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Food and Drug Administration 233 articles

Group offers support network for girls injured by Gardasil

Girls who believe they have been harmed by Merck’s human papillomavirus (HPV) vaccine and their families shouldn’t have to feel alone when dealing with the devastating effects many people believe the drug can have, thanks to an international outreach of volunteers who can help answer questions and provide emotional support. The Guardian Angels, a support group encompassing 23 states and eight countries (including the United States), is made up of 42 volunteers who share knowledge and even personal — in some cases tragic — experience with the Gardasil vaccine. “We would eventually like to have a Guardian Angel in every ... Read More

Despite risks, pediatrics group now recommends Gardasil vaccine for boys

The American Academy of Pediatrics (AAP) is now including Gardasil® on its list of recommended vaccines for boys as well as girls, claiming the vaccine can effectively prevent the spread of the human papillomavirus (HPV), which in rare cases can lead to genital warts and cervical cancer. It’s a significant win for manufacturer Merck, which had positioned the vaccine to be its next big moneymaker after it had to pull its blockbuster drug Vioxx from the market in 2004 over safety concerns. Although the AAP has maintained that Gardasil® is appropriate for boys, until now the shot has never been ... Read More

New recommendations for Gardasil vaccine may put boys at risk

Despite outcry from parents of girls who have received the HPV vaccine Gardasil, and criticism about the vaccine’s effectiveness from one of its own creators, this month the American Academy of Pediatrics endorsed its use for boys. This follows a similar recommendation from the Centers for Disease Control and Prevention (CDC). Critics of the vaccine, which has been linked to thousands of complaints of serious adverse side effects, are left to wonder why their voices are not being heard. When it was introduced by manufacturer Merck, Inc., in 2006, Gardasil was marketed as a preventative treatment for cervical cancer. A ... Read More

Overestimating benefits of HPV vaccines could lead to increased risks

A new study published in the Archives of Pediatric & Adolescent Medicine indicates girls who receive HPV (human papillomavirus) vaccines like Gardasil and Cervarix may overestimate the amount of protection the drug offers. According to the report, funded by the National Institutes of Health, some girls think they no longer have to practice safe sex after receiving the vaccination, or that they are protected from all types of HPV or protected from HPV indefinitely. In fact, vaccines such as Gardasil only protect against four of hundreds of types of HPV, and the vaccine’s effectiveness diminishes after about five to seven ... Read More

All-metal hip implant failures demand better review and regulation, legislators say

California Representative Henry Waxman of California and three other House Democrats on the Energy and Commerce Committee have petitioned Committee Republicans to investigate metal-on-metal hip implants, including DePuy’s recalled ASR systems and other possibly faulty medical devices, citing insufficient regulation as the reason why these products may have harmed so many Americans. Mr. Waxman and the other Democrats explained the “unique risks” of metal-on-metal hip implants, which an estimated 500,000 people in the United States have received. About 37,000 of those patients have received one of DePuy’s recalled ASR hip implants, and many of those patients are now suing the ... Read More

Chantix significantly increases cardiovascular risks, according to another new study

Last month, the Food and Drug Administration warned of newly discovered cardiovascular risks associated with Pfizer’s popular smoking-cessation drug Chantix. But it turns out those risks, which include higher occurrence of heart attack and other adverse cardiovascular events in Chantix users with heart disease, pale in comparison to the findings of a larger study that found many of the same risks exist in Chantix patients with no heart disease. The new study, published in the Canadian Medical Association Journal, included the results of 14 random, blinded clinical trials that monitored cardiovascular health in more than 8,000 patients taking either Chantix ... Read More

FDA warns of new heart risks associated with Chantix

For many smokers trying to kick their addiction, the latest news about the dangers of Pfizer’s smoking-cessation drug Chantix presents as a damned if you do, damned if you don’t dilemma. The U.S. Food and Drug Administration issued an alert yesterday, warning that use of the popular drug could lead to increased risk of heart attack and other adverse cardiovascular events. The FDA said that a randomized, double-blind, placebo-controlled clinical trial of 700 smokers were given Chantix or a placebo. All of the participating smokers had been previously diagnosed with heart disease. Although results found the risks to be relatively ... Read More

Chantix suicides and violence much more common, newly found reports show

A senior scientist working for the non-profit Institute for Safe Medicine Practices has discovered that Chantix is a much more dangerous drug than has been officially acknowledged after finding hundreds of serious adverse reactions were reported to the FDA by manufacturer Pfizer Inc. through improper channels. When Thomas J. Moore analyzed data collected from the FDA’s Adverse Events Reporting System (AERS), he found nearly 600 reports of serious adverse reactions, including 150 suicides, were mixed in with 26,000 records of non-serious side effects such as nausea and skin irritations. These “missing” reports, some of which go back to 2006, also ... Read More

Writer urges parents not to make daughters ‘guinea pigs’ for Gardasil

A writer on the blog site buzzle.com, a news and information clearinghouse website, recently posted an article urging parents to use caution when making a choice about the Gardasil vaccine. The mother of an 11-year-old girl, author Anastacia Mott Austin says young girls receiving the human papillomavirus (HPV) vaccine are like “guinea pigs,” because the vaccine has not been properly tested for long-range consequences on a large sample of girls in its target age group. The vaccine is currently recommended by the FDA for girls beginning as young as age 9, through about age 26, for the prevention of cervical ... Read More

Popular weight-loss supplements pose injury and death risks, consumer group warns

The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately, warns Public Citizen, a national non-profit consumer advocacy group based in Washington D.C. The group has petitioned the Food and Drug Administration (FDA) for a ban of the popular drugs, citing evidence that they can cause severe, life-threatening injury to liver, pancreas, and kidneys. Alli and Xenical are forms of orlistat. Xenical contains 120 milligrams (mgs), while Alli, which is available without a prescription, contains half the amount of orlistat. Public Citizen says that the risks of serious injury far outweigh the drugs’ ... Read More