Drug Safety

Latest Headlines

Latest Headlines

UPDATED: FDA returns for look at risk of Boehringer Ingelheim's Pradaxa

FDA and clinical reviews have not found the chances of bleeding to be any greater for Boehringer Ingelheim's Pradaxa than for warfarin, but it continues to top the list for adverse reaction reports, and the FDA has decided to do another data dive into how the two compare.

China clears hep B vaccine makers in child deaths

Chinese regulators do not posses a sterling reputation in their home country, having been caught unprepared as one health scare after another has panicked the population. So when reports began surfacing that children were dying from hepatitis B vaccinations, drug and health regulators sprang into action, launching a probe and putting a hold on millions of doses from the leading hep B vaccine maker.

China probes its largest hep B vaccine maker after child deaths

China, which has been trying to demonstrate adequate oversight of its growing drug industry, is investigating two of its key vaccinemakers after the deaths of 8 children were tied to their hepatitis B vaccines. 

Ariad returns Iclusig to market but with more restrictions and smaller patient pool

Ariad Pharmaceuticals is back in the market with Iclusig. The FDA is allowing the Cambridge, MA-based company to again sell the leukemia drug, but with tighter restrictions to face. Ariad has a lot of ground to regain to return to its former glory.

China rounds up counterfeiters as the FDA boosts its oversight there

After agreeing this month to allow the U.S. FDA to send more people there so it can boost its oversight of drug production, Chinese authorities this weekend reported rounding up 1,300 suspected counterfeiters and confiscating $362 million worth of fake drugs and raw materials.

State AGs lobby FDA to reconsider nod for powerful Zogenix painkiller

The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.

FDA asks Lilly, Zoetis to help it thwart antibiotic resistance

It's well-documented that antibiotic resistance is a growing public health threat. Drug-resistant bacteria infect about 2 million Americans a year, causing at least 23,000 deaths, according to CDC data. Now, to keep resistance from mounting, the FDA is rolling out a plan to cut down on antibiotics use in livestock, enlisting the drugs' producers--companies like Eli Lilly and Zoetis--to help them do it.

UPDATED: FDA still unconvinced on once-rejected diabetes drug from Bristol-Myers, AstraZeneca

AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.

Merck pushes Alzheimer's drug into PhIII trials after clearing a safety hurdle

The pharma giant is recruiting new patients while expanding the program with a new Phase III study for early-stage patients--without changing the dosing regimen.

J&J, Roche, Novartis tout key cancer-drug data at ASH

With the American Society of Hematology meeting in New Orleans, a slew of blood cancer studies are in the spotlight. Three of the releases caught our eye, because they're significant new data on drugs already on the market.