Class I Recall: Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System (2/4/2010)

The Food and Drug Administration (FDA) and Thomas Medical Products Inc. have notified healthcare professionals of a Class I Recall of certain lots of the Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System, a tube-like device placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels.¹ Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

These devices are being recalled because the sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death. The worldwide voluntary recall is based on 38 reports of tip separation reported via the FDA’s MEDWATCH Adverse Event Reporting program.

FDA Approves Melody Heart Valve (1/25/2010)

The FDA has approved the Medtronic Melody™ Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter and guided up to the heart.² This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open heart surgery. Melody does not cure the heart condition and, over time, may wear and require replacement.

As a condition of the FDA approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two postapproval studies to assess long-term risks and benefits, as well as to evaluate the physician specialization needed to perform the implantation procedure. One study will continue to follow 150 participants from the initial clinical trial for 5 years, and the second study will enroll more than 100 new participants to be evaluated over 5 years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.

FDA Approves New Treatment of Type 2 Diabetes (1/25/2010)

The FDA has approved liraglutide (Victoza®), a once-daily injection to treat type 2 diabetes in some adults.³ Liraglutide is intended to help lower blood sugar levels as an adjunct to diet, exercise, and selected other diabetes medicines; it is not recommended as initial therapy. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is a class of agents that help the pancreas make more insulin after meals.

In 5 clinical trials involving more than 3900 people, pancreatitis occurred more often in patients who took liraglutide than in patients taking other diabetes medicines; the injections should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Liraglutide should be used with caution in people with a history of pancreatitis.

Although liraglutide was not associated with an increased risk for cardiovascular events in people at low risk for these events, the manufacturer is required to conduct a 5-year epidemiological study to evaluate thyroid and other cancer risks, as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. The manufacturer is also required to establish a cancer registry to monitor the rate of medullary thyroid cancer in the United States over the next 15 years.

FDA Adds Cardiovascular Warning to Sibutramine (Meridia®) (1/21/2010)

The FDA has notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine.⁴ Based on the serious nature of the review findings, the FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

• History of coronary artery disease (e.g., heart attack, angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (e.g., > 145/90 millimeters of mercury [mm Hg])

Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions that they may have regarding their treatment.

1. Food and Drug Administration (FDA). Medical Devices. Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion. Updated February 4, 2010.Sideport. Available at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199918.htm. Accessed February 5, 2010.
   
2. Food and Drug Administration (FDA). News & Events. FDA News Release. FDA Approves First Percutaneous Heart Valve. January 25, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198597.htm. Accessed February 5, 2010.
   
3. Food and Drug Administration (FDA). News & Events. FDA News Release. FDA Approves New Treatment for Type 2 Diabetes. January 25, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed February 5, 2010.
   
4. Food and Drug Administration (FDA). Drugs. Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia. January 21, 2010. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed February 5, 2010.