FDA & Prescription Drugs

• Additional Contact Solution Recalled

  Staff Writer | November 22, 2006 3:59 PM | 0 CommentsDenver, CO

  FDA's Medwatch announced a recall today of 18 lots of Complete (R) MoisturePLUS multipurpose contact lens care solution and Active Packs which were distributed in the U.S. Certain lots were contaminated with bacteria that compromised sterility, which can carry serious health consequences, including eye infection and microbial keratitis.If you have the recalled product, you should discontinue...

• Flu Vaccine May Cause Dangerous Behavior

  Staff Writer | November 15, 2006 11:10 PM | 0 CommentsDenver, CO

  The FDA has recommended that the label of Roche's popular flu drug, Tamiflu, be updated to carry warnings about possible "neuropsychiatric adverse events," particularly in pediatric patients. The recommendation follows a 10-month review of 103 cases of unsafe behavior, 67 percent of which occurred in pediatric patients. Most of the events, 95 percent, occurred in Japan, which is Tamiflu's...

• FDA Reports New Cases of Rare Neurological Disorder After Administration of Vaccine

  Staff Writer | November 01, 2006 11:14 PM | 0 CommentsDenver, CO

  The FDA and CDC have updated an alert issued last year after receiving more reports of a rare neurological disorder, Guillain Barre Syndrome (GBS) following administration of a vaccine (trade name Menactra) designed to prevent meningococcal disease, a major cause of bacterial meningitis and blood stream infections.To date, a total of 15 confirmed cases of GBS have been reported among individuals...

• More Bad News for Natrecor

  Staff Writer | October 12, 2006 8:25 PM | 0 CommentsDenver, CO

  Two researchers have published data supporting the conclusions reached in their study last year that the heart drug Natrecor (generic name nesiritide) poses an increased risk of death. The study showed that 7.8 percent of patients taking Natrecor died within 30 days of using it; but only 3.9 percent of patients taking other drugs died within the same 30 day period. The study, which was...

• Canadian Web Sites Selling Fake Drugs

  Staff Writer | September 19, 2006 4:16 PM | 0 CommentsDenver, CO

  The FDA is warning people not to buy prescription drugs from certain Canadian web sites that have reportedly sold counterfeit prescription drugs to U.S. consumers. The FDA recommends that people who have bought drugs from the disclosed web sites not use them because they may be unsafe. The FDA reports that lab tests have found counterfeits of the following prescription drugs: Lipitor -- for...

• Study Shows Higher Risk of Fatal Strokes with Lilly's Evista

  Staff Writer | August 23, 2006 11:40 PM | 0 CommentsDenver, CO

  A study involving over 10,000 post-menopausal women over five years has concluded that, although Eli Lilly's osteoporosis treatment Evista reduces the risk of breast cancer, it also brings a 49% higher chance of a fatal stroke. Evista has been associated with an increased risk of blood clots for some time, and the drug maker's label warns of that. But the increased risk of fatal stroke was...

• Ephedra Decision Overturned

  Staff Writer | August 22, 2006 12:27 AM | 0 CommentsDenver, CO

  Nutraceutical Corp. v. Eschenbach, August 17, 2006In this case, the 10th Circuit overturned an order entered in favor of manufacturers of dietary supplements containing ephedra. The 10th Circuit held that the FDA properly carried out its statutory function by determining that there was no safe level of ephedra. What is particularly interesting is that the 10th Circuit commented that the FDA's...

• 10th Circuit Court of Appeals in Denver Rules on Ephedra

  Staff Writer | August 21, 2006 8:12 PM | 0 CommentsDenver, CO

  On August 17, 2006, the 10th U.S. Circuit Court of Appeals in Denver ruled the U.S. Food and Drug Administration correctly followed a mandate from Congress to analyze the risks and benefits of a product; the agency determined that there is no acceptable dosage level of ephedrine-alkaloid dietary supplements. The FDA banned ephedrine-based supplements as of April 12, 2004, after finding that...

• New Legal Setbacks for Merck in Vioxx Trials

  Staff Writer | August 17, 2006 11:15 PM | 0 CommentsDenver, CO

  A federal jury has awarded $51 million to 62-year old Gerald Barnett, a former FBI agent who suffered a heart attack in 2002. Jurors in New Orleans found that Merck & Co. "knowingly misrepresented or failed to disclose" information about Vioxx to Barnett's doctor, who said that if Merck had disclosed the risks associated with Vioxx earlier, he would not have prescribed it for his patient. Mr....

• Drug Companies' Secret Marketing Strategies

  Staff Writer | August 15, 2006 4:20 PM | 0 CommentsDenver, CO

  Documents produced in a 1996 lawsuit have revealed some hitherto little known secrets about how drug companies influence doctors to prescribe their drugs. In addition to mainstream marketing and the very common free lunches provided by drug representatives, MSNBC.com draws on a recent article in the Annals of Internal Medicine to detail insidious, though apparently legal, techniques used to...