Thoratec Corporation has recalled its Implantable Ventricular Assist Devices (IVAD) catalog number 10012-2555-001, serial numbers 488 or higher. The recalled devices were manufactured and distributed from October 1,2 004 through October 22, 2007. These IVAD's are used to help pump blood through the body of a person whose body is too weak to perform that function. The IVAD can be implanted or...
Over 12,000 Tubes of Age Intervention Eyelash Product were seized by U.S. Marshalls this week. The eye product was promoted to increase eyelash growth. Jan Marini Skin Research, Inc. of San Jose, California sold and distributed the product. Although Age Intervention Eyelash product can be purchased without a prescription, it contained active ingredients that required FDA approval to market. ...
Earlier this week, the FDA issued new warning labels to Procrit, Epogen, and Aranesp. These drugs are used to increase hemoglobin levels in patients with chronic renal failure and cancer. Changes to the warnings for patients with cancer include a risk of shortened survival and tumor progression when the dosage reaches a certain level. The warning changes for patients with chronic renal...
Cefepime, marketed as Maxipime, is manufactured by Bristol Meyers Squibb. A recent study of this drug has raised concerns about the increased mortality rate associated with its use. Based on this study, the FDA has begun a safety review which will not be completed for another four months. Cefepine or Maxipine is an antibioltic used for patients who have infections of the ear, chest, skin,...
Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...
The FDA recently announced that GlaxoSmithKline, the manufacturer of Avandia, will be changing its boxed warnings to include the risk of heart attacks. Avandia is a drug used to treat type 2 diabetes. Studies have shown that people with type 2 diabetes who have an underlying heart disease or are at an increased risk of heart attacks while using this medication. For more information view the...
Last week, Merck & Co. agreed to a $4.85 Billion settlement with thousands of plaintiffs. Over the past few years, plaintiffs who were suffered significant injuries caused by Merck's powerful painkiller Vioxx. This settlement is to compensate those victims and put an end to another round of trials by other plaintiffs. Not surprisingly, as part of the settlement agreement Merck did not admit...
Memorials for loved one who suffered an untimely loss are now commonplace throughout highways, and city streets. While some may find comfort in these markers of a life remembered, others may find it morbid and depressing. What are some of options for balancing these competing interests. Should lawmakers place restrictions on the memorials such as the length of the display, what can be...
Cargill Inc. said Saturday, November 3, that it is recalling more than 1 million pounds of ground beef because it may be contaminated with E. coli bacteria.The ground beef was produced between Oct. 8 and Oct. 11 at Cargill Meat Solutions' plant in Wyalusing, Pa. and distributed to retailers across the country. They include Giant, Shop Rite, Stop & Shop, Wegmans and Weis.The problem was found...
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