Alerts, Approvals and Safety Changes

 
 
  • Ticagrelor Approved at Last for US Market: FDA After twice postponing a decision on ticagrelor, and asking for additional data, the FDA has made up its mind: the drug will soon be available for US patients.
  • Alert Excess Radiation With CardioGen-82 So far the FDA has received 2 reports of patients who received more than the expected radiation dose from the strontium-based isotope used with this scanner.
  • FDA Approves Oral Anticoagulant Rivaroxaban for DVT Prevention at Surgery Approval of the once-daily oral factor Xa inhibitor, based on the RECORD trials, has been long awaited.
  • Alert Varenicline May Raise CV Events in CVD Patients: FDA The new safety communication states that physicians need to balance known benefits of varenicline--a drug effective in helping patients quit smoking--with the potential risks when deciding to use the drug in patients with cardiovascular disease.
  • Alert IABP, Cannulae, and IVUS Recalls Now Class I: FDA FDA has officially categorized several recent device recalls as class I, indicating the device defects pose a potentially lethal risk.
  • Alert Pioglitazone for 1 Year May Increase Risk of Bladder Cancer In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information.
  • Alert FDA Restricts Use of Simvastatin 80 mg In the SEARCH trial--the basis for the FDA review--52 patients taking the 80-mg dose developed myopathy compared with one patient treated with the 20-mg dose. In addition, 22 patients treated with the high dose of simvastatin developed rhabdomyolysis compared with none treated with the 20-mg dose.
  • Alert FDA Review Concludes: No Cancer Risk With ARBs An FDA review launched in the wake of a controversial 2010 meta-analysis has concluded that the drugs do not pose a cancer risk to patients. The FDA says it conducted a much larger, more comprehensive review of the data to reach its reassuring conclusions. Not everyone, however, is satisfied.
  • Ticagrelor Approved in Canada Health Canada has granted approval to ticagrelor for the secondary prevention of atherothrombotic events in patients with ACS. The FDA has twice postponed a decision on the drug.
  • Alert Boston Scientific iCross IVUS Catheter Recalled The class I recall affects all iCross IVUS catheters distributed in the US, Puerto Rico, Trinidad and Tobago, and the US Virgin Islands.
  • FDA Approves Narrow Everolimus-Eluting Stent The FDA has approved an everolimus-eluting stent for coronaries as small as 2.25 mm in diameter. The same device will be marketed by Boston Scientific and Abbott under the Promus and Xience Nano brand names, respectively.
  • Alert NIH Pulls Plug on AIM-HIGH Trial With Niacin A trial of extended-release niacin on top of statin therapy in patients with a history of CVD, high triglycerides, and low levels of HDL cholesterol has been halted prematurely, 18 months ahead of schedule, because niacin offered no additional benefits in this patient population.
  • Apixaban Approved in Europe for Use After Hip/Knee Surgery This is the first approval of this drug worldwide. It will be sold under the brand name Eliquis.
  • Alert Long-Awaited Rosiglitazone Risk-Management Strategy Released The agency's new risk evaluation and mitigation strategy will require, among other things, special certification for providers who want to prescribe the drug and pharmacies that want to sell it.
  • Alert Mitraclip Recalled Due to Problems With Delivery System There have been three incidents in which a radiopaque ring has become detached when the catheter was withdrawn. One patient has died following surgical intervention to retrieve the ring.
  • Alert Certain Lifeline and ReviveR AEDs Recalled The recall was prompted by rare situations in which the AED cancels the intended shock during the charging process. A software upgrade can solve the problem, the company says.
  • Alert Olmesartan Benefits Outweigh Potential CV Harms, Says FDA In an alert issued today, the FDA said it "has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure."
  • Alert FDA Says Bottled Dabigatran Good for 60 Days Almost two months after heartwirereported on the little-known 30-day expiry date for dabigatran dispensed in bottles, the FDA says its own review suggests the drug maintains its potency for at least 60 days.
  • FDA Approves Azilsartan, Another ARB, for Hypertension The drug will be available in 80-mg and 40-mg doses, although 80 mg is the recommended dose.
  • Alert Lots of Jantoven, other agents recalled Upsher-Smith has expanded its recall from one lot to 16 lots of its Jantoven brand of warfarin sodium and has added lots of amlodipine and other drugs.