FDA & Prescription Drugs

• Doctors to be Warned About Imaging Agent Risks

  Scott Kappes | October 08, 2007 5:37 PM | 0 CommentsGalveston Bay, TX

  Today it was announced that the FDA will be issuing warnings to doctors about the risks associated with certain imaging agents used to better view the heart in an echocardiograph. The FDA has been investigating reports of serious cardiopulmonary reactions and even deaths associated with the imaging agents. The agents in question are manufactured by Bristol-Myers Squibb Co. under the name...

• Cymbalta Promotion Halted by FDA

  Scott Kappes | October 04, 2007 12:56 PM | 0 CommentsGalveston Bay, TX

  Eli Lilly and Co., the manufacturer of the fast-selling dug Cymbalta has been issued a letter by the FDA ordering them to immediately stop promoting the drug. The FDA claims that a mailer sent out by the company greatly overstates the effectiveness of Cymbalta and conveniently leave out the most serious risks associated with using the drug. Eli Lilly was asked to "immediately cease"...

• Have You Had an Adverse Reaction to Chantix?

  Scott Kappes | October 03, 2007 3:27 PM | 0 CommentsGalveston Bay, TX

  Over the past month since the Carter Albrecht story hit the press there has been plenty of attention paid to the stop smoking aid Chantix. I am sure that most of it is not the kind of publicity that manufacturer Pfizer was hoping for as they launched their new add campaign. Our law office has been contacted by numerous people over the past month with claims of serious adverse reactions to...

• Thousands of Prescription Drugs are NOT Approved by FDA

  Scott Kappes | October 02, 2007 12:53 PM | 0 CommentsGalveston Bay, TX

  I recently read a USA Today article about unapproved drugs on the U.S. market and I was completely blown away by what I found out from it. It turns out that thousands of the drugs that doctors write prescriptions for each day are not approved for sale by the FDA. With all of the controversy and allegations surrounding FDA approved drugs like the recent troubles of Avandia and the colossal...

• "Black Box" warning for Gadolinium Agents

  Scott Kappes | October 01, 2007 11:54 AM | 0 CommentsGalveston Bay, TX

  Last Friday the FDA completed the decision made a few months back to add a "black box" warning to all FDA approved gadolinium containing contrast agents, by issuing a "Dear Healthcare Professional" letter. These contrast agents are commonly used in conjunction with magnetic resonance imaging (MRI) to greatly enhance the image produced by the procedure. These contrast agents however have been...

• Bush signs FDA bill into law

  Scott Kappes | September 28, 2007 4:06 PM | 0 CommentsGalveston Bay, TX

  Yesterday President Bush signed a new bill into law that will give the FDA a much greater ability to police drug companies' actions and drug reactions. This is good news for everyone (maybe not the drug companies), as it will hopefully allow the FDA to solve some of the problems that have been very apparent in recent months and years. The new law will create a registry to allow the FDA to better...

• Cause of Rare Fibrosis Suggested

  Scott Kappes | September 25, 2007 4:54 PM | 0 CommentsGalveston Bay, TX

  Researchers from Wake Forest University have suggested a reason why some people with advanced renal failure develop Nephrogenic Systemic Fibrosis (NSF). Before now there has been no explanation for the rare skin condition characterized by tightening and swelling of skin and in some cases internal tissue and organs. There has been a previous link established between gadolinium based contrast...

• Dietary Supplements Recalled for Potential Health Risk

  Scott Kappes | September 21, 2007 1:54 PM | 0 CommentsGalveston Bay, TX

  Today the FDA issued a nationwide recall of the dietary supplements Axcil and Desirin. These drugs are marketed as dietary supplements but they definitely focus on sexual performance. They were recalled because an FDA laboratory analysis showed that supplements contain potentially dangerous ingredients that are unlisted. The supplements contain sildenafil, the active ingredient in many erectile...

• Chantix and Alcohol: A Deadly Combination?

  Scott Kappes | September 20, 2007 4:42 PM | 0 CommentsGalveston Bay, TX

  The prescription drug Chantix was approved by the FDA last year and has had a great first year for pharmaceutical giant, Pfizer. However, I am sure that the recent attention that Chantix has been getting is not welcomed to say the least. Over the past couple of weeks I have been hearing more and more about Chantix and the implication that it was responsible for Dallas musician Carter Albretch's...

• Cephalon Under Investigation for Off-label Marketing

  Scott Kappes | September 18, 2007 2:42 PM | 0 CommentsGalveston Bay, TX

  The pharmaceutical company Cephalon is under investigation in three separate probes for promoting their drugs for off-label prescription by doctors. Off-label prescribing occurs when a drug is prescribed for a condition that the drug is not intended to treat. This occurs quite often as doctors are allowed to prescribe drugs at their own discretion, but it is illegal for a drug company to promote...