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Xarelto Under Drug Recall Due to Contamination

Janssen Issues Drug Recall for Xarelto After Discovering Contamination

Johnson & Johnson’s pharmaceutical subsidiary Janssen issued a drug recall in mid-October for 13,500 bottles of their controversial blood thinner, Xarelto, after learning of a microbial infection in a sample.

A drug recall notice in the most recent FDA Enforcement Report stated that the pharmaceutical manufacturer discovered a microbial contamination in a sales sample of Xarelto, based on a customer complaint. Although the drug recall is voluntary, it covers all of the United States and its territories. Reportedly, the contaminated sample came from a manufacturing facility in Gurabo, Puerto Rico.

“Janssen is committed to ensuring the quality of its products,” Janssen said in an emailed statement regarding the drug recall for Xarelto. “We received a complaint involving one bottle of a XARELTO sample, and therefore are recalling the entire lot. All XARELTO dosage strengths remain available for patients and product obtained at a pharmacy is not impacted.”

The subsidiary faced a similar problem last year when another controversial drug, Risperdal, fell under a large drug recall after mold particles were found in a sample.

Xarelto Dangerous for Other Reasons

In June of this year, a study from the Institute for Safe Medicine Practices reported that bleeding incidents and adverse events related to Xarelto prescriptions are on the rise. As of 2013, the FDA has received 680 complaints alleging injuries and death from Xarelto.

Xarelto was approved by the FDA in 2011. In the first 3 months of 2012, the blood thinner’s popularity sky-rocketed – around 130,000 prescriptions were written for Xarelto in the US alone. However, some doctors began expressing concern about Xarelto – not only because there is no known antidote, but because, unlike warfarin, the drug has no routine anticoagulant screening to help monitor patients’ safety and prevent internal bleeding or blood clots.

Numerous concerns have been raised about the safety of blood thinners recently – not only Xarelto, but Pradaxa as well, and a long-trusted blood thinner, warfarin. However, warfarin’s blood thinning effects can be countered by administering a dose of vitamin K, to increase the blood’s clotting abilities; there is currently no antidote for Xarelto, and therefore no way to halt bleeding events, making the drug especially dangerous for patients.

The Strom Law Firm Fights for Patients Injured by Dangerous Drugs Like Xarelto

Without routine monitoring and an antidote, Xarelto puts patients at serious risk of life-threatening side effects or event death.

Side effects from Xarelto use can include:

  • Uncontrolled bleeding events
  • Pulmonary embolism
  • Deep vein thrombosis
  • Gastrointestinal hemorrhage
  • Hemoglobin decrease
  • Cerebrovascular accidents
  • Hematoma (collecting or pooling of blood inside blood vessels)
  • Edema peripheral (tissue swelling)
  • Dyspnea (difficulty breathing or shortness of breath)

The products liability lawyers at The Strom Law Firm, LLC are at the forefront of the fight to protect the public and will stand up for your rights against the big drug and insurance companies. We will fight to ensure that you and your loved ones receive the justice you deserve.  Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. 803.252.4800



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