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FDA Warns Public of Contaminated Syringes
The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
FDA Issues Early Communication about an Ongoing Review of Vytorin
The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) – on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.
The FDA is informing the public that the agency will conduct a review of Merck and Schering Plough’s recent trial once the FDA receives the final study results.
Merck/Schering Plough Pharmaceuticals issued a press release reporting preliminary results of the study and stated that the study demonstrated no significant differences between the combination product and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. The study was not designed to detect any difference in risk of having a heart attack or stroke between the two treatments. An ongoing trial called -- Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) -- is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke.
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