"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"...
INFORMATION FOR VACCINE RECIPIENTS AND PARENTS
Parents or guardians of infants and children to be vaccinated should be fully informed of the benefits and risks of vaccination with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM and the importance of completing the immunization series, unless contraindicated.
The physician should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM and other pertussis vaccine administrations. The parents or guardians of infants and children with family history of convulsions or other central nervous system disorders should be advised of the potential increased risk of seizures following DTP vaccinations.
Prior to each immunization, the parent or guardian should be provided with the Vaccine Information Materials (VIMs), as required by the National Childhood Vaccine Injury Act of 1986. 26 Parents or guardians should be instructed to report any severe or unusual reactions to their health-care provider.
The U. S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. 29, 30 The toll-free number for VAERS forms and information is 1-800-822-7967.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Certiva Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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