Johnson & Johnson under pressure as FDA approves new use for Xarelto

The Federal Drug Administration approved a new use for the Johnson & Johnson’s prescription drug thinner Xarelto on Monday, but the news failed to boost the pharmaceutical company’s stock as it contends with a massive slate of pending lawsuits.

Officials determined Xarelto can be used to help prevent blood clots in acutely ill patients during and after hospitalization, so long as they aren’t at a high risk of bleeding. The approval could aid demand for the prescription drug, which saw U.S. sales decline about 19 percent to $549 million in Johnson & John’s most recent quarterly earnings report.

The FDA has now approved eight treatment indications for Xarelto, six of which are related to the prevention of blood clots.

Johnson & Johnson shares were flat in trading Monday as legal troubles clouded its financial outlook. The company faces more than 100,000 lawsuits related to allegations of deceptive marketing and unsafe products, according to a Wall Street Journal analysis.

The New Jersey-based firm has been taken to court over its alleged role in the U.S. opioid crisis, as well as over allegations that its talc-based body powders caused cancer in some consumers.

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The company’s latest legal setback occurred last Tuesday, when a Philadelphia jury ruled that Johnson & Johnson must pay $8 billion in punitive damages to a man who said he “developed female breast tissue” after taking the antipsychotic drug Risperdal, the Philadelphia Inquirer reported.

Johnson & Johnson called the verdict “a clear violation of due process” and said it would appeal.

"This decision is inconsistent with multiple determinations outside of Philadelphia regarding the adequacy of the Risperdal labeling, the medicine's efficacy, and findings in support of the company," Johnson & Johnson said in a statement. "We will be immediately moving to set aside this excessive and unfounded verdict."


An Oklahoma judge ordered Johnson & Johnson in August to pay more than $572 million to settle lawsuits related to its alleged role in the state’s opioid crisis.

Johnson & Johnson is set to report third-quarter earnings on Tuesday morning.