Drug Safety

Latest Headlines

Latest Headlines

Questcor comes clean on adverse effects of beleaguered drug Acthar

Questcor is disclosing that its immune-system drug Acthar may pose more risks than it had let on. An SEC filing from Thursday reported that 14% of prescriptions written for the drug in 2013 resulted in adverse side effects, up from 9.1% in 2011.

Merck attacks Italian critic of cholesterol fighter Zetia, then backs off

In February and again in May, Merck sent a cease-and-desist order to Alberto Donzelli, head of education, appropriateness, and evidence-based medicine at Milan's public health authority. Donzelli had openly criticized Merck's cholesterol-lowering drug Ezetrol (ezetimibe), which is sold in the U.S. as Zetia. Now the company is doing an about-face.

Pfizer yanks 220,000 Pristiq bottles on pill mix-up

For the second time in recent months, Pfizer is recalling hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet.

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.