FDA & Prescription Drugs

• Congress Gives FDA More Power to Monitor Drug Safety

  Joe Saunders | September 21, 2007 8:18 AM | 0 CommentsSarasota, FL

  Congress has passed legislation giving the FDA new powers of oversight concerning the pharmaceutical industry including more authority to require changes to drug labels, demand additional safety studies and limit the distribution of medications when safety concerns arise. The new legislation includes an interesting twist in that it may limit protection of pharmaceutical companies for drugs that...

• Evista - New Breast Cancer Drug

  Brenda Fulmer | September 21, 2007 7:00 AM | 0 CommentsPinellas, FL

  The osteoporosis drug Evista® (raloxifene) was recently approved for use to reduce the risk of invasive breast cancers in postmenopausal women who also have osteoporosis or are at high risk for developing breast cancer http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html. The FDA reports that Evista® is only the second drug ever approved to reduce the risk of breast cancer. Tamoxifen® was...

• 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...

• Fentora Deaths Prompt "Dear Doctor" Letters

  Scott Kappes | September 20, 2007 3:48 PM | 0 CommentsHouston, TX

  Cephalon, the makers of the powerful painkiller Fentora issued letters last week reinforcing prescription and dosage information. The so-called "Dear Doctor" letters were sent out in response to the news that four deaths had been linked to the extremely powerful painkilling lozenge. Cephalon could be in store for further labeling revisions in the near future if more cases of this sort are...

• More Claims of Adverse Chantix Reactions

  Scott Kappes | September 19, 2007 4:33 PM | 0 CommentsHouston, TX

  The stop smoking medication Chantix has been getting some unwanted attention recently in the media. Claims of Chantix causing some very strange and intense side effects have been surfacing quite a bit after the Labor Day shooting of Dallas musician Carter Albrecht. His girlfriend's neighbor tragically shot and killed Albrecht after he apparently tried to kick the door in of his house early Labor...

• First Florida Vioxx Trial Underway in Tampa

  Brenda Fulmer | September 19, 2007 1:37 PM | 0 CommentsPinellas, FL

  Jury selection and opening statements have now been completed in the trial of Refik Kozic v. Merck, the first Vioxx case to proceed to trial in the State of Florida. Refik Kozic, a current resident of Jacksonville and a former long-term resident of Tampa, filed his lawsuit against Merck in 2003 for injuries relating to the heart attack that he suffered after ingesting Vioxx daily for 9 weeks. ...

• Fentora Manufacturers Distribute New Warning

  Jamie Sheller | September 19, 2007 11:36 AM | 0 CommentsPhiladelphia, PA

  Earlier this week, Cephalon, Inc., the drug manufacturer of Fentora issued two letters to warn doctors that Fentora has been linked to serious adverse events, including death. Doctors are supposed to use Fentora to treat cancer patients who are experiencing breakthrough pain and are already tolerant to opioid therapy. Cephalon, however, believes that Doctors may have prescribed Fentora to...

• FDA Issues Saftey Alert on Avandia

  Jesse Guerra | September 18, 2007 2:55 PM | 0 CommentsCorpus Christi, TX

  The U.S. Food and drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosigliazone), a drug used to treat type 2 diabetes.Safety data from controlled clinical trials have demonstrated a potentially significant increase in the risk of heart attacks and heart-related deaths in patients taking Avandia. One study reported by The New York Times found that Avandia made...

• 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...

• Off-label Prescription of Fentora Linked to Deaths

  Scott Kappes | September 18, 2007 12:25 PM | 0 CommentsHouston, TX

  Last week Cephalon, the makers of the powerful painkiller Fentora issued warning letters to doctors about the risks of prescribing Fentora for off-label uses. The letters comes after four deaths were linked to off-label use of the drug. The labeled use for Fentora is to treat breakthrough pain patients with cancer who are already receiving and are tolerant of opioid therapy. This is where the...