wyeth-Ayerst Laboratories, did not return phone calls for this story.

But in a "Dear doctor" letter dated Aug. 22, 2003, Dr. Victoria Kuslek, the firm's North American medical director, wrote: "In clinical studies in pediatric patients, efficacy was not established for major depressive disorder or generalized anxiety disorder, and there were increased reports among those patients... of hostility and suicide-related adverse events... and self-harm."

"The warning is for teens, but some adults must heed it also," said Ann Blake Tracy, director of the International Coalition for Drug Awareness, a watchdog group of the pharmaceutical industry.

It was Tracy who called comedian Phil Hartman's in-laws the day after he was killed in 1998 by his wife, who then killed herself. Tracy said Brynn Hartman was on the antidepressant Zoloft.

Tracy, who has testified in dozens of criminal cases involving these drugs, said few people have recall of what happened when they "flipped out."

After Kendall's incident blew over, he said it all seemed like a bad dream, a common pattern, Tracy said.

"If they do recall, it's as if they are watching themselves on TV and cannot stop it," said Tracy, who will be speaking at a government hearing in February, citing deadly examples why not all patients should be prescribed antidepressants.

Porter County Chief Deputy Prosecutor Brian Gensel said his office will review Kendall's medical records before deciding if he will face charges.

Four years ago, a Connecticut insurance man was acquitted of bank robbery charges after his lawyer convinced jurors that Xanax and Prozac impaired his client's judgment. But such court decisions are rare, experts say.

Story after story

In the summer of 2001, Jack Carson said his 16-year-old son suffered a "psychotic break from reality" after being on Zoloft for a month. His only son came home from church one Sunday night, chatted with his family, then went to his bedroom and unceremoniously ended his life by hanging himself from his closet rod.

"This was a young man with lots of friends, good grades, active in church and community activities and was a state champion in tae kwan do," said Carson, of Richmond, Va. "Nothing could have made me think he would do something like this."

For months Carson was at a loss to explain things, until he researched adverse reactions to antidepressants. Then it clicked, he said: "These drugs cannot be tolerated by a certain percentage of patients, and the risks of their usage are not clearly laid out in order for patients or in my case, their parents, to make an informed decision before using them."

A sad footnote to Carson's story is that on the one-year anniversary of his boy's death, the teen's grieving mother took her own life.

"This drug was responsible for the death of the only family I am ever likely to have," said Carson, who has since filed a lawsuit against Pfizer, Zoloft's maker. "I only wish someone would have alerted us about any possible adverse reactions. The doctor didn't."

Prior to his son's suicide, Carson said his boy's personality changed markedly, yet other times he seemed perfectly normal. His doctor said he was simply becoming acclimated to the medication and that, in time, his reaction would level off.

On Internet sites such as www.drugawareness.org, www.antidepressantsfacts.com, www.prozactruth.com and www.aspire.us, there are page after page of stories like Carson's, brimming with adverse reaction claims and the lawsuits against pharmaceutical firms that often follow.

Doctors -- the new gatekeepers

Antidepressants like Zoloft, Prozac and Paxil belong to a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs. In addition to depression, SSRIs are also marketed for obsessive-compulsive disorder, social anxiety disorder and panic disorder, eating disorders and sleep disturbances, among other things.

SSRIs are designed to block serotonin, a neurotransmitter in the brain, which then builds up to create overall higher serotonin levels in the brain, typically a good thing for people with depression and other disorders.

Antidepressant naysayers, however, claim the drugs do not belong in the hands of underinformed and overburdened primary care doctors, who write about 60 percent of all antidepressant prescriptions, according to the American Psychiatric Association.

With more general practitioners leading the way, there has been a 73 percent increase in antidepressant drug sales from 1998 to 2002, according to IMS Health, a pharmaceutical information and consulting firm.

"This class of drugs is amongst the most dangerous drugs ever unleashed onto an unsuspecting public," said Dawn Rider, a Utah mother whose son also committed suicide while on antidepressants.

"We are lulled into a false sense that the pain of depression... can be swept away with modern-day magic pills. The truth is that not everyone has the ability to metabolize these drugs," said Rider, who started a nonprofit organization for people to find safer alternatives than pharmaceutical pills.

The American Medical Association doesn't make distinctions of which doctors can or cannot prescribe antidepressants.

"All physicians can prescribe prescriptions, as they were trained to do," said spokesman Robert Mills.

And, he noted, guidelines for prescribing antidepressants are all product specific.

Much of the onus, experts say, is on the patient, who must be honest with doctors on how they're feeling -- good, bad or ugly -- during the critical early days and weeks of use.

"There are a certain number of patients who have more than just simple depression," said Dr. John Kern, medical director of Southlake Center for Mental Health. "Patients who have depression as part of bipolar disorder, also called manic-depressive illness, may look like any other depressed patient."

These patients, he said, may only be distinguished by a careful history, which a busy general practitioner may not have time to do. Or, if this is the beginning of their illness, it may be impossible to distinguish.

"If a depressed person knows they have a history of bipolar or manic-depressive illness, or if their problems include problems with agitation or hyperactivity, then they should avoid antidepressants and seek psychiatric care," he said.

Back in the early '90s, when primary care doctors began commonly prescribing antidepressants, psychiatrists like Kern thought it could help get people the treatment they need without patients having to stare down the stigma of mental health care.

The hidden by-product of this practice are cases that either were not diagnosed properly or monitored sufficiently after starting an antidepressant that possibly wasn't right.

"This," Kern said, "is the downside a decade later."

Jerry Davich can be reached at jdavich@nwitimes.com or (219) 933-3376.

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[EXTRAS]

The five-year rule

Because not enough research is always known about new antidepressants -- and other new drugs -- hitting the market, people should wait up to five years to take them unless it is clearly a rare breakthrough drug that offers immediate help or effectiveness, according to the Public Citizen Health Research Group, a national nonprofit agency. Otherwise, they are willing guinea pigs, the group stated.

FDA is listening
On Feb. 2, the U.S. Food and Drug Administration will host a hearing of the Psychopharmacologic Drugs Advisory committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee. In order to testify at that hearing on the adverse effects of antidepressants upon children and teens, people must contact Anuja Patel at (301) 827-6790 or e-mail her at patela@cder.fda.gov.

Study: Media doesn't help inform prescription drug users
The information people get on new prescription drugs from a major source -- daily newspapers -- is incomplete and may promote unrealistic expectations about the benefits of new drugs, according to a study released by the Canadian Centre for Policy Alternatives.
The report, "Drugs in the News," finds that newspaper articles more often emphasize the benefits of new drugs, while little attention is paid to possible harms. In fact, 68 percent of the news articles examined in more than 20 major newspapers made no mention whatsoever of possible adverse effects, and when identified, these harms were usually downplayed and mentioned towards the end of the article.
The study also found that contra-indications -- those conditions under which it is not safe to take the drugs -- were mentioned in only 4 percent of the articles, and only one in six articles mentioned alternative treatment options, like an existing or cheaper drug.

To report a reaction or call for help

To report adverse reactions of antidepressants to the U.S. Food & Drug Administration, contact the FDA's MedWatch reporting system by calling (800) FDA-1088 or visit online at www.fda.gov/medwatch or write to: MedWatch, HF-2, 5600 Fisher's Lane, Rockville, Md., 20852.
The Southlake Center for Mental Health in Merrillville has a 24-hour hot line for people in need. Call (219) 769-4005.

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