Approval of new blood-thinner put on hold
  • Tue, 06/26/2012 - 4:04pm

Pfizer Inc. and Bristol-Myers Squibb struggle to gain FDA approval for blood thinner Eliquis, a drug used to treat heart arrhythmia.
According to the National Heart, Lung, and Blood Institute, a heart that beats too slow, too fast, or irregularly is usually harmless but can be life-threatening if the heart is not able to pump enough blood to the brain and other organs.
Though not requiring further trials, the FDA asked for data clarification from previous Eliquis trials. Unfortunately for Pfizer Inc. and Bristol-Myers Squibb Co., it could take six months to a year to gather this information.
According to Reuters, if Eliquis is approved for stroke prevention, the drug would compete with two other blood clot prevention medications: Xarelto, from Johnson & Johnson and Bayer, and Pradaxa from Boehringer Ingelheim.
All of these blood-thinning drugs are alternatives to warfarin—the original medication that has known risks of serious bleeding. In fact, according to WebMD, all three blood thinning drugs can result in serious side effects, including:

  • Swelling and unusual pain
  • Easy bruising
  • Prolonged bleeding from cuts or the gums
  • Persistent nosebleeds
  • Coughing up blood
  • Bloody vomit
  • Extreme lethargy
  • Headache, dizziness and/or fainting
  • Difficulty breathing and/or swallowing

Because of these serious risks with previous blood-thinners, the FDA is taking the time to further examine Eliquis’ safety and effectiveness before it is approved.


About the Contributor

Kaitlin Gill
I report on news regarding product safety concerns for individuals and families.

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