InjuryBoard Philadelphia Archives

• More Is Needed To Make Sure Drugs Are Safe

  Jamie Sheller | September 26, 2006 1:21 PM | 0 Comments
  Category: FDA & Prescription Drugs

  According to the Institute of Medicine, needs more resources to track the safety of drugs, once they are approved and marketed. The Institute's report indicates that an imbalance exists between the resources devoted to the pre-approval process for a drug and the resources available to follow drugs after they receive FDA approval. The FDA recognizes that it must do more to improve drug safety. ...

• More Support for FDA Concerns Regarding Ortho Evra

  Jamie Sheller | September 22, 2006 1:13 PM | 0 Comments
  Category: FDA & Prescription Drugs

  One of two epidimiology studies provided support for the FDA's concerns regarding the Ortho Evra birth control patch. The study found that the Ortho Evra patch users had a 2-fold increase in the risk of developing serious blood clots compared to women who used birth control pills. Women with risk factors for blood clots, or those who have concerns, are urged to discuss contraceptive options...

• Panel Recommends Approval For Spinal Replacement Disks

  Jamie Sheller | September 20, 2006 3:28 PM | 0 Comments
  Category: Miscellaneous

  Medtronic received good news when an FDA panel voted to recommend approval for artificial upper spine disks. The stainless steel device is meant to replace degenerating disks in the back. The panel found that in clinical trials, the replacement disks performed at least as well as spinal fusion surgery. However, the panel approval carries several conditions, including more safety studies by...

• Guidant Settles Lawsuit Over Defibrillator

  Jamie Sheller | September 15, 2006 11:51 AM | 0 Comments
  Category: Medical Malpractice

  Recently, the Guidant Corporation settled a lawsuit over one of its cardiac defibrillators. The fraud suit was filed in Texas, and trial was scheduled to start on September 18, 2006. In the lawsuit, plaintiffs Beatrice Hinojosa and Louis Motal claimed that Guidant failed to warn them about the risk of failure for their implanted heart devices. In 2005, Guidant recalled thousands of its...

• New Findings of Vioxx Risk

  Jamie Sheller | September 13, 2006 11:00 AM | 0 Comments
  Category: FDA & Prescription Drugs

  More evidence of the risks of Vioxx was presented by studies recently published online in the Journal of the American Medical Association. The studies produced added information about increased cardiovascular and renal risks with the use of Vioxx. According to the authors of one of the studies, the cardiovascular risks of Vioxx occur at both low and high doses. In addition to the Vioxx risks,...

• Potential Effects of Taking Ibuprofen and Aspirin Together

  Jamie Sheller | September 11, 2006 2:03 PM | 0 Comments
  Category: FDA & Prescription Drugs

  The FDA recommends patient counseling about appropriately using aspirin and ibuprofen together. Use of the two products together may reduce the effectiveness of aspirin taken for cardioprotection and stroke prevention. Studies show that when ibuprofen and aspirin are taken concurrently, "ibuprofen interferes with the antiplatelet activity of low dose aspirin (81mg, immediate release) ..." To...

• Mechanical Heart Approved for Strictly Limited Use

  Jamie Sheller | September 10, 2006 4:18 PM | 0 Comments
  Category: Medical Malpractice

  AbioCor, a fully implantable mechanical heart manufactured by Abiomed, Inc., gained FDA approval for very limited use. "Only patients who have advanced heart failure that has affected the left and right ventricles and who are not candidates for a heart transplant will be eligible to receive the device under the agency's Humanitarian Use Device provisions." The mechanical heart is powered by a...

• Safety Concerns Reported for Coronary Stents

  Jamie Sheller | September 08, 2006 9:16 AM | 0 Comments
  Category: Medical Malpractice

  At a recent European medical meeting, there were several reports about stent safety. Among the safety concerns was information showing increased risk of blood clots with the use of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent. Boston Scientific and Johnson & Johnson are the two biggest stent makers. Stents are used to keep arteries open after blockages are cleared in...

• Dietary Supplements Containing Ephedrine Alkaloids Banned

  Jamie Sheller | September 01, 2006 11:55 AM | 0 Comments
  Category: FDA & Prescription Drugs

  Recently the federal appeals court for the Tenth Circuit "upheld the Food and Drug Administration's (FDA) final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States. . . " The FDA had issued the rule in 2004 after intensively evaluating scientific evidence on ephedrine alkaloids. The sale of any supplements...