FDA & Prescription Drugs

• Testing Confirms Salmonella In Peanut Butter

  Lee Coleman | February 23, 2007 11:12 AM | 0 CommentsBowling Green, KY

  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...

• Xolair Allergic Reaction Prompts FDA Proposal For Boxed Warning

  Lee Coleman | February 21, 2007 3:24 PM | 0 CommentsBowling Green, KY

  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...

• Oscar Mayer/Louis Rich Chicken Breast Strips Tainted With Listeria

  Lee Coleman | February 19, 2007 3:54 PM | 0 CommentsBowling Green, KY

  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...

• Salmonella Outbreak Linked to Peanut Butter

  Lee Coleman | February 15, 2007 4:19 PM | 0 CommentsBowling Green, KY

  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...

• Rotovirus Vaccine (RotaTeq) Associated With Life Threatening Condition

  Lee Coleman | February 14, 2007 4:40 PM | 0 CommentsBowling Green, KY

  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,...

• New Boxed Warning for Ketek Antibiotic

  Lee Coleman | February 13, 2007 1:43 PM | 0 CommentsBowling Green, KY

  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...

• Aranesp Has High Mortality Rate In New Study

  Lee Coleman | January 29, 2007 4:19 PM | 0 CommentsBowling Green, KY

  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...

• Composix Kugle Mesh Recall Expanded

  Lee Coleman | January 15, 2007 12:28 PM | 0 CommentsBowling Green, KY

  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...

• Cold Medicines Hazardous For Children

  Lee Coleman | January 12, 2007 8:35 AM | 0 CommentsBowling Green, KY

  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,...

• FDA Advisory on MRI Contrasting Agents

  Lee Coleman | December 30, 2006 6:58 AM | 0 CommentsBowling Green, KY

  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...