Xref: pa.dec.com sci.med:28368 sci.psychology:5734 alt.religion.scientology:295
Newsgroups: sci.med,sci.psychology,alt.religion.scientology
From: sdb%hotmomma@uunet.uu.net (Scott Ballantyne)
Subject: FDA Dismisses Scientology's Claims about Prozac
Message-ID: <1991Aug5.041337.4740@hotmomma.UUCP>
Sender: sdb%hotmomma@uunet.uu.net (Scott Ballantyne)
Organization: ScotSoft Research
Date: Mon, 5 Aug 1991 04:13:37 GMT

The following press release from the FDA should be of interest to those who have been following the Prozac/Scientology battles.


On July 26, 1991, FDA informed the Citizens Commission on Human Rights (CCHR), a group affiliated with the Church of Scientology, that the agency was denying its request to withdraw marketing approval for the antidepressant drug Prozac (fluoxetine hydrochloride). The agency decided that withdrawal proceedings were not warranted.

CCHR submitted its petition to FDA in October 1990, and supplemented it with further submissions in November 1990 and June 1991. The petition, along with other letters from the group, asked the FDA to withdraw Prozac from the market because of its purported links to suicide, violent behavior and movement disorders, as well as its alleged addictive nature.

FDA reached these conclusions after carefully reviewing each of these charges and the evidence provided by the group. In addition, FDA examined data supplied by the drug's manufacturer, Eli Lilly and Company of Indianapolis, including data from controlled clinical studies on the drug. Adverse reaction reports involving Prozac were also carefully scrutinized, as well as relevant published material on the drug.

FDA's review revealed no basis for concluding that Prozac caused these adverse clinical events. For example, CCHR based many of its claims that Prozac caused increased suicidality in depressed patients on increased frequency of adverse reaction reports of suicide and attempted suicide among depressed patients on Prozac. These data, however, provide no way of distinguishing the role of the patients' underlying medical condition and the role of the drug in causing these suicidal events. Depression itself is highly associated with suicide. An analysis of controlled clinical trials that allowed a direct comparison of the incidence of emergent suicidal thoughts and actions among individuals on Prozac, placebo or other antidepressants failed to find any greater risk among those on Prozac.

In general, FDA rejected CCHR's contention that the number of adverse reaction reports that have involved Prozac constituted evidence that the drug should be removed from the market. CCHR, in its petition and in other material, has stated that the agency received more adverse reaction reports about Prozac than any other drug in 1990. However, this fact must be evaluated in the proper context.

CCHR's argument ignores the wide variation in types of adverse reactions reported for Prozac. Many of these reports involve relatively minor problems. Moreover, the volume of adverse reactions associated with Prozac is not unexpected for a product that is widely used and that has been the focus of intense public interest.

FDA, in its denial letter to CHHR, did inform the group that the agency will continue to assess new information. To this end, the agency will convene a meeting of its Psychopharmacological Drugs Advisory Committee to consider the issue of suicidality associated with antidepressant drugs, including Prozac. All pertinent data on the possible relationship between these drugs and suicidality will be thoroughly reviewed at this meeting in order to resolve any concerns on this issue. CONTACT: Food and Drug Administration Press Office, 301-443-3285

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