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Food and Drug Administration 233 articles

Recovering Maryland woman sues Bayer after Yaz nearly killed her

Attorneys representing women who have been seriously harmed by Yaz expect that the number of lawsuits against Bayer will escalate dramatically in the coming years, possibly involving thousands of plaintiffs. A 41-year-old writer from Bethesda, Maryland, who is one of the most recent plaintiffs to file a lawsuit against Bayer, recently described her experience taking the drug to the Washington Times. The plaintiff began taking Yaz after her gynecologist reassured her of the drug’s benefits and safety. After weeks of using Yaz, however, the woman began experiencing severe pain that sent her to the emergency room twice for general treatment ... 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The Centers for Disease Control and Prevention recently rescinded its controversial and, some argued, discriminatory requirement that all girls and women ages 11 to 26 immigrating to the United States receive at least one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

Long term use of heartburn drugs can be dangerous

Millions of people turn to medication to treat the annoying and painful symptoms of heartburn. But doctors say that people who use medications to treat their symptoms should use them with caution and limit use if at all possible. One popular choice in acid reflux treatment are pills known as Proton-Pump Inhibitors. “The dark side of Proton-Pump Inhibitors, because we’ve used so much of them for such a long period of time, is beginning to emerge,” says Dr. Henri Roca of LSU Health Sciences Center’s Family and Integrative Medicine during a interview with WWL-TV in New Orleans. Proton-Pump Inhibitors are ... Read More

Reglan may calm chronic sneezing fits, but long-term use risky

Last month, a 12-year-old girl’s mysterious sneezing illness promoted a flurry of attention after her story was told on MSNBC’s Today show. Lauren Johnson sneezes 10 times a minute – up to 12,000 of times a day – and doctors have no clue why. Weeks later she was diagnosed with Paediatric Autoimmune Neuropsychiatric Disorder Associated with Streptoccus, or PANDAS. Her parents say that antibiotics have improved her disorder, but that she is at risk of showing symptoms again in the future. Another chronic sneezer, 22-year-old Caileen Wendel of Pennsylvania, says she sympathizes with Johnson because she has suffered from the ... Read More

Surgical sterilizing, disinfecting system may pose risk to patients

The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff. STERIS Corporation has modified its System 1 Processor, or SS1. The modified version has not been approved or cleared by the FDA, thus the agency has not determined whether it is safe or effective for its labeled ... Read More

Mother says Yaz nearly killed her daughter

A Pittsburgh woman has joined a lawsuit against Bayer, claiming that her teenage daughter was injured and nearly died as a result of taking Yaz. Dana Kraus, the plaintiff, told Pittsburgh’s WTAE that her 15-year-old daughter Katie had been taking the birth control drug for 6 months before she started experiencing severe side effects, which began with the sensation of suffocating. “She was short of breath. She was having severe chest pains and her face was changing colors,” Kraus told WTAE. “She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They ... 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

Cardiac device recalled due to risk of serious injury, death

A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients. The Class 1 recall includes model numbers EC1001 and EC65 of CardioVations EndoClamp Aortic Catheters manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009. A Class 1 recall is the most serious type of recall the FDA can issue and involves situations ... Read More

Bayer tests Google’s new ad format for Yaz promotion

A new ad format developed by Google for prescription drugs attaches a fixed link to sponsored results. When clicked, the link takes the browser to a page announcing  the drug’s side effects, risks, and other important information, much the same way as it is printed on the drug label or inside the product’s packaging. Bayer was the first company to sign up for the new format, which it now uses for its beleaguered birth control pill Yaz. When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear ... Read More