FDA & Prescription Drugs

• New Rules on Prescription Drug Preemption and Preemption Principles

  Staff Writer | July 06, 2006 8:49 PM | 0 CommentsDenver, CO

  New Rules on Prescription Drug Preemption and Preemption PrinciplesFDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law. Indeed, the Department of Justice (DOJ), on behalf of FDA, has filed a number of amicus briefs making this very point. In order to more fully...

• Ketek Associated with Severe Liver Damage and Death

  Staff Writer | July 06, 2006 7:04 PM | 0 CommentsDenver, CO

  We'd like to alert you to recent developments concerning Ketek, a popular antibiotic marketed by Sanofi-Aventis SA. Ketek has been associated with severe liver damage and death. In April 2004, Ketek was approved for upper respiratory infections in patients 18 years and older. The FDA had rejected the drug in 2001 and 2003, asking for more safety information. Although Sanofi's clinical...

• Fosamax: Bone-Density Drugs Can Kill Jaws

  Staff Writer | July 06, 2006 10:48 AM | 0 CommentsDenver, CO

  According to the Philadelphia Inquirer, dentists are asking patients whether they have used bone-density medications such as Fosamax before treatment or diagnosis. These drugs, known as bisphosphonates, are linking in numerous studies to a condition known as osteoncrosis of the jaw, or a rotting of the jawbone. Osteoncrosis is causing substantial injuries to victims that in some cases many cases...

• 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...

• 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...