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IN THE NEWS

Invokana Lawsuits Alleging Ketoacidosis On the Rise

Friday, January 22, 2016

Last month, the FDA made news when it announced new warnings about ketoacidosis and urinary tract infections would be added to three diabetes drugs of the SGLT2 class: Invokana, Jardiance and Farxiga.

Now, DrugNews reports that an increasing number of former Invokana patients are filing lawsuits against the maker of the drug, Janssen, after being subjected to ketoacidosis with little or no prior warning from the manufacturer.

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GSK Tries to Quash Fast-Growing Zofran Birth Defect Lawsuits

Tuesday, January 12, 2016

After years of speculation that the popular anti-nausea drug Zofran may cause birth defects when prescribed for pregnancy morning sickness, a federal panel last year created a dedicated court for victims to file claims.

However, as the number of Zofran lawsuits have swelled to several hundred, the maker of the drug, GlaxoSmithKline (GSK), has filed a request to dismiss all claims in an effort to block the rights of families to recover damages.

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Pradaxa Receives Additional FDA Approval Despite Growing Bleeding Lawsuits

Thursday, December 10, 2015

Three novel oral anticoagulant medications – Pradaxa, Xarelto and Eliquis, have battled it out in recent years to grab their share of an estimated $6 billion blood thinning drug market once dominated by the generic drug warfarin.

And while each has promised it is safer and easier to use than warfarin, Pradaxa and Xarelto have been plagued by thousands of reports of patients suffering extended hospitalization or death from internal bleeding. So far, more than 5,000 lawsuits have surfaced alone for Pradaxa bleeding.

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FDA Adds Label Warnings to Diabetes Drugs Farxiga, Invokana, Jardiance

Wednesday, December 09, 2015

The US Food and Drug Administration (FDA) last week added health warnings to the labels of several popular drugs used to treat type-2 diabetes, after reports showed patients may be at risk of high blood acid levels and severe urinary tract infections.

The official label warnings follow a consumer warning issued by the FDA in May when the agency first learned of the ketoacidosis risks.

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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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