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    Stronger Warnings on 18 NSAIDs After Review Finds Increased Cardiovascular Risk

    The US Food and Drug Administration (FDA) will soon ask drugmakers to update the labels for all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after reviewing mounting evidence linking the drugs to increased risk for heart attack and stroke. In total, drugs containing any of 18 listed active ingredients will be affected by the labeling change, including common over-the-counter (OTC) products such as Advil, Motrin and Aleve, as well as prescription drugs such a...
  • Does Advisory Committee Transparency Lead to Better Regulatory Decision Making?

    The US Food and Drug Administration (FDA) often courts controversy with its decisions to approve or deny new therapies. In the wake of some high-profile scandals in the past decade, the agency has made its regulatory processes more transparent by opening up its advisory committees to more public input and fewer potential conflicts of interest. But, until now, few have asked a simple question: Are those changes leading to improved regulatory outcomes? A new book, Regul...
  • Merck Settles Vioxx Criminal Charges With US for $322 Million

    US pharmaceutical manufacturer Merck & Co. has settled criminal charges over the company's marketing of its painkiller drug Vioxx, reports Bloomberg . Merck will pay a $321.6 million criminal fine after US District Judge Patti Saris approved the settlement. This fine is in addition to a $628.3 million in civil claims paid out in November 2011, reports The Philadelphia Inquirer . Merck was charged with promoting Vioxx, a rheumatoid arthritis drug, illegally despite...
  • NBC Investigation 'Raises Questions About Lax Regulatory Oversight'

    An investigation by Dateline NBC has found that clinical trial compensation in India is often driving economically disadvantaged patients to enroll in the trials regardless of the risks to their own safety. According to the Indian government, more than 1,500 Indians have died as a result of clinical trial participation since 2008. This number is likely far lower than the actual number, as "official documentation of the deaths is frequently incomplete or non-existent," ...