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Has the FDA Made a Recall of Xarelto?

Has The FDA Made a Recall of Xarelto? Xarelto is meant to be an anticoagulant. Within a few hours after taking the medication, patients are supposed to benefit from its effects including blood thinning and the prevention of blood clotting. It is manufactured by Bayer Pharmaceuticals, and marketed by Johnson & Johnson, as noted above. Since its recent ascent into the medical community, it has already attracted much attention and debate. Most of the drama revolves around its murky scientific bases and side effects. Patients have reported frequent problems after taking it, including these:

  • Excessive bleeding
  • Blood clots
  • Wound aggravation
  • Complications with other drugs

The Troubled Cure

Just last year, in October of 2014, Johnson & Johnson was forced to recall approximately 13,000 bottles of a medicine it distributes, known as Xarelto, through a subsidiary company (Janssen Pharmaceuticals). The problem apparently stemmed from of a microbial contamination. Fortunately, no patients or health care professionals have reported falling ill from any contaminated bottle. This is probably in large part due to the fact that the bottles were meant to be samples and not for distribution to pharmacies en route to the general public. The nature of this mistake came to light after the United States Food and Drug Administration (FDA) sent an enforcement letter to Johnson & Johnson.

History With the FDA

This is not the first time that the FDA has put Xarelto under scrutiny. Since 2011, when the drug gained initial approval for marketing and distribution, it has recently questioned claims of its distributor, Johnson & Johnson, or required greater disclosures regarding the medicine. Below is a list of recent actions it has taken with respect to Xarelto:

  • January 2011: The FDA granted approval for Xarelto to be used in hip and knee replacement surgeries for the purposes of preventing embolisms and thrombosis. However, it suggested concerns over its potential damaging effects on internal organs. Also, it questioned the authenticity of Johnson & Johnson's evidence supporting its claims regarding Xarelto.
  • July 2011: The FDA gave three conditions for the marketing of Xarelto. First, create and market a lower-dose Xarelto alternative than was previously available. Second, conduct research to isolate any possible side effects on internal organs after taking Xarelto. Third, investigate any incidents of excessive bleeding as reported by patients for three years.
  • November 2011: The FDA approved the use of Xarelto in non-valvular atrial fibrillation while also cautioning that evidence did not suggest it was any more efficient than existing alternatives.
  • May 2012: The Cardiovascular and Renal Drugs Advisory Committee within the FDA refused to allow Johnson & Johnson to begin marketing Xarelto for broader uses. A significant factor in its decision was its skepticism regarding the sufficiency and sincerity of Johnson & Johnson's supporting evidence.
  • November 2012: Although the FDA found episodes of excessive bleeding common upon the application of Xarelto, it still approved an extension of its use and allowed Johnson & Johnson to begin marketing it for different applications.
  • June 2013: The FDA warned Johnson & Johnson that it had been misleading in two instances of its advertising of Xarelto. First, it minimized the significance and frequency of side effects associated with the drug. Second, it misstated that patients did not have to change the amount of the drug taken for their particular circumstances, when dosage adjustments were actually recommended.
  • January 2014: The FDA forced Johnson & Johnson to include and highlight certain side effects associated with the drug including the following: correlation between Xarelto and spinal surgeries, inability to stop episodes of bleeding, and an uncertainty regarding its effects upon the heart, among others.
  • October 2014: The FDA sent Johnson & Johnson an enforcement letter requiring them to recall over ten thousand bottles of Xarelto because of a microbial contamination.

Recall on the Horizon

Although similar medicines, such as Warfarin, have accomplished the goals of Xarelto without unleashing the same devastating side effects, to date, Johnson & Johnson has refused to completely recall its product. Instead, it has decided to comply with the incremental requests of the FDA in hopes of maintaining market share by adding more and more warnings to its product. However, as an ever-increasing number of patients feel the burn of Xarelto and begin to form complaints against Johnson & Johnson, the day might come when it will be forced to recall this drug or face the music in court.

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