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FDA Updates

FDA Issues Warning for Cardiac Nuclear Stress Test Agents


Jan. 8: The FDA is warning that the consumption of more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs that treat constipation can cause rare but serious harm to the kidneys and heart and may result in death. According to the reports that the FDA received, most cases of serious harm involved a single dose of sodium phosphate that was larger than the recommended amount. The FDA urges consumers and health care professionals to “always read the Drug Facts label for OTC sodium phosphate drugs and use these products as recommended on the label, and not exceed the labeled dose.” Previously the FDA warned “about the risk of kidney injury with the use of oral sodium phosphate drug products at higher does for bowel cleansing prior to colonoscopy or other procedures.” Read the full FDA Alert.


Nov. 20: The FDA warned health care professionals of a “rare but serious risk of heart attack and death” associated with use of regadenoson (Lexiscan) and adenosine (Adenoscan). The drugs’ labels are being updated to reflect the risk and revised recommendations for use. According to the warning, these drugs should not be used in patients who show signs of unstable angina or cardiovascular instability since they could be at an increased risk for serious cardiovascular adverse reactions. "[D]ata limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan,” the FDA clarified. Read the full FDA Alert. 

Nov. 15: The FDA alerted health care professionals of the potential for the coating of guidewires manufactured by Medtronic to “delaminate and detach,” which could result in patient injury or death. Nearly 15,000 of the devices were recalled in October after numerous complaints, including a patient injury. “The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices,” noted the FDA. For a complete list of the affected products, read the FDA Alert.

Nov. 6: The FDA issued a Class 1 recall of the TorFlex Transseptal Guiding Sheath Kit, a “single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations.” According to the Agency, “[t]he sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream.” Read the full FDA alert.

Nov. 6: The FDA issued a drug safety communication warning of increased risk for spinal hematomas and paralysis when performing spinal procedures on patients taking low molecular weight heparins. According to the alert, "health care professionals [should] carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures." Labels on low molecular weight heparins will reflect the updated timing recommendations.Read the full FDA alert.

Nov. 4: The FDA issued a Class I Recall for the EMBOL-X Glide Protection System, manufactured by Edwards Lifesciences LLC, due to a “deformed cannula tip.” According to the Agency, “[w]hen force is applied to the tip during insertion or removal, it may lead to a separation and embolize.” The recall impacts model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. All unexpired lot numbers of the EMBOL-X Glide Protection System Cannulae are included in the recall. Read the full safety alert.

Oct. 22: The FDA approved the Diamondback 360 Coronary Orbital Atherectomy System for the treatment of seriously calcified coronary lesions. The system, manufactured by Cardiovascular Systems, Inc., is the first new coronary atherectomy system to be approved in over two decades.

Oct. 21: The FDA cleared Medtronic Inc.’s next-generation Export Advance aspiration catheter. The device “features a pre-loaded stylet - a core wire that runs through the middle of the shaft to provide more support during delivery,” according to a Medtronic press release. “This feature increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.” The device previously received the CE mark in Europe.

Oct. 18: The FDA issued a class 1 recall of Bard Peripheral Vascular Inc.’s LifeStent Solo Vascular Stent, an implantable self-expanding stent and delivery system, as a result of deployment complications including “failure to deploy, partial deployment, and difficult deployment.” According to the FDA, “This product may cause serious adverse health consequences, including possible complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death.” Products manufactured and distributed between November 2011 and June 13, 2012 are impacted. Read the full FDA safety alert.

Oct. 17: The FDA issued a warning for the St. Jude Amplatzer Atrial Septal Occluder, a device used to treat children and adults with an atrial septal defect, due to the potential for tissue erosion. According to the FDA, “in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.” The warning urges health care professionals to read the updated instructions carefully and educate patients about symptoms of erosion so they can be treated immediately. Read the full FDA safety alert.

Oct. 9: The FDA approved riociguat (Adempas) for the treatment of adult patients with two types of pulmonary hypertension. According to the FDA, “It is intended for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension (PAH) of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.” Read the full FDA statement.

