FDA Probing Reactions To New Kidney Transplant Drug
Aug. 28, 1986
ATLANTA (AP) _ A possible link between a new anti-organ-rejection drug given to kidney transplant patients and a type of meningitis is being investigated, federal health officials said Thursday.
The Centers for Disease Control reported that last month, soon after taking the drug, four patients at two Iowa hospitals developed signs of meningitis, or inflammation of the membranes lining the brain and nervous system, including fever, headache, nausea and tremors.
Symptoms in all four patients disappeared within five days, with no signs of damage to the nervous system, the CDC reported.
The Ortho Pharmaceutical Corp., the maker of OKT3, said Thursday its scientists were aware from early trials that such symptoms might accompany initial injections with the drug.
In fact, company officials say, a notice about the possible side effects is included in the literature doctors receive with supplies of the drug, which was licensed in late June and is in wide use.
''It's a necessary evil of this preparation,'' said Dr. Gideon Goldstein, an Ortho vice president. ''It's a necessary evil which people put up with because the results are so outstanding. The drug is first-class.''
Spinal taps performed on all four Iowa patients, at the University of Iowa Hospital and the Veterans Administration Hospital in Iowa City, ''suggested aseptic (unknown-cause) meningitis,'' the CDC said in its weekly report.
Meningitis, when caused by various viruses, can be severe and contagious. But spinal fluid and blood tests on the Iowa patients, as well as on six patients with similar signs in Ortho's own trials, revealed no signs of any viral meningitis.
To a physician, symptoms such as those seen in the Iowa cases ''mean infectious meningitis,'' Goldstein said. ''The main importance is to understand that this may occur, and not to be too concerned.''
The New Jersey company wants to make sure doctors are aware of the drug's side effects and do not perform unneccessary spinal taps, he added.
The U.S. Food and Drug Administration and the manufacturer have launched a new evaluation of the product, aimed at determining the incidence of its side effects.
Doctors should, for now, observe the reaction and report cases to the drug company and health officials, said Faye Peterson, a spokeswoman for the FDA.
Other drugs are available to help patients fight off the body's inclination to reject a transplanted kidney, but OKT3, an antibody preparation, is ''the only one of its kind on the market,'' Ms. Peterson said. ''It has been useful in treating some patients that did not respond to those previously available products,'' she added.
Ortho's own pre-licensing tests showed that high fever may occur temporarily in 73 percent of patients taking the drug, and that headache is very frequent, Goldstein said. Such reactions do not occur after the first or second injections, he added.
Goldstein characterized the drug's side effects are ''benign and self- limited. People are willing to put up with that for a couple of days to save a kidney.''