Healing the Mind, Punishing the Body

Doctors beginning to warn mental patients about psychiatric drug side effects

cont.

Lilly contends that those with psychoses tend to suffer from diabetes and other health problems anyway and that the link to its drug is unproven. By settling, the issue may never be resolved, which leaves Liversidge "extremely disappointed."

Her goal in suing was not so much to make the company pay for her son's death, she explained, as to "help the industry clean up its act a little more, not let it be so secretive when it makes mistakes."

The FDA, meanwhile, has become more aggressive in looking for previously unsuspected problems with drugs already on the market, and more open with doctors and the public about potential problems, even if they haven't been proved.

"Society is moving in a direction where people want more information earlier and want to be able to make determinations about products prior to organizations like the FDA announcing whether or not the label should change," said Dr. Paul Seligman, who oversees the regulator's surveillance of drugs once they go on the market.

In addition to its planned "Drug Watch" Web site, the FDA has begun using sophisticated software to analyze the more than 3 million "adverse events" reported to the agency about patients taking approved drugs of all kinds, to uncover previously unidentified side effects.

More cautious approach

The most recent use of the agency's "data mining" technique uncovered another potential concern regarding one or more atypical antipsychotic medications. Researchers from the FDA and Duke University found more reports of benign pituitary tumors among patients taking risperidone than in those taking similar drugs.

Though uncommon and not malignant, such tumors can harm vision and cause other health problems if untreated. Seligman said the agency plans a closer look to see if the apparent tumor link holds up and what, if any, changes should be made to drug labels to alert doctors and patients.

Doug Arbesfeld, a spokesman for Janssen Pharmaceutica, which sells the drug under the name Risperdal, stressed that the findings were preliminary but agreed that more study is warranted.

The series of FDA warnings and research findings have forced psychiatrists to take a much more cautious approach to prescribing what all agree are still extremely beneficial medications for otherwise intractable mental illnesses. Often, they must try to determine which drug may help ease a patient's psychosis while at the same time posing the least physical health risk.

Newer drugs, such as aripiprazole, sold since November 2002 as Abilify, seem relatively free of side effects, but haven't been on the market long enough to assure some clinicians.

Even before problems with atypical antipsychotics began to be reported publicly, Duckworth says, he started noticing that patients at his community health center at Harvard were dying of heart disease in their 40s and 50s.

Some of that may have been the result of bad habits like chain-smoking. But taking the drugs they need for mental illness may exacerbate physical health risks.

Now, in addition to weighing his patients and checking their blood-sugar levels, Duckworth says he counsels them to cut back on smoking, watch what they eat and exercise. There aren't many alternatives, he notes, because these drugs are about the only hope for many battling severe mental illnesses.

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"This is psychiatric chemotherapy," he explains to his patients. "I say this is going to be really hard on your body, and it might be good for your brain."

While most doctors recognized that many patients gained weight taking antipsychotics, researchers found evidence suggesting that patients taking olanzapine and similar drugs were more likely to develop diabetes and hyperglycemia, a related failure of the body to process sugar, which can lead to coma and death if left untreated.

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Source: Baltimore Sun

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