Topic:

Drug Safety

Latest Headlines

Latest Headlines

Pradaxa, Xarelto makers dispute purported Eliquis safety edge

Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.

Eliquis earns best safety score in its class in analysis of FDA adverse event reports

What's the safest anticoagulant? According to AdverseEvents, which analyzes and distills data filed with the FDA, that would be Eliquis, the latest entrant into the warfarin alternative market.

UPDATED: Activists urge FDA to slap black-box warnings on lucrative testosterone boosters

Studies are popping up that highlight safety risks associated with testosterone drug use, and the FDA said last month it would reassess the issue after two years of monitoring. But so far, the agency hasn't drawn any conclusions on whether testosterone treatments increase the risk of stroke, heart attack or death--and so a public advocacy group is taking matters into its own hands.

Chelsea wins FDA nod for once-spurned Northera, but success isn't guaranteed

In its second trip through the FDA, Chelsea Therapeutics' antidizziness drug came out a winner, securing approval to fight faintness in patients with a rare disorder, but not without a daunting label and some strings attached.

With rejection, FDA says Durect's pain treatment Posidur needs further safety studies

Durect suffered a regulatory setback with the FDA rejection of its Posidur treatment for postoperative pain.

No FDA love for Xarelto in ACS patients

Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.

Boehringer says it's fighting 2,000 lawsuits over Pradaxa safety

Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.

FDA rejects Durect's pitch to market postoperative pain therapy

The FDA has rejected Durect's pain therapy Posidur, telling the biotech that investigators didn't provide sufficient data to prove that it could be safely administered. And regulators sent Durect back to the drawing board, instructing the company to do additional safety studies if it still wants to seek an approval for the drug, intended to ease postsurgical pain.

AbbVie is hit with 5 lawsuits citing the dangers of its 'low T' drug

Five days after the FDA announced it would investigate the heart and stroke dangers of testosterone-enhancing drugs, 5 lawsuits were filed against Abbott Laboratories and its spinoff AbbVie by men who claimed they suffered heart attacks or strokes after using one of those products, AndroGel.

Oramed touts PhIIa insulin pill study results; analysts say 'Prove it'

Israel's Oramed touted results from a successful Phase IIa trial of its insulin pill, saying the oral Type 2 diabetes treatment is safe and well-tolerated. But since then, some analysts and media outlets have criticized the company for being less than forthcoming about the data.