FDA Approves Geodon
May 15, 2001
Schizophrenics have a new choice for medication, thanks to the Food and Drug Administration's approval of Geodon. Schizophrenia is a complicated disorder that causes delusions, hallucinations and strange thinking patterns, all of which result in the schizophrenic's withdrawal from society.
According to critics, Geodon will be another drug in a long line of medications that prolong the heart's QT interval. An interruption in the QT interval can sometimes lead to fatal heart-rhythm disturbances. Critics also maintain that because Geodon did not outperform any of the drugs already on the market for schizophrenia, it should not have been approved by the FDA. The FDA disagreed, however, and Geodon will now be available for doctors to prescribe to schizophrenic patients.
Spokespeople from Pfizer, Inc. argue that Geodon has several benefits that other drugs do not have. Most importantly, the company claims that Geodon does not cause unwanted weight gain. Studies show that many of the already existing schizophrenia drugs cause weight gain, a side effect that deters many patients from taking their medication. Also, during Geodon's trial period, patients were less likely to have a relapse of symptoms and experienced less twitching than those patients taking other schizophrenia drugs.
Those opposed to Geodon's release believe that the only reason Pfizer is anxious for approval is because the company has invested many millions of dollars in research, development, and testing in the drug. Projections for Geodon show that it will secure about one-tenth of the schizophrenia drug market, potentially earning Pfizer over $2 billion per year. Public Citizen, a consumer advocacy group, claims that the FDA's approval of Geodon is another sign that the Federal agency is moving too quickly to approve new drugs, even when similar or better alternative drugs already exist.
Pfizer, Inc. disagrees. According to the company's studies, after one year almost 60% of Geodon users had not experienced a schizophrenic relapse. Evidence also suggests that a percentage of those patients who suffer from drug-induced heart rhythm disorders may be explained genetically.
Approval of Geodon was initially rejected by the FDA due to the drug's tendency to prolong the QT interval. An FDA memo stated, "this [Geodon] represents a risk of potentially fatal ventricular arrhythmia (heart rhythm disturbances)," and that this problem was "not outweighed by a demonstrated and sufficient advantage of ziprasidone (Geodon) over already marketed antipsychotic drug products." However, after a second round of testing, Geodon did receive final approval from the FDA despite the agency's earlier concerns. After reviewing a study of 4,500 patients, the FDA has determined that Geodon is safe and effective, but the agency would not say whether or not the drug was safer or more effective than schizophrenic medications already on the market.
-- Article Courtesy of InjuryBoard.com
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