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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.