• Regulatory NewsRegulatory News

    FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi

    Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients. Viberzi is approved by FDA for use in adults for the treatment of irritable bowel syndrome with diarrhea. From May 2015, when Viberzi was first approved, through February 2017, FDA says it received 120 reports of serious cases ...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...
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    OTC Opioid Overdose Antidote: Why is it not FDA Approved?

    The case of the opioid overdose antidote naloxone (also known as Narcan) offers an interesting look at how states can offer a prescription drug without a prescription at local pharmacies, even though the US Food and Drug Administration (FDA) has not approved it as an over-the-counter drug. Prescription opioid overdose deaths in the US are now the leading cause of injury death – surpassing motor vehicle crashes. And between 2000 and 2014, the rate of deaths from drug over...
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    FDA Warns of Medical Device Coating Separation Issues

    The separation of coatings on certain intravascular medical devices has the potential to cause serious injuries to patients, the US Food and Drug Administration (FDA) warned on Monday. FDA is trying to make health care providers aware that patients could be at risk if the hydrophilic and/or hydrophobic coatings separate (e.g., peel, flake, shed, delaminate, slough off) from devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheat...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

    • 03 February 2012
    The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier's anti-diabetes drug Mediator, according to Reuters . Mediator has been blamed for over 500 deaths in France, and was on the market for more than 30 years. After its introduction to the market in 1976, it was prescribed to nearly 5 million French citizens before it was recalled from the market in late 200...
  • After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

    Pakistan is facing calls from industry for a drug regulatory authority to be formed after a batch of cardiac drugs given to patients at a government-run hospital has been linked to more than 100 deaths. Patients at the Punjab Institute of Cardiology were given one or more drugs manufactured by relatively small, local companies . The drugs, given to roughly 40,000 patients, generated side effects that were initially confused with dengue fever. Almost 250 patients remai...