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FDA Withdraws Approval of Four Cholesterol Drugs

Friday, April 29, 2016

The U.S. Food and Drug Administration took the unusual step this week of withdrawing its approval of four medications used to treat high cholesterol, based on studies that show the benefits of the drugs no longer outweighed the risks.

The change will affect drugs containing niacin, also known as vitamin B-3, and/or fenofibric acid, when the medications are combined with statins.

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Second Trial Over Talcum Baby Powder Ovarian Cancer Begins in MO

Thursday, April 14, 2016

Just weeks after a St. Louis jury ordered Johnson & Johnson to pay $72 million to the family of a woman who died of ovarian cancer after years of using the company’s baby powder products, the second baby powder trial in the Missouri court has started.

This week, the trial began in a lawsuit filed by Gloria Ristesund, a woman diagnosed with ovarian cancer after using Johnson & Johnson’s talcum powder products for 40 years.

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FDA Warns of Heart Risks in Onglyza, Nesina Diabetes Drugs

Thursday, April 07, 2016

Two popular type-2 diabetes drugs are in the news after the FDA warned this week that patients taking them may face higher risks of heart failure.

The new warning, issued Tuesday, focuses on the DPP-4 inhibitors Onglyza (saxagliptin), sold by AstraZeneca, and Nesina (alogliptin), sold by Takeda. Together, these drugs are prescribed more than 3 million times each year.

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Judge Rules Essure Birth Control Lawsuits Can Proceed

Tuesday, March 29, 2016

A federal judge this week issued a ruling that pharmaceutical giant Bayer will have to face many of the growing lawsuits alleging its permanent birth control implant Essure caused serious patient side effects.

The decision comes in the wake of other significant Essure news: a recent study showed the FDA had underestimated the number of fetal deaths linked to the devices; and the FDA’s response of ordering new Essure clinical trials and a black box Essure warning label.

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Lawsuit Claim: Xarelto Makers Helped Hide Study Data

Tuesday, March 15, 2016

This past fall, news broke that a study published in the New England Journal of Medicine comparing the safety and effectiveness of Xarelto and warfarin may be tainted due to a faulty measuring device and missing data.

Now, questions are arising about whether the makers of Xarelto, Bayer and Johnson & Johnson, were complicit in keeping the data from the journal’s editors.

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New U.K. Study Aims to Identify Real World Dangers of Invokana

Thursday, March 10, 2016

Last week, DrugNews reported on new warnings from the FDA, European Medicines Agency and consumer group Institute for Safe Medication Practices that the popular diabetes drugs Invokana and Jardiance may increase the risk of ketoacidosis.

Since patients taking the drugs weren’t warned by the manufacturers of these deadly risks before, those diagnosed with ketoacidosis or kidney failure have begun an Invokana class action lawsuit in Canada and are coordinating special lawsuits here in the United States.

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Children's Advil Recalled In Canada Over Dosage Concerns

Friday, February 19, 2016

U.S. drug maker Pfizer announced this week that it was recalling tens of thousands of packages of infant and children’s Advil from store shelves in Canada, after analysis showed ingredient spoiling may lead to higher or lower dosages than intended.

The move comes during the heart of cold and flu season, when parents rely most on the medications to prevent family illness.

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Judge Blocks GlaxoSmithKline's Attempt to Halt Zofran Birth Defect Suits

Thursday, February 11, 2016

Amid increased warnings that the anti-nausea drug Zofran may be linked to serious birth defects when used during pregnancy, a federal panel last year created a special court for victims to seek compensation from the drug’s maker, GlaxoSmithKline.

In January, with hundreds of lawsuits already filed, Glaxo filed a request to have them thrown out of court before families had a chance to prove their case.

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Study Shows Multiple Medication Use Equals Greater Xarelto Bleeding Risks

Monday, February 01, 2016

Experts have cautioned for years that new-generation oral blood thinners like Xarelto may have similar internal bleeding risks as warfarin, the traditional drug they were designed to replace.

And, recent studies show the risks for gastro-intestinal bleeding in particular may even be higher with Xarelto than warfarin.

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Judge Says Avelox and Levaquin Antibiotic Victims Can File Lawsuits

Monday, January 25, 2016

Last May, the FDA warned consumers of a growing trend in nerve damage side effects from the popular antibiotics Levaquin, Avelox and Cipro. The news prompted calls for greater label warnings, an FDA public hearing, and the creation of a special court for victims who hadn’t been properly warned of the risks to file lawsuits.

Now, as the issue of antibiotic nerve damage risks gains greater exposure, the first Levaquin lawsuit has begun and a judge recently cleared the way for more victims to file claims.

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