Drug Safety

Latest Headlines

Latest Headlines

Florida man threatened to poison J&J products unless it forked over cash

GlaxoSmithKline announced today that bottles of its alli over-the-counter weight-loss drug were tampered with, and warned consumers to look out for suspect packages.

GlaxoSmithKline flags product tampering as wrong pills surface in alli packages

Some U.S. consumers found the wrong drug when they opened their packages of alli, the GlaxoSmithKline weight-loss pill, the company said. Glaxo is warning alli users to check their packages carefully and avoid taking any pills that might not be authentic.

Contrary to popular belief, side-effect reports on new meds keep a steady pace, study finds

Side-effect reports to the FDA are a contentious subject. Despite a series of efforts to improve adverse-event reporting, numbers from the agency's database tend to be quoted with an accompanying list of disclaimers. But is the Federal Adverse Event Reporting System more reliable than we think?

Oral drugs derived from snail venom could offer less invasive pain management

Researchers have developed the basis for a new class of oral drugs derived from the venom of the cone snail that they say could be used to treat chronic nerve pain with fewer side effects than morphine. 

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.