drug safety

Latest Headlines

Latest Headlines

Archives: FDA's safety messages are incomplete

FDA's safety-alert system isn't doing its job. That's what a new Archives of Internal Medicine article contends: The agency's monitoring of its adverse-events database--and publicizing early

In wake of Pallas study, Multaq hopes fade

Earlier this year, a study of Sanofi's atrial fibrillation treatment Multaq was halted because patients on the drug were dying--and suffering strokes and heart failure--at higher rates than...

KV crows over Makena purity as FDA checks claim

Tuesday was a good day for beleaguered KV Pharma ($KV.A), known recently for its he-said/she-said lawsuits with a former CEO and its exorbitant price setting of preterm-birth preventer Makena after

Study: Chantix unsuitable for first-line use

Pfizer's smoking-cessation drug Chantix (varenicline) is not suitable for first-line use due to its poor safety profile, contradicting a recent FDA review, according to a study appearing in the

Boehringer: About 50 deaths in Pradaxa patients

One day after U.K. cost-effectiveness gatekeepers gave a preliminary recommendation for its new blood thinner, Boehringer Ingelheim said about 50 patients using the drug have died since its launch

NEJM study finds no CV risks for ADHD drugs

Some of the cloud hanging over attention deficit hyperactivity disorder drugs has evaporated. A new study published in The New England Journal of Medicine found ADHD drugs didn't increase the risk of

Ranbaxy recalls three drugs for lack of safety warnings

Failure to include updated safety warning information for three drugs has led to Ranbaxy recalls in the U.K. The drugs, which pharmacies have been asked to quarantine, are the antiviral aciclovir,

China assesses illegal drug activities

Six departments within the Chinese government started a nationwide drug safety assessment this week, says the Ministry of Health. Goals include establishing order and curtailing illegal activity as

FDA adds warning to BMS leukemia drug

Bristol-Myers Squibb's ($BMY) leukemia treatment Sprycel has a new warning. In a new safety announcement, the FDA said the drug can increase the risk of pulmonary arterial hypertension (PAH). The

Rx-360 launch reinforces benefits of shared audits

The drug quality and authenticity nonprofit Rx-360 has launched its audit sharing program, through which members collect and share details of their findings from suppliers' investigations. Members