Drug Safety

Latest Headlines

Latest Headlines

Regado takes a beating as big PhIII study faces safety review

Shares of Regado Biosciences took a nasty beating Thursday evening after the company put out the word that enrollment in its big, self-funded Phase III study of a new anticoagulant had to be put on hold so that a safety monitoring committee could check out "serious adverse events related to allergic reactions."

BMS recalls injectable warfarin, oral formulation unaffected

Bristol-Meyers Squibb recalled six lots of 5 mg single-use vials of Coumadin for Injection due to the presence of particulate matter, but the FDA said the issue does not affect the more prevalent oral formulation of the popular blood thinner.

Biogen MS blockbuster Tecfidera earns high marks for safety

Biogen's multiple sclerosis drug Tecfidera has racked up $1.38 billion in sales since its launch last April, and now the company can claim another feather in the drug's cap: It has the best safety profile of any of its peers. That's the conclusion of a new report out from AdverseEvents, which analyzes side-effects data filed with the FDA.

Affymax, once a promising biotech, is dissolving

Affymax, which 18 months ago appeared poised for big things, is dissolving the company and will pay shareholders pennies for the shares that traded at $27 a share before patient deaths led it to pull its Omontys anemia drug from the market.

Study: Suicides rise in wake of 'black box' warnings on antidepressants

In 2004, the FDA warned the public that antidepressant use could increase the risk of suicidal thoughts or actions in adolescents--and it required all makers of antidepressant drugs to add to the drugs a dreaded "black box" warning. Now a group of researchers from Harvard is presenting rather compelling evidence that the FDA's action might have been a mistake.

Dr. Reddy's initiates 2 recalls even as it invests to remove human error

Execs at India's Dr. Reddy's Laboratories recently highlighted how investments in plant upgrades had taken much of the human involvement out of drug production, but the improvements don't make production fool-proof. The drugmaker is voluntarily recalling a lot of generic Toprol XL as well as an unknown amount of an acid reflux drug it manufactured for someone else.

UPDATED: FDA says compounder making drugs under unsanitary conditions

Last year Alabama-based Medaus Pharmacy withdrew 11 sterile drug products after the FDA raised questions about the lab it was using to test for sterility. The FDA now says the compounder has sterility issues in its own facility which raise questions about the safety of its products.

FDA to vote on opioid-induced constipation pills

The FDA has announced it will vote this week on whether a class of drugs that treat opioid-induced constipation needs more clinical testing in light of a side effect: heart attack. The class of drugs includes recently approved products from Salix Pharmaceuticals and Cubist Pharmaceuticals but also one that AstraZeneca is developing with Nektar Theraputics.

Abbott, AbbVie get to defend testosterone lawsuits on their own turf

Lawsuits have been piling up against Abbott Laboratories and its recent spinoff, AbbVie, maker of one of the top-selling testosterone supplements, AndroGel. A panel of judges has now decided that those suits will be consolidated in Chicago, where both companies are based.

Group again petitions FDA to ban Novo Nordisk's Victoza

While Victoza brought in more than $2 billion last year, it has been dogged by concerns that it raises the risk of pancreatitis--and despite it and other similar drugs being cleared by reviews by both the FDA and EU regulators this year, some keep pushing the FDA to consider pulling it off the market.