Drug Safety

Latest Headlines

Latest Headlines

India's quality lapses sparking turmoil throughout the generic drug industry

India is a crucial player in the global drug supply chain. But there is a growing perception among doctors that Indian-made meds fall short on quality, leading some drugmakers to cry conspiracy and others to wonder how best to respond.

Intercept's lead drug boasts success in PhIII after worrisome side-effects disclosure

Intercept Pharmaceuticals delivered a bad news-good news punch over the weekend about its lead drug.

Shire recalls Gaucher drug but says it has plenty of supply in reserve

Shire is voluntarily recalling three lots of its Gaucher drug Vpriv but emphasized that it does not expect any supply interruption from the recall. Shire has promoted its drug's availability as an indirect selling point against a rival product from Genzyme that ran into supply issues 5 years--a problem the company has long since remedied.

Study finds deaths of Zilmax-fed cattle dwarf Merck's official reports to FDA

As new research findings indicate, the number of U.S. cattle deaths linked to Zilmax could reach into the thousands. That's far higher than the figures Merck reported to the FDA, Reuters reports. And it could seriously interfere with Merck's plans to relaunch the $160 million growth-stimulating drug.

UPDATED: A key Actos trial revs up in Vegas with demands for a $1B-plus judgment

The latest trial over Actos' bladder-cancer risks is set to begin. With thousands of other Actos cases pending against Takeda, the case already was destined to be closely watched. And now, one of the plaintiff's lawyers says he's planning to seek the largest verdict in Nevada history.

UPDATED: Endo finally wins a Low-T drug nod, but safety dispute could snarl its launch

For Endo's testosterone therapy Aveed, the third time wasn't the charm with the FDA--but the fourth time was. After a trio of rejections, the FDA has given the thumbs up to the Low-T drug, and the Malvern, PA-based company expects to launch it this month. But amid the safety questions surrounding testosterone drugs, doing so may not be so easy.

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.