[News in medical law. May 2003 to October 2003].
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Biomedical subjects
Publications and source records attributed to A Wienke.
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BACKGROUND: Localization of dural fistulas in the region of the anterior or lateral skull base may be difficult. For many years, a sodium fluorescein solution of 0.5 to 5% (2.5-50 mg) has been administered intrathecally by way of the lumbar space. However, fluorescein is not commercially available for this stated purpose in either Germany or the United States. METHODS: Retrospectively, 420 fluorescein applications by the authors were retrospectively analyzed. Under the Freedom of Information Act, the United States Federal Drug Administration and the manufactures of fluorescein were queried for adverse reaction reports. RESULTS: Four hundred twenty fluorescein applications in 305 patients could be evaluated. Mean age of recipients was 46.9 years, ranging from 1 to 82 years. At a concentration of 5% fluorescein, 26 patients on the day of surgery and 69, 37, 34, and 14 patients on days 2 through 4 suffered from minor side effects that may or may not have been related to this drug. Two of these patients had grand mal seizures, which were attributable to simultaneous intrathecal application of contrast medium. All other side effects were thought to be the result of a postspinal headache and related lumbar puncture. At a concentration of 0.5%, the intraoperative intrathecal administration of 0.5 to 2 mL of fluorescein followed by 4 to 5 days of lumbar drainage resulted in some degree of spinal headache without other complications. In both groups, no patient had sequelae longer than 4 weeks. An additional seven complications were reported to the Federal Drug Administration and the fluorescein manufacturers at doses of 100 to 700 mg. CONCLUSIONS: Complications from intrathecal application of fluorescein appears to be dose dependent. At concentrations of 5%, or preferably lower, side effects are transient. A grand mal seizure can be minimized when following the general cautions of lumbar puncture and dose. The patient should be supervised for 24 hours. A written informed consent from patients for use of fluorescein is recommended.
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BACKGROUND: The detection of cerebrospinal fluid fistulas in the region of the anterior or lateral skull base can be difficult. The fluorescein test with lumbar administration of 5% sodium fluorescein solution can be used to detect cerebrospinal fluid leakage, identify weak points in the dura, achieve precise localisation of cerebrospinal fluid fistulas and to check intraoperatively that watertight dural closure has been achieved. However, use of the test is problematic as the fluorescein solution used is not licensed for this indication in Germany and severe neurological complications are described in the literature. In order to clarify the legal situation regarding use of the test, we therefore analysed the complications occurring in a sizeable patient sample. METHOD: The records of all patients in whom a fluorescein test had been performed between 1979 and June 2000 were analysed retrospectively for the occurrence of complications. RESULTS: The most frequent complication in the 368 fluorescein tests performed was headache, followed by nausea and vomiting, temperature elevation, dizziness and nuchal pain. These side-effects were no more frequent than described for lumbar puncture alone. Twenty-six patients experienced side-effects on the day of the operation, 65 on the first postoperative day, 36 on the second day, 34 on the third day and 13 patients after the third day. There were two cases of grand mal seizures following concomitant intrathecal contrast medium administration. None of the patients had side effects persisting longer than 4 weeks. CONCLUSIONS: Intrathecal administration of a 5 % fluorescein solution is a safe procedure provided that the maximum dosages are not exceeded and the solution is prepared and administered correctly and in accordance with the specified indications and contraindications. In view of its great diagnostic benefit and low risk when properly used, the dictates of therapeutic freedom allow use of this drug despite the fact that it is not licensed for this purpose in Germany. It is necessary to obtain written informed consent from the patient.
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