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Food and Drug Administration 233 articles

H1N1 vaccine coming at pivotal time

“We are now in a position never before experienced in the history of influenza,” said Dr. Margaret Hamburg, Commissioner of Food and Drugs, in a letter to health care providers about the safety and availability of the 2009 H1N1 influenza vaccine. Just as a new and serious virus is spreading widely around the country, causing hospitalizations and deaths, a vaccine is becoming available to help prevent infection and protect the public.” More than 41 million doses of the 2009 H1N1 vaccine have been allocated to the United States for distribution, with more coming available daily. But a gap still remains ... Read More

FDA recalls contaminated lots of anesthetic propofol

A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and ... Read More

Chicago woman sues Bayer over Yaz-related injuries

A Chicago woman who claims she was injured as a result of taking Yaz filed a lawsuit on November 4 against Bayer in the United States District Court for the Northern District of Illinois. According to the lawsuit, the plaintiff started using Yaz in January 2008 and, as a direct result, developed gall stones which led to the removal of her gall bladder. Development of gall stones and gall bladder disease are among the serious risks associated with the oral contraceptive Yaz. The drug has also been blamed for elevating the risk of cardiac arrhythmias and heart attack, stroke, pulmonary ... Read More

Off-label marketing boosts drug company profits

Off-label marketing is an illegal yet commonly employed sales strategy that some big pharmaceutical companies practice to broaden the appeal of a drug and boost sales. One of the most blatant examples of off-label marketing involved Bayer Healthcare’s blockbuster birth control pill Yaz. Bayer promoted the drug as a treatment for premenstrual dysphoric disorder (PMDD) symptoms and to clear up moderate cases of acne when the FDA approved it as birth control only. Bayer stopped the deceptive marketing of Yaz when the FDA cited it for false and misleading advertising. After Bayer was admonished over its Yaz ads, attorneys general ... Read More

Studies reveal parents demand antibiotics less often

The American Medical Association published a study recently that reveals parents don’t demand unnecessary prescription antibiotics for their children as often as they used to. According to the study, doctors wrote 36 percent fewer prescriptions for antibiotics in the treatment of ear infections and other upper respiratory infections in 2006 than they did in 1995. The trend represents a welcome reversal of antibiotic prescription practices that medical researchers say have led to the emergence of virulent antibiotic-resistant bacteria. Therapeutic use of antibiotics in hospitals, as a prophylactic (preventative) measure for travelers, and as placebo are some of the other forms ... Read More

Comedian lampoons the absurdity of drug ads

Writer-comedian Sarah Haskins has produced another segment of her popular satire on Current TV’s Target: Women, this time calling out the absurdity of television advertising in marketing drugs to women. “Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form ... Read More

Injured by Yaz, SC nurse files lawsuit against Bayer

A 33-year-old nurse from South Carolina has filed suit against Bayer Healthcare Pharmaceuticals, charging that Yaz caused her multiple personal injuries. According to a report published by Reuters, the woman received a Yaz prescription from her dermatologist in March 2008 as a treatment for acne. The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA ... Read More

FDA issues authorization for investigational N1H1 drug

Spurred by a request by the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral intravenous drug peramivir for use in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza (swine flu) who are admitted to the hospital. IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is appropriate based on one or more of the following reasons: 1. The patient is not responding to either oral or inhaled antiviral therapy, 2. When ... Read More

Switzerland investigates the death of young Yaz user

A Swiss health agency is investigating the death of a young woman in Switzerland who died while taking Bayer AG’s birth control pill Yaz. Bloomberg reported that Swissmedic (Switzerland’s drug therapy regulatory agency) and an investigative judge are probing the sudden death of the woman, whose autopsy revealed she died from the effects of a pulmonary embolism. Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a ... Read More

Yaz health risks: better safe than sorry?

Bayer Healthcare’s blockbuster drug Yaz has come under fire in recent years for its potential to cause a spectrum of health problems. Bayer has downplayed these serious risks while drawing attention to some of the drug’s other uses as treatments for acne and the emotional and physical symptoms associated with premenstrual dysphoric disorder (PMDD). Adding to the confusion is a series of clinical tests designed to quantify the drug’s safety risks. Results of the studies have both supported cast doubt on the claims of women who say they have been harmed by Yaz. With your health and possibly your life ... Read More