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Bayer 117 articles

Federal officials crack down on Phillips’ Colon Health for making unsupported claims

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Bayer’s dietary supplement Phillips’ Colon Health is making unsupported claims that it can prevent diarrhea, constipation, gas and bloating but the company does not have reliable scientific evidence to support those claims, according to the Department of Justice. Federal officials took aim at Bayer in a motion filed last week, referencing the company’s multimillion dollar marketing campaigns using both print and television advertisements featuring “the Colon Lady,” who asks people about their colon health. As a result, consumers have spent hundreds of millions of dollars on Phillips’ Colon Health, the motion claims. The government’s crackdown on Bayer stems from a ... Read More

Pharmacy group wants black box warning added to antibiotic Levaquin

black box warning graphic - WL

A University of South Carolina pharmacy group is petitioning the Food and Drug Administration (FDA) to put the strongest warning possible on Johnson & Johnson’s antibiotic Levaquin alerting consumers about the potential for cellular damage that could lead to serious diseases. The Southern Network on Adverse Reactions, a project of the South Carolina College of Pharmacy, says the public should be aware that the antibiotic commonly prescribed to treat infections can damage mitochondria that reside in the cells, resulting in mitochondrial toxicity, which is associated with Alzheimer’s disease, Parkinson’s disease, Lou Gehrig’s disease, and liver damage. Levaquin, also known as levofloxacin, ... Read More

FDA questions value of aspirin therapy for heart attack prevention

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The Food and Drug Administration (FDA) last week denied a request by German drug maker Bayer AG to change the label on packages of its aspirin to promote the benefits of regular aspirin therapy to ward off first heart attack or stroke in people who have never had cardiovascular problems. Now the agency is questioning whether the treatment carries any value to those with no heart issues and whether taking a daily aspirin may actually put these individuals at risk for potentially serious side effects. Aspirin therapy is often recommended for people with cardiovascular disease because it reduces the clotting ... Read More

Cases against Mirena IUD move toward class-action lawsuit

mirena IUD

Months after having the Mirena IUD inserted in her cervix to prevent pregnancy, K. demanded her doctor remove the contraceptive device. It was the only thing she could think of that could be causing her hair loss, weight gain, fatigue, moodiness, and pain during sexual intercourse. She had gotten the intrauterine device six months after delivering her son, but since getting it nothing seemed right. When her doctor went to remove the IUD, he couldn’t find it. K.’s Mirena IUD had dislodged from its intended place in her cervix, perforated her uterus, and migrated into her abdomen, eventually embedding in ... Read More

IUD effectiveness may last longer than advertised

mirena IUD

Intrauterine devices, or IUDs, may be effective at preventing pregnancy longer than advertised, according to a new review of several studies. IUDs are small, T-shaped devices that are inserted into the cervix to prevent pregnancy by either killing or damaging sperm, or by releasing hormones that thicken the cervical mucus and prevent sperm from passing. They are considered the most effective type of reversible contraception compared to birth control pills, implants, patches or condoms. Two types of IUDs sold in the United States include the ParaGard, a copper IUD, and the Mirena, a plastic device that releases the hormone levonorgestrel. ... Read More

$100 million offered to plaintiffs in NuvaRing blood clot lawsuits

NuvaRing - WIKI

Merck & Co. has agreed to pay $100 million to settle thousands lawsuits alleging the company’s contraceptive device NuvaRing caused life-threatening blood clots. The only caveat is that at least 95 percent of the eligible complainants must opt into the agreement otherwise no payouts will be made, a federal judge ruled. The deadline is March 10. U.S. District Judge Rodney Sippel called the settlement “a fair resolution of this litigation.” There are about 3,800 eligible participants in the settlement agreement, which includes more than 1,850 state and federal lawsuits as well as claims that have yet to be filed. NuvaRing is ... Read More

Whistleblower lawsuit against Bayer revived by appellate court

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ST. LOUIS, Mo. – The U.S. Eighth Circuit Court of Appeals restored a whistleblower’s lawsuit against Bayer alleging the pharmaceutical giant fraudulently led the Department of Defense to into purchasing its drug Baycol, a cholesterol-lowering statin that had been linked to 31 deaths. Laurie Simpson, former senior market research analyst for Bayer, filed her lawsuit in a federal court in Minneapolis under the False Claims Act, alleging that Bayer aggressively marketed Baycol in early 1998 to compete with other “cerivastation” drugs when it knew studies had found the drug to be less effective at lowering cholesterol than competing drugs when ... Read More

Mirena IUD complication reports, lawsuits increase

mirena IUD

Women using the Mirena intrauterine device (IUD) for birth control and/or to curb heavy menstrual bleeding should be aware that the devices have been linked to serious injuries. Not only has the Food and Drug Administration (FDA) seen an increase in complaints related to the devices, recent court records show the number of lawsuits alleging injuries due to perforation have risen 17 percent, according to DrugNews, a resource center. DrugNews gives people who use popular prescription drugs or medical devices access to the latest safety alerts, recalls, studies, and legal news. The site recently added a study from the Society ... Read More

Serious injuries associated with Mirena IUD

mirena IUD

Women who are using the intrauterine device Mirena should be aware that the IUD could spontaneously migrate after it is inserted, and may cause serious injury, The Safety Report warns. The Mirena IUD is a birth control device that is also used to treat heavy menstrual bleeding. It is a small, T-shaped device made of flexible plastic that is inserted into the uterine cavity by a trained health care provider. The IUD releases the hormone levonorgestrel to prevent pregnancy. Since the Mirena IUD was approved in 2000, the Food and Drug Administration (FDA) has received numerous reports of adverse events ... Read More

Labor-inducing drug can reduce pain with IUD insertion

mirena IUD

Vaginal administration of a misoprostol tablet four hours before IUD insertion reduces the difficulty and pain associated with IUD insertion in women who have never been pregnant, according to a new study. Misoprostol is a medicine that softens and dilates the cervix, causes uterine contractions and, in pregnant women, induces labor. It is used to treat gastric ulcers caused by non-steroidal anti-inflammatory drugs, to treat missed miscarriage, to induce labor and induce abortion. The study ranged from 2009 to 2011 and involved 179 women who had never been pregnant. Women were randomly given misoprostol or placebo vaginally four hours prior ... Read More