Drug Safety

Latest Headlines

Latest Headlines

How can Pradaxa, Xarelto and Eliquis finally unseat warfarin? Safety data, analyst says

New oral anticoagulants--such as Johnson & Johnson's Xarelto and Boehringer Ingelheim's Pradaxa--have been in fierce competition with one another for awhile now. But they still have a ways to go to displace the old-guard therapy warfarin--and one GlobalData analyst thinks she knows why.

New Hampshire AG launches investigation into opioid marketing

Amid growing backlash from state and local lawmakers over opioid marketing, New Hampshire is cracking down on several companies marketing the drugs, claiming that the drugmakers intentionally exaggerated their products' benefits while downplaying serious risks.

BioClinica buys pharmacovigilance outfit to continue evolution

BioClinica is continuing the rapid evolution that began 18 months ago when its new owners merged it with CCBR-SYNARC. The latest step in the process is the buyout of Synowledge, a provider of pharmacovigilance and regulatory affairs services and accompanying IT support.

3M recalls iodine applicators over possible toxic chemical contamination

Iodine is routinely used on patients ahead of operations to help protect against bacteria contamination. But what if the iodine itself is contaminated with a toxic chemical? That is the issue facing 3M, which is recalling thousands of cases of surgical applicators.

Sun Pharma recalls more than 216,000 bottles after label leaches chemical

Two years ago, Sun Pharma was before the U.S. Supreme Court defending a label for one of its generic drugs against claims that it didn't adequately warn against risks. Now the labels on some of its drugs are creating another kind of problem, leading to a recall of more than 216,000 bottles of drugs.

J&J faces Tylenol lobbying allegations in first case to go to trial over med

New court documents in the first trial over claims that Johnson & Johnson promoted its blockbuster painkiller, Tylenol, without disclosing potentially dangerous side effects show that J&J's McNeil Consumer Healthcare unit planned to lobby government officials to prevent the FDA from implementing safety restrictions, ProPublica reports.

BMJ: New analysis shows increased suicide rates in teens taking GSK's Paxil

GlaxoSmithKline has faced its fair share of scrutiny over a study of its antidepressant Paxil in teenagers, with some experts claiming that the company wrote off harmful side effects linked to the med. Now, a re-analysis of the original study shows that the trial trumpeted Paxil's benefits while downplaying serious side effects including suicide.

Advera Health Analytics: Merck statins linked to more muscle side effects than rest of class

Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.

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.