Paul Tassin  |  October 26, 2016

Category: Legal News

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eliquis-bleeding-gastrointestinalPatients relying on Eliquis for anticoagulant treatment will continue to bear a risk of uncontrollable bleeding, following FDA rejection of a proposed antidote.

The proposed antidote, AndexXa, was denied approval by the FDA in August 2016.

According to Eliquis news, the drug was developed by Portola Pharmaceuticals in response to the urgent need for a medication that could temper Eliquis’s anticoagulant effect in patients who begin to bleed.

Eliquis News Not What Company Had Hoped For

The FDA explained the Eliquis antidote denial in a letter to Portola, asking the company to provide the agency with more information about the drug and in particular about its manufacture.

In a conference call with investors, Portola’s CEO William Lis said the company was facing a challenge in trying to understand this new Eliquis news.

Lis anticipates a meeting with agency regulators may be necessary.

The recent Eliquis news may disappoint some patients who have been hoping that the new-generation anticoagulant might soon be able to be kept under control through the use of some complimentary medication.

As things stand now, patients who develop excessive bleeding while on Eliquis will continue to have one less way to get that bleeding under control.

Eliquis, a product of pharmaceutical company Pfizer Inc., is an anticoagulant medication frequently used to reduce the risk of stroke in patients with atrial fibrillation.

It’s also used to treat and reduce the risk of other clot-related complications like pulmonary embolism and deep vein thrombosis in persons who are at particular risk for those conditions, such as patients who recently underwent hip or knee replacement surgery.

Eliquis is one of a new generation of anticoagulants that were developed to finally bring some competition to warfarin, which had been medicine’s go-to anticoagulant since the 1950s.

The new drugs were developed so that they could be administered without the regular blood draws necessary for patients taking warfarin.

But a drawback associated with each of the new drugs is that they were released to the market without any available antidote that could curb their anticoagulant effect in case of emergency.

Patients on warfarin who experience excess bleeding can temper that drug’s anticoagulant effect by administering vitamin K.

But for years, many taking the new anticoagulants have simply had to wait for the drug to wear off naturally and try to control potentially dangerous bleeding some other way.

It wasn’t until October 2015 that an antidote for one of the new-generation drugs finally earned FDA approval.

The new antidote is effective against only one of the new anticoagulants – it does not function as an antidote to Eliquis.

Eliquis Lawsuits

Had the recent Eliquis news been better, it still would have come too late for some Eliquis patients who have already suffered from excessive bleeding that could not be controlled.

Like thousands of other patients who suffered bleeding injuries while on anticoagulant drugs, some Eliquis users have already begun to file pharmaceutical products liability lawsuits against the drug’s manufacturer.

These patients allege the company failed to adequately warn them about the more dangerous aspects of their medications – such as the lack of an effective antidote.

They also argue that the lack of an antidote makes these drugs defective and dangerous products, placing responsibility on the companies’ shoulders for the cases of injury and death that resulted from excessive bleeding.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Eliquis attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Eliquis class action lawsuit is best for you. [In general, Eliquis lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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If you or a loved one took Eliquis (apixaban) and suffered injuries such as uncontrollable internal bleeding, gastrointestinal bleeding, hemorrhaging, kidney bleeding or death, you may have a legal claim. See if you qualify by filling out the short form below.

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