FDA & Prescription Drugs

• Pharmacists Care Important to Patients

  Staff Writer | July 06, 2006 9:33 AM | 0 CommentsColorado Springs, CO

  A recent study documents that the quality of care provided by pharmacists is important to the outcome for particular patients. The study, which was conducted on in-patient conditions, determined that the involvement of a pharmacist in patient care is a valuable addition to the patient's health care process. This is consistent with the obligation of pharmacists to do more than "just fill...

• New Rules on Prescription Drug Preemption--FDA's statement and response regarding Comments 12 and 13

  Staff Writer | July 05, 2006 8:47 PM | 0 CommentsDenver, CO

  Comment 12: Some manufacturers expressed concerns that, by highlighting selected information from the FPI to the exclusion of information not highlighted, they make themselves more vulnerable to product liability claims. some of these comments also stated that the highlights limitation statement, which states that highlights do not contain all the information needed to prescribe a drug safely...

• New Rules on Prescription Drug Preemption

  Staff Writer | July 04, 2006 8:44 PM | 0 CommentsDenver, CO

  New FDA labeling regulations were effective June 30, 2006. Announced January 18, 2006, these regulations, 21 CFR 201, 314 and 601, have the claimed purpose of providing new labeling guidelines for prescription drugs, to make drug labeling easier to read and understand and to include requirements to highlight certain information and to promote minor changes in graphics and content of drug...

• Merck Hides Vioxx Clinical Trial Results

  Staff Writer | July 01, 2006 6:38 PM | 0 CommentsDenver, CO

  According to the Associated Press, Merck failed to report to authorities about tests in which users of Vioxx were at greater risk for death then people given placebo. This is according to Dr. Edward Scolnick, the former head of Merck's research laboratories. Dr. Scolnick also testified that in two clinical trials people on Vioxx death was more than two times as likely for those on Vioxx. Merck...

• Ortho Evra Suit Filed

  Staff Writer | June 30, 2006 7:15 PM | 0 CommentsDenver, CO

  On June 30, a new suit was filed against Ortho McNeil Pharmaceutical, Inc., a division of Johnson & Johnson (NYSE:JNJ), on behalf of a 46-year-old woman and her husband. The woman suffered a stroke while using the Ortho Evra(r) Birth Control Patch for only three months. The suit was filed in The Superior Court of New Jersey near Johnson and Johnson's world headquarters.

• FDA Toughens Warnings of Liver Failure on Ketek

  Staff Writer | June 30, 2006 6:20 PM | 0 CommentsDenver, CO

  In its second Safety Information Alert in six months, the FDA announced it is mandating tougher warnings about liver toxicity and liver failure, after receiving reports of four deaths and one liver transplant, in patients who were taking the antibiotic Ketek. Ketek was approved in April, 2004, for upper respiratory infections in adults. The drug's maker, Aventis-Sanofi SA, had been testing the...

• Ketek May Increase Possbility of Liver Injury Four Times Over Other Antibiotics

  Staff Writer | June 30, 2006 5:33 PM | 0 CommentsColorado Springs, CO

  Today the Food and Drug Administration (FDA) warned that use of the antibiotic Ketek could cause dangerous and even fatal liver injury. While all antibiotics carry some risk of liver injury, Ketek appears to be 4 times as likely to cause liver damage as other antibiotics. At least 14 people experiencing liver failure following their use of Ketek, four of which died because of their injuries. 23...

• How Independent is Medical Research?

  Staff Writer | June 30, 2006 9:13 AM | 0 CommentsDenver, CO

  In a recent New York Times story, it was reported that drug companies are pouring large sums of money into medical research through non-profit groups directed by the doctors who are doing the research. In addition, the doctors actually doing the research are often paid consultants to the drug companies themselves. As a result, the risk that drug companies are influencing the direction and...

• FDA Plans Web-Based Reporting for Adverse Events

  Staff Writer | June 29, 2006 9:38 AM | 0 CommentsDenver, CO

  The FDA announced last week that it is developing a single elecronic web-based system for reporting information about drug safety problems. The FDA hopes to have the new system in place within two years, though no firm timetable has been established. "The system will be easy to use, so that the general public is encouraged to report incidents and is not deterred by the nature of the...

• Three Months of Vioxx Use Can Damage Heart

  Staff Writer | June 28, 2006 9:25 AM | 0 CommentsDenver, CO

  The New England Journal of Medicine published a correction June 26, 2006, saying that it does not take 18 months of Vioxx use to increase heart risk, but that heart risks could occur after as few as three months of use. The correction is expected to undermine Merck & Co.'s ability to defend itself against thousands of lawsuits.Dr. Gregory D. Curfman , executive editor of the New England...