Adr Headlines From 1999

In 1999, confidence in vaccinations received another blow following the withdrawal of rotavirus vaccine ("RotaShield") because of reports of intussusception, and there was misleading press coverage regarding the safety of the measles, mumps and rubella (MMR) vaccine. Investigations continued into the link between anorectic agents and valvular heart disease, the safety of sildenafil, and metabolic disorders associated with protease inhibitors. Fluoroquino-lones came into the spotlight when marketing of trovafloxacin and its IV formulation alatro-floxacin was suspended in Europe because of hepatotoxicity, and grepafloxacin was withdrawn worldwide later in the year following reports of fatal cardiovascular events.

"ROTASHIELD" WITHDRAWN IN THE UNITED STATES

In July 1999, the US Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) recommended temporarily suspending the use of rotavirus vaccine

("RotaShield") in infants, pending results of a case-control study to investigate a possible link between the vaccine and intussusception.76113 At this time, there had been 20 cases of intussusception in infants vaccinated with "RotaShield". Manufacturers of "RotaShield", Wyeth Lederle, suspended shipments of the vaccine at this time and sent out a letter to US physicians. The CDC subsequently began a review to determine whether intussusception is associated with rotavirus vaccine and other vaccines, in particular orally delivered vaccines.772:2

As of 9 September 1999, 99 cases of intussusception in children vaccinated with "RotaShield" had been reported to the US Vaccine Adverse Events Reporting System (VAERS).772:2 In October, Wyeth Lederle withdrew "RotaShield" from distribution in the United States, stating that the data continued to suggest a temporal association between administration of the vaccine and intus-susception.774:2

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