FDA & Prescription Drugs

• FDA Issues Warning For Cold Remedies

  Scott Kappes | January 17, 2008 1:07 PM | 0 CommentsHouston, TX

  Today the FDA issued a warning that parents should not give toddlers over the counter cold and cough medicines. The agency says that these drugs are too dangerous for children less than two years of age. The agency has yet to decide whether OTC cold medications are appropriate for older children, but a decision can be expected in this matter sometime this spring. The warning was prompted by the...

• Supreme Court Refuses To Hear Unapproved Drugs Case

  Scott Kappes | January 16, 2008 2:20 PM | 0 CommentsHouston, TX

  On Monday the United States Supreme Court refused to hear an appeals case involving terminally ill patients' constitutional rights to experimental dugs that have not been approved by the FDA The case was originally filed 2003 when the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs initiated a claim that the FDA's policy of restricting terminally ill...

• Doctors' Group Encourages Vegan Diet Over Avandia

  Scott Kappes | January 15, 2008 5:02 PM | 0 CommentsHouston, TX

  A group of professional doctors has petitioned the FDA to add additional information to the label of the controversial type-2 diabetes drug Avandia. The request may surprise you as it did me. They are not petitioning to place another warning about heart failure or the increased risk of heart attack that has been so widely publicized in recent months, but rather to encourage diabetics to adopt a...

• Judge Overturns Prempro Verdict

  Scott Kappes | December 10, 2007 11:59 PM | 0 CommentsHouston, TX

  Late last week a Pennsylvania state court judge Richard C. Jackson overturned a $3 million award to a woman claiming that the hormone-replacement drug Prempro caused her breast cancer. The judge declared that she did not show sufficient evidence of negligence on behalf of Wyeth, the maker of the drug. The woman, Jennie Nelson, is appealing the ruling. Nelson was diagnosed in 2001 after taking...

• Setback for Celebrex Plaintiffs

  Scott Kappes | November 20, 2007 1:29 PM | 0 CommentsHouston, TX

  Pfizer is breathing a big sigh of relief as a federal judge in San Francisco ruled yesterday that plaintiff's attorneys have not produced reliable evidence that 200mg dosage of the painkiller Celebrex caused heart attacks or strokes. It is currently unclear how many of the 3,000 claims against Pfizer involved the 200mg medium dosage. Regardless how much of dent this places in the legal headaches...

• Marketing Suspended for Bayer's Trasylol

  Scott Kappes | November 05, 2007 2:23 PM | 0 CommentsHouston, TX

  Today the FDA announced that at their request Bayer Pharmaceuticals Corp. has agreed to immediately cease all marketing associated with Trasylol. This comes as a follow up to a report from October 26 that suggested that their may be an increased risk of death connected to the drug used to control bleeding during heart surgery. The preliminary results of a Canadians study on Trasylol suggest this...

• Off-label Prescription of Fentora Linked to Deaths

  Scott Kappes | September 18, 2007 12:25 PM | 0 CommentsHouston, TX

  Last week Cephalon, the makers of the powerful painkiller Fentora issued warning letters to doctors about the risks of prescribing Fentora for off-label uses. The letters comes after four deaths were linked to off-label use of the drug. The labeled use for Fentora is to treat breakthrough pain patients with cancer who are already receiving and are tolerant of opioid therapy. This is where the...

• The Risks of Gadolinium Based Contrast Agents

  Scott Kappes | September 12, 2007 2:49 PM | 0 CommentsHouston, TX

  A rare disease has been linked to gadolinium based contrast agents used to enhance MRI images. Nephrogenic systemic fibrosis (NSF) is a debilitating disease characterized by widespread tissue fibrosis. While it has not been definitively proven that gadolinium agents cause NSF it is estimated that 90-95 percent of NSF cases have received gadolinium agents within a couple of months prior to...

• No Class Action Suit in Vioxx Litigation

  Scott Kappes | September 07, 2007 10:40 AM | 0 CommentsHouston, TX

  Yesterday the New Jersey Supreme Court gave Vioxx maker, Merck a gift. The ruling decertified a class action suit that had been approved by two lower courts. The Court decided that class action was not the appropriate way to deal with the cases brought about on behalf of insurance companies that seek to recoup payments they made for the drug that was recalled in 2004.This is a huge victory for...

• Cardiac event risk in Vioxx user starts soon after use begins

  Christen Wiese | August 07, 2007 11:51 AM | 0 CommentsHouston, TX

  A study done by Dr. David Kerr of Britain's University of Oxford discovered that the increased risk of an adverse cardiac event happened sooner than originally thought for Vioxx users.The original conclusion from a past study conveyed that Vioxx posed a significant cardiovascular threat after 18 months of use. However, the new study published in the New England Journal of Medicine in July 2007...