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New Report Ranks Xarelto, Eliquis & Pradaxa By Safety Profile

Thursday, November 19, 2015

Patents who suffer from the heart irregularity atrial fibrillation, or who are at risk of blood clots after a major surgery, are often prescribed a blood thinner to reduce the risk of stroke.

Three oral blood thinners released between 2010 and 2012 - Pradaxa, Xarelto and Eliquis - have been fighting it out to gain a share of the estimated $6 billion anticoagulant market from warfarin, a drug used since the 1950s.

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FDA Warns Technivie and Viekira Pak May Lead to Liver Disease

Tuesday, October 27, 2015

The U.S. Food and Drug Administration last week issued warnings for the new hepatitis medications, Technivie and Viekira Pak, after noticing an alarming trend of liver side effect reports. Patients taking either drug are cautioned to look for symptoms.

Both drugs are sold by Chicago-based pharmaceutical company Abbvie. Viekira Pak was approved by the FDA in December 2014 and Technivie was approved in July 2015, both for the treatment of hepatitis C.

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Feds Create Special MDL Court For Growing Zofran Lawsuits

Wednesday, October 21, 2015

Earlier this year, DrugNews reported on the growing concern among doctors that Zofran, a drug prescribed off-label for morning sickness in pregnant mothers, might raise the risk of serious birth defects.

Now, amid increased attention and a swell of lawsuits by families whose children have suffered birth defects, a federal panel has created a specialized Zofran multidistrict litigation court (MDL) to handle the cases.

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FDA Approves Pradaxa Antidote After Nearly 1,000 Bleeding Deaths

Monday, October 19, 2015

Last week, the U.S. Food and Drug Administration approved the long-awaited drug Praxbind, which works in most patients to reverse the effects of the powerful blood thinning medication Pradaxa.

The antidote, developed by German drug maker Boehringer Ingelheim, who also makes Pradaxa, was granted fast-track approval by the FDA due to its usefulness in emergency settings for patients afflicted with internal bleeding.

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FDA to Investigate Safety of Antibiotics Cipro, Avelox and Levaquin

Friday, October 09, 2015

Earlier this year, the FDA disclosed it had received more than 1,000 side effect complaints from the often-used antibiotics known as fluoroquinolones - Avelox, Levaquin and Cipro.

These side effects range from psychiatric problems to tendon and nerve damage.

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FDA Panel Questions Safety of Essure Birth Control as Lawsuits Loom

Monday, October 05, 2015

In April, DrugNews reported on an FDA report that noted an increasing number of reported side effects among women fitted with the permanent birth control device Essure.

Last week, a panel of independent doctors questioned both the maker of the device, Bayer, and the FDA, on why and how the device was approved for use and why side effects have spiked. They also laid out a plan for further testing to determine the risk to patients.

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Americans Overpaying for Most Prescription Drugs, Reports Show

Thursday, October 01, 2015

Two new reports out this month have shed light on the hot-button topic of risking drug prices, offering unchallenged proof that we as Americans are getting ripped off and subsidizing treatment for the rest of the world.

As it stands, the prescription drug and medical device lobbying efforts are the largest in the United States, spending more than $250 million each year to try to persuade our lawmakers. And what these companies repeatedly ask for is less legal rights for patients and less regulation on prices.

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FDA Forces New Warning for Zoloft Birth Defect Risks

Wednesday, September 23, 2015

According to recent court filings, the FDA has ordered Pfizer to add new warnings to its popular antidepressant Zoloft that the drug may cause certain birth defects when taken during pregnancy.

The move comes as Pfizer continues to deny their drug poses any risk to fetuses, although they now face hundreds of lawsuits from families alleging birth defects.

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Safety of Eliquis Questioned Due to Missing Clinical Trial Data

Thursday, September 17, 2015

Among the three new generation oral anticoagulants – Pradaxa, Eliquis and Xarelto – released in the past few years to replace the traditional standby warfarin, Eliquis has made the boldest claims about decreasing the risks of stroke, internal bleeding and death.

However, a new report out last month indicates the data relied upon by Pfizer and Bristol-Myers Squibb in making claims about Eliquis’ safety may be flawed. And, at least one FDA reviewer has called for changes to the drug’s label to reflect this.

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FDA Warns of Bone Fractures and Weakness from Diabetes Med Invokana

Wednesday, September 16, 2015

For the past decade, diabetes drugs have been among the best-selling pharmaceuticals in the United States. However, they have also been the subject of frequent safety debates and FDA warnings about patient side effects.

In just the past five years, warnings have surfaced over heart risks for Avandia, bladder cancer for Actos, pancreatitis for Januvia and joint pain for Onglyza and Janumet.

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