Aug. 15: The FDA approved Epaned, a liquid form of the angiotensin-converting enzyme (ACE) inhibitor enalapril maleate, to treat hypertension (high blood pressure) in adults and children over one month old. Until now, enalapril has only been available in adult doses and was adjusted to treat children. The International Pediatric Hypertension Association estimates that up to 5 percent of children and adolescents may suffer from high blood pressure. 

Aug. 8: The Food and Drug Administration (FDA) on Aug. 8 notified health care professionals of a labeling correction for the Optease Retrievable Vena Cava Filter, used to prevent recurrent pulmonary embolism in certain situations. The labeling correction was made “to provide clarification and additional information to minimize likelihood of implanting the filter backwards.” In April, ahead of the FDA’s notification, Cordis Corporation issued an "URGENT Medical Device Correction" to their customers. Read the complete alert.

July 29: The FDA issued a safety alert regarding 21 lots of Nova Max Glucose Test Strips that have been voluntarily recalled by the product’s manufacturer, Nova Diabetes Care, due to the possibility they may “report a false, abnormally high blood glucose result.” According to the FDA, “a false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.” The recall includes Nova Max Plus glucose meter kits that contain test strips from the recalled lots. Read the complete alert.  

July 24: The FDA issued a safety alert for the Albograft Vascular Graft which was recalled by its manufacturer, LeMaitre Vascular, Inc., due to “blood leaking from the surface of the graft after implantation.” Read the complete FDA alert.

July 23: The FDA issued a warning about illegal products on the market that claim to “mitigate, treat, cure or prevent diabetes and related complications.” The FDA has warned 15 companies about their illegal marketing practices and violation of federal law. Any products with labeling that indicates a product “prevents and treats diabetes” or “can replace medicine in the treatment of diabetes” should not be used due to safety issues. “FDA-approved diabetes treatments, prescribed by a licensed health care professional and shown to be safe and effective, are readily available for people with diabetes,” noted the Agency. Read the full safety alert.

June 17: The FDA encouraged medical device manufacturers and health care facilities to have safeguards in place in case of cyberattacks on medical equipment and devices.  While no cases have been reported to date, the FDA noted that the Agency recently became aware of the potential for cybersecurity-related incidents. “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” noted the FDA. “In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.” The FDA is collaborating with other federal agencies and device manufacturers and has released draft guidance for manufacturers that covers cybersecurity and pre-market submissions. Guidance that addresses cybersecurity for products that use off-the-shelf software has also been released. The full FDA safety alert and recommended steps for evaluating your facility’s security are available here

June 12: Warfarin 2 mg tablets (Lot #MM5767) have been voluntarily recalled by Zydus Pharmaceuticals USA Inc. due to a complaint of oversized tablets. “Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin,” according to the FDA’s drug safety alert. “As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal.” Read the complete FDA alert.

May 28: The Nellcor pulse oximetry portfolio—including the NellcorTM Bedside SpO2 Patient Monitoring System, NellcorTM Bedside Respiratory Patient Monitoring System, and NellcorTM N-600x Pulse Oximetry Monitoring System—received FDA 510(k) clearance for Critical Congenital Heart Disease screenings on neonates. Nellcor pulse oximeters, manufactured by Covidien, are the first and only oximeters to comply with ISO 80601-2-61 International Organization for Standardization.

May 24: The FDA issued a Class 1 Recall for Zilver PTX Drug-Eluding Peripheral Stents manufactured by Cook Medical due to complaints of delivery system tip separation. All sizes, diameters and lot numbers prior to April 16, 2013 are impacted. According to the FDA, “potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.” Read the full safety alert.

April 30: The FDA issued a drug safety communication limiting the duration and usage of Samsca (tolvaptan) due to possible liver injury that may result in organ transplant or death. Due to recent clinical trial findings, the Agency warns that patients should not take the drug for longer than 30 days and it should not be used to treat patients with underlying liver disease. Samsca, a selective vasopression V2-receptor antagonist, is used to treat patients with clinically significant hypervolemic and euvolemic hyponatremia, including those with heart failure.

