- Scott Kappes | December 27, 2007 3:18 PM |
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FDA & Prescription DrugsLast night the CBS Evening News featured an interesting story on Pfizer's prescription stop smoking drug Chantix. The story featured an interview with 33 year-old Amy Garza, a 17 year smoker who tried Chantix to help her quit smoking. Garza was initially very pleased with the results she got from the drug and thought she was well on her way to living a smoke-free life, that is until she tried to...
- Scott Kappes | December 21, 2007 4:48 PM |
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FDA & Prescription DrugsToday the FDA issued a public safety warning regarding Johnson and Johnson's Duragesic pain patch and its generic equivalents. This is the second such warning for these devices. Recent reports to the FDA confirm that improper use of the patches is still causing severe adverse reactions and death. In July of 2005 a similar warning was issued for the patch after 120 patients died while taking the...
- Scott Kappes | December 20, 2007 2:59 PM |
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FDA & Prescription DrugsThe Serratia marcescens bacteria infected hospital patients in both Texas and Illinois when contaminated syringes were used to administer medication to them. In all 41 patients have been treated for the infection from the contaminated syringes. Over 20 patents were infected a Rush Medical Center in Chicago and another 20 caught the infection at a Dallas area oncology clinic. Seirra Pre-Filled...
- Scott Kappes | December 18, 2007 12:29 PM |
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FDA & Prescription DrugsLast Friday the FDA issued a warning letter to Wyeth Pharmaceuticals Inc. over an advertisement for Effexor XR published in a professional journal. The FDA states that the letter overstates the efficacy of Effexor XR and makes unsubstantiated claims of the drug's superiority to other treatments. The letter also claims that the ad understates the risks associated with the use of Effexor XR. These...
- Scott Kappes | December 17, 2007 10:01 AM |
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FDA & Prescription DrugsThe European Medicines Agency has decided that Pfizer's smoking cessation drug Champix, marketed as Chantix in the States, needs to include a an updated warning to inform physicians and consumers of the possibility of depression, suicidal thought and even suicide attempts associated with the drug. There have been reports of several suicides and numerous claims of suicidal ideation attributed to...
- Scott Kappes | December 13, 2007 5:20 PM |
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Wrongful DeathThis week Boston plays host to the ICD Lead Performance Conference. This conference is dedicated to the wires that connect implantable cardioverter defibrillators (ICD) to the heart. These little wires were tossed into the public eye back in October when medical device giant, Medtronic, recalled one of its most popular leads due to an elevated risk of breakage. Reports of the defective wires...
- Scott Kappes | December 12, 2007 10:21 AM |
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FDA & Prescription DrugsYesterday the findings of a new study on Avandia out of Canada were published in the Journal of the American Medical Association. The study reaffirms another study published in May of this year demonstrating a link between Avandia and an increased risk of heart attack. The new study was conducted by a non-profit organization looking at over 159,000 older patients with diabetes. All patients...
- Scott Kappes | December 10, 2007 11:59 PM |
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FDA & Prescription DrugsLate last week a Pennsylvania state court judge Richard C. Jackson overturned a $3 million award to a woman claiming that the hormone-replacement drug Prempro caused her breast cancer. The judge declared that she did not show sufficient evidence of negligence on behalf of Wyeth, the maker of the drug. The woman, Jennie Nelson, is appealing the ruling. Nelson was diagnosed in 2001 after taking...
- Scott Kappes | December 10, 2007 3:35 PM |
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FDA & Prescription DrugsAccording to new research from TNS Healthcare's DiabetesDynamics American doctors have made much more significant changes in the way they prescribe Avandia when compared to doctors of Europe. Since the May article linking Avandia to a possible 42 percent increased risk of heart attack 70 percent of prescribing changes have been attributed to withdrawal, or basically doctors switching to another...
- Scott Kappes | December 07, 2007 11:59 AM |
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FDA & Prescription DrugsOn Thursday two pharmacy benefit programs dropped Avandia from their formularies. The controversial move comes in response to safety concerns stemming from a May report linking the drug to a 43 percent increased risk of heart attack. Prime Therapeutics and HealthTrans announced they will no longer allow their customers to purchase Avandia through their programs. The decision is based on careful...
- Scott Kappes | December 06, 2007 11:14 AM |
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FDA & Prescription DrugsAn American Journal of Psychiatry article suggests the smoking cessation drug Chantix may induce manic episodes in patients with bipolar disorder. The article tells the story of a 63 year-old man with a history of bi-polar disorder. The patient had been stable for 5 years while being treated with valproic acid. One week after starting Pfizer's Chantix the man was committed to an inpatient...
- Scott Kappes | December 04, 2007 5:47 PM |
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FDA & Prescription DrugsToday the FDA said the drug, desmopressin, should no longer be used to treat bed-wetting in both children and adults. Reports of seizures and even death have been associated with the drug. Several different companies sell Desmopressin in several different combinations from oral to injectable. Sanofi-Aventis sell several versions under the name DDAVP. The drug limits the amount of water that's...
- Scott Kappes | December 03, 2007 4:16 PM |
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FDA & Prescription DrugsReports have surfaced alleging that the FDA may be considering allowing pharmaceutical companies to market their drugs for uses other than those the drug was approved by the FDA to treat. This is known as off-label promotion. Doctors are allowed to prescribe a drug for whatever purpose they see fit; however, drug companies are not allowed to market drugs for treatments the drug was not approved...