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FDA REQUIRES BLACK BOX WARNING ON LEVAQUIN LABEL
FDA notified makers of fluoroquinolone antimicrobial drugs, including Levaquin, for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.
Gadolinium Causes Nephrogenic Fibrosing Dermopathy
Gadolinium Information Gadolinium, or gadodiamide, is used to show contrast between normal tissue and abnormal tissue in the brain and body during the administration of an MRI. It is used in contrast mediums including Omniscan, Magnevist, MultiHance, OptiMARK, and ProHance. Gadolinium looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head causing these abnormal areas to become enhanced on the MRI.
Fleet is linked to a risk of kidney injury called acute phosophate nephropathy
Following the issuance of FDA's safety alert, stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of its over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.
"COURTS EXAMINE LINK BETWEEN DENTURE CREAM AND NEUROLOGICAL DAMAGE"
ABC News has reported that doctors have found a link between the use of certain brands of denture cream and harmful zinc build-up in the body which can lead to serious neurological problems. The Wall Street Journal reports that state and federal courts have begun to examine the link.
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FDA REQUIRES BLACK BOX WARNING ON METOCLOPRAMIDE LABEL
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.
WASHINGTON (AP) -- Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents.
After more than a year of review, Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years. The agency studied several dozen reports of cancer in children taking the drugs, some of which were fatal. Half of the cases were lymphomas, a cancer that attacks the immune system.
The drugs are known as tumor necrosis factor blockers and work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue. The drugs are prescribed to children with rheumatoid arthritis, inflammatory bowel disorder and Crohn's disease.
The FDA will bolster the "black box" warning on the five drugs sold in the U.S., including Abbott Laboratories' Humira, Johnson & Johnson's Remicade and Simponi, and Enbrel which is co-marketed by Amgen Inc. and Wyeth.
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