From Medscape Medical News >
FDA Safety Changes: Actonel, Gardasil, Myfortic
Yael Waknine
September 2, 2009 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to warn of the potential for osteonecrosis of the jaw in patients receiving risedronate sodium and other bisphosphonates, the potential for syncope after administration of a human papillomavirus vaccine, and the risk for pure red cell aplasia in patients receiving immunosuppressive treatment with mycophenolic acid delayed-release tablets.
HPV Vaccine (Gardasil) May Be Linked to Postinjection Fainting Episodes
The FDA approved in July safety labeling revisions for human papillomavirus (HPV) quadrivalent recombinant vaccine (Gardasil; Merck and Co, Inc) to warn of the potential for syncope.
Syncope, sometimes associated with tonic-clonic and other seizure-like activity, has been reported after administration of the HPV vaccine. Because fainting can result in falling and injury, patients should be observed for a 15-minute period after receiving the vaccine and encouraged to remain seated or lying down for this length of time.
The FDA notes that when syncope is associated with tonic-clonic movements, the activity is usually transient and typically passes when patients adopt a supine or Trendelenburg position.
The quadrivalent vaccine is indicated for use in girls and young women aged 9 through 26 years for the prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and certain dysplastic lesions caused by HPV types 6, 11, 16, and 18.
Gardasil Prescribing Information
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