"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
OPV may not be as immunogenic in elderly patients or in patients suffering from immunosuppression (congenital, acquired, or iatrogenic). Furthermore, virus particle production can be potentiated in immunosuppressed patients, so OPV use is not recommended in these individuals. Patients with HIV infection may receive IPV or enhanced-potency IPV; however, OPV should be avoided.
Patients with evidence of viral infection (diarrhea, vomiting) should not be given OPV because other enteroviruses within the intestinal tract can inhibit immunity by preventing OPV replication. Similarly, OPV inoculation should be postponed in patients with fever or a severe respiratory infection, although minor illness does not preclude OPV administration.
Intramuscular injections, especially antibiotics, should be avoided for at least 30 days in patients who have received the poliovirus vaccine live oral (OPV) or for 60 days in patients who acquired the disease by contact with vaccine recipients. Intramuscular injections were associated with an increased risk of developing paralytic poliomyelitis in patients receiving IM injections 30 days prior to the onset of paralysis.
OPV is classified as pregnancy category C. Studies in humans have not been conducted. Problems in humans have not been reported, but routine administration of OPV during pregnancy is not recommended unless the benefits from vaccination outweigh the potential risks to the fetus. Poliovirus antibodies may be excreted into breast milk, and breast-feeding is not recommended for 2-3 hours before or after inoculation in neonates immunized at birth.
Use of OPV is not recommended in neonates less than 6 weeks of age.
Poliomyelitis has occurred after OPV administration both in vaccinees and in their close contacts. Poliovirus may be shed in the feces (and possibly from the pharynx) of vaccinees for 6-8 weeks after OPV administration. Contact individuals should be warned of the small risk of developing poliomyelitis and informed to wash hands carefully when exposed to feces or saliva of recently inoculated vaccinees.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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