FDA & Prescription Drugs

• Lipitor: Pfizer Patent May Be Cut Short

  Staff Writer | August 03, 2006 11:11 PM | 0 CommentsDenver, CO

  According to Reuters, a federal appeals court may cut short the patent expiration date for Pfizer's blockbuster drug, Lipitor. The U.S. Appeals Court cancelled one of the two patents in the case, which may result in Lipitor's patent expiration date moving up from June 2011 to March 2010.A brand name drug will usually lose 80% of the market when generic drugs become available. Pfizer stands to...

• FDA Reports Eli Lilly Used Misleading Marketing

  Staff Writer | August 02, 2006 10:59 PM | 0 CommentsDenver, CO

  The FDA accused Eli Lilly and Co. of "misleading" marketing, issued a formal warning letter, and asked them to stop publishing and distributing a brochure about the drug Alimta. If Lilly does not resolve the issue the FDA may decide to impose various penalties on the company. Federal officials reported that Lilly "omits material facts and risk information essential to the safe and effective use"...

• Study: Heart Damage a Result of Cancer Drug Gleevec

  Staff Writer | August 02, 2006 10:41 PM | 0 CommentsDenver, CO

  According to the AP, a study indicates that the popular drug Gleevec (Glivec) may cause severe heart problems, including congestive heart failure. While the report, by Dr. Thomas Force a professor at a Medical College in Philadelphia, indicates significant heart damage can occur while using Gleevec, Force contends that this study is only a warning to doctors and consumers of the potential...

• Jaw Disease Possibly Related To Fosamax

  Staff Writer | August 02, 2006 8:53 AM | 0 CommentsDenver, CO

  According to a report in the Dallas Morning News, medical specialists met to determine the effect of Fosamax and other osteoporosis medication on the jaw bone. In 2003, doctors first began seeing patients develop osteonecrosis of the jaw while using Fosamax and other similar drugs. Since then, over 400 other instances have been reported to medical journals. Osteonecrosis in the jaw is very...

• Taskforce Advises Caution Following Drug Trial Disaster

  Staff Writer | August 01, 2006 10:39 PM | 0 CommentsDenver, CO

  According to a report by ABC News, a joint taskforce, set up by the British Pharmaceutical Industry and BioIndustry Association, advised on new procedure to protect patients during drug trials, following a devastating trial that injured six people. The drug trial of TGN 1412, manufactured by the company TeGenero, shocked the community and pharmaceutical industry when it left six men critically...

• "Unconventional" Lyme Disease Treatment May Be Fatal

  Staff Writer | July 31, 2006 10:37 PM | 0 CommentsDenver, CO

  According to the AP, the FDA warned July 21, that an unconventional treatment for Lyme disease could cause serious injury and even death. Alternative health physicians and others purporting to be doctors prepare and inject into patients a mixture known as bismacine or chromocine, which contains large amounts of heavy metal bismuth. At least one person died while using this product and others...

• Prescription Drug Giant Crosses Ethical Boundaries

  Staff Writer | July 21, 2006 5:56 PM | 0 CommentsDenver, CO

  According to a report by NEWS.com, Roche, a large prescription drug manufacturer, crossed an ethical boundary when it treated hundreds of doctors to expensive meals at some of Australia's most exclusive restaurants. One of these meals cost more than $65,000 USD as Roche paid the bill for over 200 cancer specialists to eat at the Guillaume at Bennelong, and exclusive restaurant inside the famous...

• Ketek's Approval Worried FDA Officials

  Staff Writer | July 20, 2006 5:54 PM | 0 CommentsDenver, CO

  In recent weeks, dozens of e-mails between internal FDA officials were turned over to the New York Times. The e-mails show that at least four FDA officials had serious reservations about the safety of the popular antibiotic, Ketek, which was recently forced to change its label to include stronger warnings. Dr. David Graham, part of the FDA's drug safety office, wrote in a message dated June 16...

• Warning: Roxane Labs Recall Lot 558470A of Azathioprine

  Staff Writer | July 19, 2006 7:28 PM | 0 CommentsDenver, CO

  According to a recent article on Yahoo! News, the producer of Azathioprine, Roxane Laboratories, Inc., on June 13, 2006, announced a recall across the United States and Puerto Rico of Azathioprine tablets, manufacturing lot 558470A. Azathioprine helps to prevent the rejection of kidneys following kidney transplants and in some cases helps treat severe rheumatoid arthritis. The recall is...

• "Black-Box" Antidepressant Warning Still Debated

  Staff Writer | July 19, 2006 6:32 PM | 0 CommentsColorado Springs, CO

  According to a report by the United Press International, the debate continues over the antidepressant's "black box" label, warning of the increased risk for suicidal thoughts and behavior, especially among adolescents. Supporters of the warning see it as necessary and are upset that some doctors are needlessly prescribing these treatments to children. Critics of the warning believe that it...