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FDA takes active role in paclitaxel controversy, recalls
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FDA Commissioner Scott Gottlieb, MD, recently announced that he will be stepping down, leaving behind a legacy of great activity during his term.
Among other actions, in the CV world, Gottlieb’s FDA investigated a signal of a link between paclitaxel-coated devices to treat peripheral artery disease and mortality, took a role in reshaping the regulatory landscape for treatment of cardiogenic shock, constantly updated the public on recalls of valsartan and other products, and granted numerous approvals and clearances. Here are some highlights of recent relevant activity by the agency.
Preliminary FDA analysis finds paclitaxel-related mortality signal
An FDA official announced at a special meeting that the agency’s preliminary analysis of the possible link between paclitaxel-coated devices and mortality showed a signal of a link between the two, but no “smoking gun” to provide definitive proof or pinpoint a cause.
Cardiogenic shock: Defining the clinical and regulatory landscape
Clinical experts, FDA and Canadian regulators and industry leaders met to discuss current clinical best practices and brainstorm endeavors to efficiently generate evidence to guide future care of cardiogenic shock — a growing, highly morbid and fatal condition.
FDA clears drug-free test for CAD severity
Abbott announced that the FDA has cleared its diagnostic test that can identify the extent of coronary artery stenosis without the administration of drugs.
Coronary DEB receives breakthrough designation from FDA
MedAlliance SA announced its drug-eluting balloon for treatment of CAD has been given a breakthrough device designation by the FDA.
FDA approves stent platform to treat chronic total occlusions
Medtronic announced that the FDA has approved its drug-eluting stent platform for treatment of de novo chronic total occlusion lesions in patients with CAD.
FDA approves ultrathin bioabsorbable coronary stent
Biotronik announced that a drug-eluting stent system for the treatment of patients with CAD has been approved by the FDA and is commercially available in the U.S.
FDA designates recall of several implanted cardiac pacemakers as class 1
The FDA has designated Medtronic’s product recall of implanted cardiac pacemakers as a class 1 recall, the most serious kind. The recall affects 13,440 devices manufactured and distributed between March 2, 2017, and Jan. 7, 2019.
Valsartan recalls continue as new impurity detected
The FDA has sent out numerous safety alerts between July 2018 and March 2019 that recalls of several drug products containing the active ingredient valsartan, commonly used to treat high BP and HF, are taking place due to detection of impurities.
FDA adds boxed warning to febuxostat for increased mortality risk
The FDA has added a new boxed warning to febuxostat due an increased risk for CV and all-cause mortality compared with allopurinol, according to a recent safety announcement.
Gottlieb leaves mixed legacy on drug prices, opioids, tobacco use
Clinicians, policy experts, medical societies and special interest groups offered a deeper look at how well outgoing FDA Commissioner Scott Gottlieb, MD, followed through on plans to make an impact on drug prices, opioids and tobacco.