"It is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia," Dr. Karen Midthun,cheap moncler jackets director of FDA's Center for Biologics Evaluation and Research, said in an agency statement. "Pneumococcal disease is a substantial cause of illness and death. Today's approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group."
Prevnar 13 is already sanctioned for use in children aged 6 weeks through 5 years for the prevention of infection with multiple strains of Streptococcus pneumoniae and for ear infections (otitis media) that the bacteria can cause.
FDA's approval of Prevnar 13 for older adults was based on studies conducted in the United States and Europe involving 6,000 people aged 50 and older. Participants received either Prevnar 13 or a pneumococcal vaccine already approved for this age group, called Pneumovax 23.
Approval of Prevnar 13 for older adults is conditional on post-marketing trials aimed at confirming the anticipated clinical benefit, the agency said.
Durezol vs. Durasal: FDA Warns of Drug Name Mix-Up
The U.S. Food and Drug Administration is telling consumers to watch out for any potential mix-up between prescription eye drops and a common wart-removing medication that bear similar names.
According to a warning letter issued this week from the agency, at least one patient has been seriously injured after being given a bottle of the wart remedy Durasal instead of the eye drops called Durezol. And there have been other reports of confusion between the two similarly named but drastically different drugs.
Health care practitioners have also complained to moncler men jackets the agency about the similarity between the two drug names, the FDA said.
Although the FDA routinely screens drug names as part of its approval process, the wart remover Durasal was never required to go through the approval process. According to ABC News, the label on the medication does include the warning "NOT FOR USE IN EYES."
"Health care professionals and patients are encouraged to scrutinize packaging and labeling information carefully," the FDA said.
Elorac Inc., the Illinois-based distributor of Durasal, has not yet responded to inquiries from the FDA regarding the removal of the product from the marketplace or its recall, the agency said.
Los Angeles Voters to Decide on Condoms in Sex Films
Los Angeles residents will have an opportunity during the June presidential primaries to cast a vote on another issue: whether the use of condoms should be mandatory for actors in the area's sex film industry.
According to The New York Times, the AIDS Healthcare Foundation has long been pushing lawmakers to enact such legislation, which would also include fees for inspections aimed at ensuring compliance. The group managed to collect more than 70,000 signatures, many more than were needed to get the measure onto the ballot.
Still, legal hurdles remain, the Times said, with Los Angeles city attorney Carmen Trutanich filing court papers saying that only the state of California would have the authority to adopt the measure. And pornography industry businessman Steven Hirsch, founder of Vivid Entertainment,Moncler Boots - Cheap Moncler Jackets called such laws "unrealistic."