FDA & Prescription Drugs | InjuryBoard Paducah

One week later after a recall of peanut butter by ConAgra Foods, the CDC said Thursday it has confirmed the presence of the dangerous germ Salmonella. According to a spokesman for the CDC jars from New York, Oklahoma, and Iowa have tested positive. Now comes the part of determining how the salmonella got in the jars. At least 329 people have fallen ill from 41 states since August 2006. The...

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The FDA has announced that there have been continued reports of post-marketing experiences of life-threatening anaphylaxis with Xolair (omalizumab). In 2003 Xolair was approved to treat moderate to severe persistent asthma in adults and adolescents 12 years of age and above who were unable to control their asthma with inhaled steroids. The cases of anaphylaxis was approximately one in a thousand...

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And the list grows for recalls on food! This time the six-ounce packages of Oscar Mayer/Louis Rich Chicken Breast Strips With Rib Meat, Grilled, Fully Cooked, Ready To Eat. The package lot numbers are P-19676 and a use by date of 19 Apr 2007. There were 52,650 pounds of fully cooked chicken breasts produced Jan 9th and sent nationwide to retailers. The U.S. Department of Agriculture found a...

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ConAgra announced the link to certain jars of Peter Pan and Great Value peanut butter after almost 300 people around the country became sick. Lids of jars with a product code beginning in 2111. Some of the people here in our own office had the recalled jars, one actually had it at her desk. About 20% of the ill were hospitalized and there were no deaths associated with the outbreak. Salmonella...

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The FDA issued a Public Health Notification about 28 post-marketing reports of intussusception, which is a potentially serious life-threatening condition. What happens is the intestine gets blocked or twisted. Healthcare professionals and others are encouraged to report any cases of this or any other serious events that may be associated with the RotaTeq vaccine. Parents should report any pain,...

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The FDA and Sandofi-Aventis notified healthcare providers of revisions to the antibiotic. Previously approved indications for bacterial sinusitis and acute bacterial chronic bronchitis were removed because the risk out weighs the benefits. It will still be used for community acquired pneumonia of mild to moderate severity. Stronger warnings were put in place for liver injury, loss of...

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Amgen who makes Aranesp sent a letter out to healthcare professionals about a study it had conducted. The study showed it was ineffective in reducing RBC transfusions in patients with anemia not due to concurrent chemotherapy. It also showed a higher mortality in patients who were receiving Aranesp. This study was done comparing the medication with a placebo. This study was done to establish of...

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The FDA and the company Davol/Bard have issued and expanded recall and withdrawl of the Large Oval Ring and Large Circle Patches. The Composix Kugel Mesh Patch can break, leading to bowel perforations and chronic intestinal fistulae. These are very serious conditions that pose a pronounced health risk to affected patients. Symptoms may include severe pain, nausea, vomiting, or a large bulge at...

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HealthDay reports that U.S. government research shows over-the-counter cold medicines can be deadly and harmful if given to children under the age of 2. The only approved use of over-the-counter cough and cold medicines by the FDA is in children over the age of 2. Studies done in children under the age of 2 have shown the medications are no more effective than a placebo. With those results,...

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The FDA issued a Public Health Advisory on gadolinium based contrast agents. Information has been received about a new disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). This may occur in patients with moderate to end-stage kidney disease after they have had a MRI or MRA scan with the gadolinium based contrast agent. There have been 90 reports of...

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The FDA issued an advisory after a research study in The New England Journal of Medicine found a higher chance of patients treated with Procrit, an erythropoiesis- stimulating agent (ESA) also known as recombinant human erythropoietin, for a combination of hospitalizations, death, and heart attack, heart failure and stroke in those with chronic kidney disease who are not on dialysis. These...

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NBC reports today that millions of Americans could be at risk from some heart stents. The concern is devices called drug-eluting stents (DES). Approximately one million Americans a year have these implanted to treat coronary artery disease. $5 billion a year is generated by the two companies that make them. Doctors are starting to see patients with these type stents suffer from heart attacks...

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Roche Laboratories and the FDA notified healthcare professionals of new revisions to the Precautions/Neuropsychiatric Events and Patient Information sections of prescribing for Tamiflu. Postmarketing reports have been of self injury and delirium with Tamiflu use in patients with influenza. Pediatric patients were primarily the ones reported. Patients with influenza should be closely monitored...

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Perrigo Co. a major manufacturer of store-brand acetaminophen recalled 11 million bottles Thursday after discovering metal fragments may contaminate some of the pills. There were no immediate reports of injuries or illness. The fragments ranged in size from microdots to portions of wire one-third of an inch long. The voluntary recall is a class II recall since it might cause a health problem or...

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The FDA and Roche Diagnostic issued a recall of CoaguChek PT test strips due to a potential for a defect that may cause falsely elevated test results. The test strips are used for people on blood thinners. Roche discovered that when insufficient active ingredient (thromboplastin) is applied to the test strip, it can cause a false elevated result. This can cause an incorrect dose of...

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