Clinical Care & Research

(11/04/2009)  --  Pregnant women, who have been among the most vulnerable to serious health problems associated with the novel influenza A (H1N1) virus, can take some comfort in the protection offered by the H1N1 vaccine. Initial results from an ongoing clinical trial sponsored by the NIH's National Institute of Allergy and Infectious Diseases, or NIAID, showed that healthy pregnant women mount a robust immune response after a single dose of the vaccine. More

(11/04/2009)  --  The FDA is revising the prescribing information for the injectable diabetes medication exenatide and the oral diabetes drug sitagliptin phosphate following reports of renal problems associated with exenatide use, as well as reports linking sitagliptin use with pancreatitis. More

(10/30/2009)  --  Vaccine manufacturers are expected to fall well short of having 40 million doses of novel influenza A (H1N1) vaccine available by the end of October, but HHS Secretary Kathleen Sebelius recently told the Senate's Homeland Security and Governmental Affairs Committee that the target likely will be reached in early November. At an Oct. 21 hearing to update the public on federal efforts to manage the spread of H1N1 influenza, Sebelius said problems with vaccine production yield have been resolved and production is increasing. More

(10/27/2009)  --  The CDC's Advisory Committee on Immunization Practices, or ACIP, has recommended against the routine use of quadrivalent human papillomavirus, or HPV, vaccine to prevent genital warts in boys and young men. Instead, the committee voted during its Oct. 21-22 meeting in Atlanta to support the "permissive use" of Gardasil, Merck & Co. Inc.'s quadrivalent HPV vaccine, leaving decisions on whether to immunize males ages 9-26 years who request the vaccine up to their health care professionals. More

(10/21/2009)  --  Vaccination rates among the nation's adolescents showed significant increases in 2008 compared with the previous year, but coverage still is less than 50 percent for three vaccines specifically recommended for preteens, according to recent survey findings from the CDC. More

(10/19/2009)  --  The FDA has expanded its approval of Merck & Co. Inc.'s quadrivalent human papillomavirus, or HPV, vaccine, which is marketed as Gardasil, to include use of the vaccine to prevent genital warts in boys and men ages 9-26 years. The agency also has given a thumbs-up to a bivalent HPV vaccine for girls and young women. More

(10/07/2009)  --  The FDA is alerting physicians about a change in heparin manufacturing that likely will decrease the potency of the widely used anticoagulant by 10 percent. FDA officials said the U.S. Pharmacopeia, or USP, monograph for heparin has been revised, in part, because of product contamination in 2007 and 2008 that was associated with adverse events, including deaths. More