FDA ISSUES WARNING LETTER TO CLINICAL INVESTIGATOR AFTER PATIENT VOMITS BLOOD

A patient who suffered gastrointestinal (GI) bleeding during a clinical trial prompted the FDA to send a warning letter to the clinical investigator, Evangeline Gonzalez of Gonzalez Internal Medicine.

The patient went to another doctor with complaints of vomiting blood and blood in her stool, and was diagnosed with a GI bleed of such severity that she was hospitalized from Sept. 27, 2001, to Oct. 1, 2001, and needed a transfusion of three units of blood, the warning letter said.

According to the warning letter, the study was a randomized clinical trial in which patients received either aspirin or a placebo. The letter stated that the study coordinator screened and enrolled "subject 233" on July 11, 2001, despite the fact that this volunteer met several "exclusion criteria" listed in the trial protocol, including a history of peptic ulcer disease with an episode of GI bleeding, the fact that she was taking Celebrex for a degenerative arthritic condition, the fact that she had a known allergy to Anacin, which contains aspirin, and the fact that she had a body mass index of 51.6, well above the maximum of 32.0 specified in the protocol.