FDA MedWatch – Synthes USA, Ti Synex II Vertebral Body Replacement – Class I Recall

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall.

FDA MedWatch – MedWatch – Dear Healthcare Professional letter from FDA Commissioner Hamburg re: H1N1 influenza vaccine

A Dear Healthcare Professional letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs, has been released thanking healthcare providers for their efforts during the 2009 H1N1 influenza outbreak. The letter also addresses questions of vaccine safety and availability.

In the letter, Commissioner Hamburg outlines the processes that took the 2009 H1N1 influenza vaccine from creation to manufacture to distribution. We hope this information will be helpful to you when answering questions about the 2009 H1N1 influenza vaccines.

The letter can also be viewed via FDA’s H1N1 website at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm189691.htm

FDA MedWatch – External Biphasic Defibrillators Energy Levels

Devices: External biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).

FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators.

FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised. If you suspect a problem with a defibrillator, such as a situation where a patient received shocks from multiple devices, the problem should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including an link to the Initial Communication.

FDA MedWatch – Edwards Lifesciences CardioVations EndoClamp Aortic Catheter – Class 1 Recall

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice.

FDA MedWatch – Hospira Brand Propofol and Liposyn Products – Recall

Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Stiff Nights (marketed as dietary supplement) contains undeclared drug ingredient sulfoaildenafil

FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

CLICK HERE to read the MedWatch safety summary, including a link to the FDA News Release.

FDA MedWatch – Centurion Medical Products Premie Pack and Meconium Pack

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. These products were distributed from January 1, 2007 through September 22, 2009.

CLICK HERE to read the MedWatch safety summary, including a link to the FDA Class I Recall Notice, at:

FDA MedWatch – Bodybuilding.com Brand Dietary Supplements – Sold on Internet

Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company’s website, www.bodybuilding.com.

FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.
CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Byetta (exenatide) – Renal Failure

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

- Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
- Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
- Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
- Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

CLICK HERE to read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:

FDA MedWatch – Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.