March 27: The FDA issued a Class I recall of Guardian II and Guardian II NC Hemostasis Valves (Model Numbers 8210, 8211, 8215, 8216) manufactured by Vascular Solutions Inc. The Agency notified health care professionals that serious adverse health consequences, including death, could occur due to the potential for an air embolism.  Products that were manufactured and distributed between February 2012 and February 2013 are affected. Ahead of the FDA recall, Vascular Solutions sent an "Urgent Medical Device Recall" notice to its customers warning about the risk. Read the FDA alert.

March 26: The FDA rejected oral treprostinil, a prostacyclin vasodilator, for the second time for the treatment of pulmonary arterial hypertension. The Agency issued a complete response letter to United Therapeutics explaining the rejection. The drug is on the market in injectable and inhalable forms.

March 18: The FDA issued an alert regarding the recall of all products compounded by Med Prep Consulting, Inc. due to "lack of sterility assurance." While all lots of all products have been recalled, the alert stems from mold found in “50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution.” All facilities that have received products compounded by Med Prep Consulting have been contacted by the company and instructed to return products to the pharmacy. Read the full FDA safety alert.

March 12: The FDA issued a Drug Safety Communication announcement regarding the drug azithromycin (Zithromax or Zmax) warning that it may lead to potentially fatal irregular heart rhythm. According to the FDA announcement, patients who are more likely are those with “existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.” Read the FDA’s statement.

Feb. 25: The FDA approved BIOTRONIK's Lumax 740 DX System, a first-of-its-kind single-chamber implantable cardiac defibrillator with “atrial sensing capabilities.” This device allows for the detection of both ventricular and atrial rhythms. Read the press release.

Feb. 13: The FDA approved Medtronic’s Advisa DR MRI SureScan system, an MRI-safe second generation pacemaker system. To date, the first and second generation SureScan systems are the only pacemakers on the U.S. market that are MRI-approved. CMS will only cover MRIs in patients with these approved devices.

Feb. 13: The FDA issued a Class I recall of the St. Jude Medical AMPLATZER TorqVue FX Delivery System due to the possibility of the distal end of the core wire to "fracture when exposed to a combination of certain cardiac anatomies and usage conditions." Use of the system, used in conjunction with the Amplatzer Occluder devices, should be halted immediately. Read the FDA Safety Alert.

Feb. 13: The FDA granted 510(k) clearance to Paragonix for the Sherpa Pak Cardiac Transport System, which uses cold air and oxygenated perfusion to keep hearts alive during transport before transplants. While the system has the potential to keep hearts alive for up to 12 hours, three times the current standard, the FDA only approved the system for up to four hours initially. This approval marks the first advancement in the way donor hearts are transported in years and has the potential to increase the number of heart transplants performed in the U.S.

Jan. 29: The FDA approved mipomersen sodium (Kynamro), an injection that’s paired with lipid-lowering medications and diet for the treatment of homozygous familial hypercholesterolemia (HoFH). HoFH is an extremely rare condition that often causes heart attacks and even death in young patients. Kynamro is an orphan drug approval that is intended to treat fewer than 200,000 people. Read the FDA's statement.

Jan. 25: The FDA approved alogliptin (Nesina), a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes. Additionally, two combination drugs that include alogliptin were approved: alogliptin combined with metformin (Kazano) and alogliptin combined with pioglitazone (Oseni).

Jan. 10: An FDA advisory panel recommended approving canagliflozin (Invokana), a novel type 2 diabetes drug . Part of a class of SGLT2 inhibitors, the drug blocks blood glucose from  being reabsorbed by the kidney, expelling it via urine. If approved, canagliflozin would be the first of its kind on the market. While the panel voted 10-5 in favor of approving the drug, several concerns were raised, including early cardiovascular events and stroke. Several panelists expressed the need for a cardiovascular outcomes study before the drug is approved. The decision will head to the FDA next.

Jan. 3: The FDA approved the XIENCE Xpedition(TM) Everolimus Eluting Coronary Stent System, which is particularily beneficial for patients with complicated coronary anatomies. The XIENCE stents, manufactured by Abbott, are currently the only stents approved for direct stenting in the U.S.