Kentucky updates in category: FDA & Prescription Drugs

The annual meeting of the Academy of Neurology in Boston documented the potential dangers of the drug Valproate in unborn children. Researchers say that one in four women who took the drug while pregnant gave birth to children who were mentally retarded, that's double the rate of those who took other epilepsy medications."Dr. Jacqueline French, a professor of neurology at the University of...

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Boston Scientific/Guidant Contack Renewal 3 & 4, Vitality and Vitality 2 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators have been recalled. This is similar to the recall of the May 2006 but the patient outcomes and failure modes are different. Around 73,000 of these are recalled due to faulty capacitors. This may cause accelerated battery depletion and...

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The FDA said today that the Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm. New safety analysis has found a higher chance for stroke, heart attacks, worsening heart chest pain that can become a heart attack. Zelnorm treats irritable bowel syndrome with constipation."The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a...

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Yesterday we told you about the FDA's withdrawal of the drug pergolide sold under the brand Permax. An earlier study published in January in The New England Journal of Medicine shows that Permax and the drug cabergoline (brand name Dostinex) cause the same kind of damage that led to the the recall of the diet drug Fen-Phen. Dostinex is prescribed for a condition called hyperprolactinemia, where...

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The FDA announced today that the manufacturers of pergolide drug products (trade name Permax and two generic versions) will voluntarily remove these from the market. The drug is used to treat Parkinson's disease and may cause serious damage to patients' heart valves. An estimated 12,000 patients received prescriptions for pergolide from pharmacies in the United States in 2006. Patients should...

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Friday the FDA issued strong new warnings for doctors to prescribe carefully in the widely used anemia drugs that could cause serious problems and a risk of death in patients with cancer and kidney disease. The drugs under the brand names of Procrit, Epogen and Aranesp are the ones at issue. Recent studies found the too much of the drugs can cause increased risk of blood clots, strokes, heart...

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The FDA is taking a closer look at the safety of cold and cough medicines for children. They feel the medicines have not been studied enough, especially in those younger than 2 years old. The CDC recently did a study that found more than 1,500 children under the age of 2 had experienced serious health problems, and three had died, all after taking common cold medicines in 2004-05. Taken in high...

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The U.S. FDA confirmed after inspections of ConAgra's plant in Sylvester, Ga. that samples taken from the plant did show the salmonella that sparked the recall on Peter Pan peanut butter and Great Value brand peanut butter. This strain matches what had already been found in jars that were recalled. There have been 370 reported cases of salmonella poisoning in 42 states. But more cases may be...

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The CDC announced yesterday that as of 12 p.m. February 27th, 370 people had been infected with the Salmonella Tennessee from 42 states. Out of 294 that clinical information was available for 60 had been hospitalized for this illness. The dates for the sickness range from August 1, 2006 to February 16, 2007. Most of the illnesses came after December 1, 2006. The recall for the Peter Pan and...

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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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