Posts tagged drug products

• Ketek Significantly Increases Risk of Liver Disease

  Joe Saunders | September 13, 2007 5:43 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Ketek, an antibiotic used for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis, has been shown to cause severe liver injury. Health Canada, in its September 2007 edition, has documented the risk of liver damage for users of the drug. The FDA should recall Ketek as a dangerous drug. Its risks significantly outweigh its...

• Wyeth Facing 3 More HRT-Induced Breast Cancer Survivors

  Brenda Fulmer | September 10, 2007 9:54 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Jury selection will begin on September 10, 2007, in the latest round in the HRT litigation involving Wyeth. Pfizer was also a defendant in the case, but, according to Bloomberg, settled with the plaintiffs in late August. This trial involves the claims of three Nevada women, one of whom is terminal, who developed breast cancer after taking the combination hormone replacement therapy drugs...

• Off-Label Drug Promotion - New Litigation Frontier?

  Brenda Fulmer | September 10, 2007 8:41 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Schering-Plough is now facing eight lawsuits in coordinated federal MDL proceedings in Newark. These lawsuits follow a plea agreement in which the company agreed to pay $435 million to settle criminal and civil charges stemming from its improper, off-label marketing programs and payment of "kickbacks" to prescribing physicians. The pending lawsuits involve several popular Schering-Plough drugs:...

• Questions Surrounding Drug-Coated Stents Persist

  Brenda Fulmer | September 10, 2007 7:51 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Patients who received drug-coated stents after a heart attack are nearly five times more likely to die within 6 to 24 months afterwards when compared to patients who received older "bare metal" stents according to a recent study presented at the European Society of Cardiology meeting in Vienna last week. This study analyzed 2,300 patients in 14 countries who are included in the GRACE Registry...

• Vioxx Class Action Rejected

  Brenda Fulmer | September 10, 2007 6:32 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  The New Jersey Supreme Court rejected a request by a union health plan to certify a national class action lawsuit against Merck on September 6, 2007. The claims were brought under New Jersey's consumer fraud statutes by a union health plan on behalf of health insurers who paid for Vioxx prescriptions. The class had been previously certified by Judge Higbee, the New Jersey state court judge who...

• Gadolinium Linked to Nephrogenic Systemic Fibrosis

  Staff Writer | September 04, 2007 8:31 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Gadolinium is used in magnetic resonance imaging (MRI) dyes to enhance test results. However, the FDA has found that the gadolinium-based dyes are linked to nephrogenic systemic fibrosis, a sometimes fatal that involves the skin, muscle, and internal organs. According to the FDA advisory, signs of dangers include: For the skin--burning or itching, reddened or darkened patches; and/or skin...

• Supplement Manufacturers Will Have to Comply with More Stringent FDA Regulations

  Joe Saunders | August 29, 2007 1:44 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The FDA has published a final rule establishing good manufacturing requirements for the manufacturers of supplements. The rule requires that all supplement manufacturers evaluate the identity, purity, quality, strength, and composition of dietary supplements. In addition, they are required to provide accurate labeling information on all their products. The FDA ruling is supposed to protect...

• Drug Patch Dangers Often Minimized

  Staff Writer | August 29, 2007 12:32 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  The popularity of drug patches has led consumers and some health providers to ignore strong warnings about their side effects, even the lethal dangers associated with them. Fentanyl, a drug patch used for pain relief, has been specifically singled out by the FDA. In its July 2005 warning, the FDA urged exreme caution in prescribing this particular patch and it was never to be used to control...

• TV Drug Ads Face More Scrutiny

  Staff Writer | August 23, 2007 9:32 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  Pharmaceutical companies are required to present a balanced and accurate picture of a drug's benefits and risks. Yet, some critics argue that the visual pictures in television ads distort and overshadow warnings about the drugs. The issue has drawn the attention of federal regulators who plan to study the issue in the upcoming weeks. According to an announcement posted on the FDA website, the...

• Supplement Recalled for Making Cholesterol Claim

  Shannon Weidemann | August 22, 2007 3:04 PM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  A company that was touting a supplement as a way to lower cholesterol has recalled the product after the FDA stepped in. Sunburst Organics is recalling Cholestrix because it contains lovastatin. The recalled supplement contains red yeast rice with lovastatin and that can damage kidneys and muscles. The FDA informed Sunburst Organics that because Cholestrix made a cholesterol-fighting claim,...