Tagged Articles

U.S. food and drug administration 60 articles

Malaysian government set to vaccinate girls with Gardasil

SM Mohammed Idris, president of the Consumers Association of Penang, recently wrote an opinion piece for the Malaysia Kini website, asking that the government reconsider its decision to vaccinate all 13-year-old girls in the country with Gardasil or Cervarix. According to the column, the country’s Ministry of Health (MOH) will spend RM 150 million annually for the vaccinations, which will affect about 300,000 girls. Idris warns the vaccine is “unnecessary, unscientific and unsafe.” Gardasil, manufactured by Merck & Co., and Cervarix, manufactured by GlaxoSmithKline, are promoted for the prevention of the human papillomavirus (HPV), a sexually transmitted virus linked to ... Read More

Former CDC director to head Merck’s vaccine division, Gardasil

Merck and Co. announced yesterday that Dr. Julie Gerberding, the former director of the U.S. Centers for Disease Control and Prevention, will head the pharmaceutical giant’s vaccine division. Dr. Gerberding served as the CDC director from 2002 to 2009, stepping down when President Barack Obama took office. As head of Merck’s $5 billion global vaccine arm, Dr. Gerberding will likely be responsible for revitalizing Gardasil’s waning sales. Merck won FDA approval for the vaccine in 2007 and immediately launched an aggressive campaign to make Gardasil shots mandatory for school girls as young as 11. However, the ambitious plan ultimately failed, ... Read More

CDC drops Gardasil from list of must-have vaccines for immigants

The Centers for Disease Control and Prevention recently rescinded its controversial and, some argued, discriminatory requirement that all girls and women ages 11 to 26 immigrating to the United States receive at least one injection of Gardasil, Merck’s human papillomavirus (HPV) vaccine. The directive went into effect in July of last year, mandating Gardasil shots for immigrant females despite mounting evidence that the shots could cause serious injury and death. The shots were also required of females who posed no risk of contracting or spreading HPV to the wider population. In determining which vaccines immigrants are required to have, the ... Read More

Despite risks and expense, FDA approves Gardasil for boys

The Advisory Committee on Immunization Practices, which informs the U.S. Food and Drug Administration on vaccine use and policy, declined to advocate for Gardasil’s systematic and widespread use in boys and men. The human papilloma virus, or HPV, does not present the same risks of cancer in males as it does in females, but it can lead to the development genital warts. Although the committee did not press for the use of Gardasil in men, it did advise U.S. doctors to use the vaccine at their discretion. It also recommended that the shot be included in the federally funded Vaccines ... Read More

FDA demands proof that alcoholic energy drinks are safe

The U.S. Food and Drug Administration is cracking down on manufacturers of alcoholic energy drinks, giving them 30 days to provide scientific evidence that their caffeinated crossover beverages are safe. FDA letters went out to nearly 30 manufacturers recently, representing the earliest stages in the government’s efforts to curb what researchers consider a dangerous trend: the mixing of alcohol and caffeine. Twenty-five percent of college drinkers prefer to party with alcoholic energy drinks because the caffeine enables them to keep going and drink more. After Anheuser-Busch and MillerCoors introduced the first caffeine-alcohol hybrids to the market two years ago, the ... Read More

Doctors have obligation to tell former patients about pain pump risks

In light of a recent report released by the U. S. Food and Drug Administration that confirms the link between chondrolysis and pain pump use, Joseph A. Carrese, MD, MPH, an expert in bioethics, has issued an opinion stating that physicians have a responsiblity to inform former patients on whom they used the device of the possible risk. It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.” The opinion addresses the “ethical and professional obligations of orthopedic surgeons to patients who ... Read More

FDA warns consumers about herbal enhancement pills

The U.S. Food and Drug Administration warned consumers yesterday that the dietary supplement Stiff Nights contains sulfoaildenafil, a chemical compound similar to sildenafil, the active ingredient found in Viagra. When combined with prescription nitrates, including nitroglycerin, sildenafil can cause blood pressure to drop dangerously. Stiff Nights is manufactured by Impulsaria LLC of Grand Rapids, Michigan. It is sold in retail stores and on various websites in bottles containing 6, 12, or 30 red capsules. The product is also available in blister packs that contain one or two capsules. According to the product’s website, Stiff Nights “works using natural ingredients to stimulate ... Read More

Tamiflu dispensers cause dosage confusion and errors

The U.S. Food and Drug Administration issued a public health alert Thursday after finding errors with the measurements on the dosing dispenser included in Tamiflu packaging. Tamiflu is the brand name of Oseltamivir, an antiviral prescription drug used to treat people infected with the influenza virus. Produced by Swiss global health care company F. Hoffman-La Roche Ltd., Tamiflu has been used extensively throughout the world during the last decade to help curb the spread of the flu virus within patients. The FDA found that the dosage dispenser in Tamiflu packages have dosage markings in 30, 45, and 60 milligrams (mg). ... Read More

Steering clear of potentially contaminated food

The U.S. Food and Drug Administration announced another massive recall of fresh produce last week, this time for 1,715 cartons of bunched spinach that tested positive for salmonella bacteria in a random test conducted by the USDA. Alarmed by the frequency of foods recalled over bacterial contamination fears, many consumer advocacy groups and legislators have indicted the federal government’s food inspection system, calling for an overhaul of the FDA and USDA systems currently in place. But in an age of mass production and processing that makes cross contamination ever more likely, it’s wise for the consumer to take certain measures ... Read More

California grower recalls salmonella contaminated lettuce

A California produce grower has recalled romaine lettuce that was distributed throughout 29 states, Canada, and Puerto Rico because of salmonella contamination. Tanimura & Antle, Inc. of Salinas, Calif., issued the recall after the Wisconsin Department of Agriculture detected salmonella on the lettuce in a randomized test. Cartons of the lettuce were shipped in bulk “naked” (without packaging), tied with a printed twist tie, or bagged. The lot code on the suspected lettuce is 531380. The lettuce was provided to retail stores, food service companies, and wholesale customers. According to Tanimura & Antle, the lettuce was harvested between June 25 ... Read More