Drug Safety

Latest Headlines

Latest Headlines

UPDATED: GSK recalls more than 425K tubes of antibiotic cream

GlaxoSmithKline set up a dermatology manufacturing center of excellence in the U.K. several years ago. But its manufacturing of its Bactroban products has proven to be less than excellent of late, leading to the recall of more than a quarter of a million tubes of antibiotic cream that may be contaminated.

Study: Pfizer's Chantix does not increase risk of depression, heart attack in smokers

Pfizer has been trotting out positive study data to try to convince the FDA to revoke a black-box warning on its smoking cessation drug Chantix tied to serious psychiatric side effects. Now the company is touting a new study which shows that Chantix does not increase certain cardiovascular or psychiatric symptoms and that it should be recommended for more smokers.

Veterinarian's op-ed piece says antibiotic ban taking tools away from vets

In a recent editorial that appeared in a publication focused on poultry health, a veterinarian cautioned that the movement against using antibiotics and other drugs in production animals is limiting the ability of vets to do their job.

UPDATED: J&J-Bayer and Pfizer-BMS look for marketing advantages in real-world Xarelto, Eliquis data

Johnson & Johnson and Bayer are leading the four-horse race among new-age anticoagulants, and they're hoping some new real-world safety data for Xarelto can help keep the med in the No. 1 spot.

ESC: AstraZeneca gets more backing for long-term Brilinta use

Earlier this year, AstraZeneca touted positive Brilinta (ticagrelor) data from its PEGASUS trial, which found that long-term use of the drug plus aspirin helped prevent heart attacks, strokes and cardiovascular death in post heart-attack patients--and did so better than long-term aspirin plus placebo. And now, AstraZeneca is armed with new details from the study, showing that stopping Brilinta therapy too soon can heighten risks of those very events, helping make the case for long-term use of the drug.

New hurdle for DPP-4 diabetes meds: FDA spotlights risk of 'disabling' joint pain

As if last week's Jardiance news wasn't enough to worry makers of DPP-4 diabetes drugs, the FDA has now issued a warning that the class of meds might cause "severe and disabling" joint pain.

No change in CV risk for ACS patients on Sanofi's Lyxumia

Back in June, researchers unveiled details of the ELIXA trial, which put Sanofi's Lyxumia in the clear as far as cardiovascular safety risks go. Now, a new analysis of the study shows that in Type 2 patients with acute coronary syndrome, the diabetes med didn't increase the rate of cardiovascular events--but it didn't decrease it, either.

UPDATED: It's confirmed: 'No signal' of heart failure risk with Merck's Januvia

The good news keeps rolling in for Merck when it comes to the cardiovascular safety of its DPP-4 inhibitor, Januvia. According to a new analysis of the TECOS trial, patients with Type 2 diabetes and cardiovascular disease--even those with a history of heart failure--can take the drug without an increased risk of CV complications.

Germany lists 54 GVK suspensions as EU comes down on Indian CRO

A few months ago, the European Medicines Agency followed through on a threatened continental marketing halt affecting about 700 drugs in Indian CRO GVK Biosciences' generic lineup due to allegations of manipulated trial results. Now, Germany's regulators have suspended another 54 drugs tested by GVK in accordance with the EMA's recommendations.

Allergan pulls 55 lots of eye drugs after consumers find particulate in their eyes

Allergan Monday said it was going to pull some of its eye drugs from the market because of a problem with particles shedding from the tube cap which led to a "small number of customer complaints." The small number is nearly two dozen, including 12 consumers who said they had a foreign object in their eye as well as one report of swelling and another of blurred vision.