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Wyeth Lederle Announces Action On Rotavirus Vaccine |
SourceAmerican Home Products ForumsHealth, Safety, Nutrition and KidsInformation and news releases furnished by the members of PR Newswire, who are responsible for their fact and content. |
MADISON, N.J., July 15, 1999 -- Wyeth Lederle Vaccines, the
vaccine
division of American Home Products Corporation (NYSE: AHP), is announcing
a
number of steps to address questions raised by reports of intussusception
(a
cause of bowel obstruction in which one segment of bowel becomes enfolded
within another segment) in 20 infants immunized with RRV-TV (RotaShield(R)
Rotavirus Vaccine, Live, Oral, Tetravalent) during the period between
September 1, 1998 and July 7, 1999. It is estimated that approximately
one
million infants were immunized during this period. All of the patients
cited
in the reports were treated and have recovered.
Wyeth and The Centers for Disease Control and Prevention (CDC) believe that, while the current data are inconclusive in regard to a possible association between administration of RotaShield and intussusception, the reported cases raise questions and call for further study. Because more data are anticipated within several months and the rotavirus season is still approximately four months away in most parts of the United States, Wyeth and the CDC recommend postponing administration of RotaShield(R) vaccine to infants scheduled to receive the vaccine before November 1999, including those who have already begun the three-dose RotaShield series. According to the CDC, parents or caretakers of children who have already received rotavirus vaccine should promptly contact their health care provider if the infant develops symptoms consistent with intussusception (e.g., persistent vomiting, bloody or black stools, abdominal bloating, and/or severe colic pain). Parents who have questions about the vaccine should contact their physicians. In pre-licensure trials, there was no statistically significant increase of intussusception among infants who received RotaShield as compared to infants who were not immunized. Intussusception was identified in the label as a potential side effect that should be monitored and the 20 cases reported since vaccine licensure were discovered as the result of this surveillance. Reports generated by the Vaccine Adverse Events Reporting System (VAERS) -- a passive surveillance system operated by The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) -- identified 15 of these cases. Additional cases were identified from information provided by the Minnesota Department of Health. These data are summarized and reported in the July 16 edition of the Morbidity & Mortality Weekly Report (MMWR) published by the CDC. Although these data are viewed as inconclusive, Wyeth Lederle is taking the following steps to help answer questions as quickly as possible: Rotavirus causes a highly contagious disease that infects nearly every child by the age of 5. It causes diarrhea, cramps, and vomiting and results in the dehydration and death of approximately 600,000 children worldwide every year. In the United States, rotavirus infects 3.5 million children each year, causing 500,000 doctor visits, 160,000 emergency room admissions, 50,000 hospitalizations, and approximately 20 deaths. RotaShield is currently the only licensed rotavirus vaccine. Wyeth Lederle Vaccines is the vaccine unit of Wyeth-Ayerst Laboratories. Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, and generic pharmaceuticals. American Home Products Corporation is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It also is a global leader in vaccines, biotechnology, agricultural products, and animal health care. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products, and patent, and other risks and uncertainties, including those detailed from time to time in AHP's periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements. For more information, consumers may call the CDC's National Information Hotline at 800-232-2522 (English) or 800-232-0233 (Spanish). CONTACT: Media - Douglas Petkus of Wyeth-Ayerst Laboratories, 610-971-4980; or Lowell Weiner, Ph.D. of American Home Products, 973-660-5013; or Investors - Thomas Cavanagh of American Home Products, 973-660-5706 Company News On-Call: http://www.prnewswire.com/comp/044235.html or fax, 800-758-5804, ext. 044235 |
