Defective & Dangerous Products

• Guidant Papers Show Warnings Never Sent to Doctors

  Staff Writer | June 13, 2006 2:29 PM | 0 CommentsChicago, IL

  Newly released corporate documents show that, last year, Guidant drafted but never sent a detailed document to physicians which would have disclosed significant defects in its heart devices. Instead, executives of the company defended their failure to warn doctors by citing concerns that patients would have been at risk from unnecessary device replacement. The "Dear Doctor" letter was...

• Bone Drug Linked to Jaw Disease

  Staff Writer | June 02, 2006 2:25 PM | 0 CommentsChicago, IL

  A month after I blogged about Fosamax, the NY Times has run a front page story on the horrible dilemma facing patients with cancer or osteoporosis. The FDA has now required bisphosphonate labels to disclose the serious side effects of death of areas of bone in the jaw, which may occur in one of 10 patients who take the drug. Pharmaceutical companies are defending about 20 suits filed so far by...

• Tasers Safety Challenged Again

  Staff Writer | May 25, 2006 11:38 AM | 0 CommentsChicago, IL

  A professor of biomedical engineering at the University of Wisconsin has conducted a new study which showed that shocks from Tasers cause the hearts of healthy pigs to stop beating. This finding contradicts the previous research financed by, guess who, Taser International. The new study took into account that pigs have a thick layer of muscle insulating their hearts from their skin, so the...

• Merck Spins Vioxx Risks, Again

  Staff Writer | May 24, 2006 11:13 AM | 0 CommentsChicago, IL

  You can't believe everything you read, even in Medical Journals. Merck deliberately withheld information about three heart attacks from its data when the New England Journal of Medicine reported on VIoxx in March of 2000. Recently, Merck's spin machine is citing new data about patients who stopped using Vioxx after its recall to suggest that it reinforces Merck's argument that only patients...

• High Rate of Heart Device Recalls

  Staff Writer | May 22, 2006 11:51 AM | 0 CommentsChicago, IL

  A study based on FDA records for the last 10 years found that 164,000 external defibrillators (one out of every five) were subject to recall or agency alert. The data included 370 reports of deaths in which the defibrillator malfunctioned. Actually, the number was much higher, 801 adverse-event reports associated with death, but the study only counted the cases in which an emergency worker...

• Bausch & Lomb Disclosure Delays

  Staff Writer | May 19, 2006 12:07 PM | 0 CommentsChicago, IL

  Hey Bausch & Lomb, "what took you so long"? The first reports of the Fusarium fungus concerning ReNu with MoistureLoc arose from Hong Kong last November, but in its filing with the FDA on December 15, the company denied any problems with the product. Later, in February, Singapore reported a cluster of cases from the month before. Still later, on March 3rd, a New Jersey opthamologist complained...

• Heart Device Makers Feeling Heat

  Staff Writer | May 18, 2006 3:10 PM | 0 CommentsChicago, IL

  Several Medical Safety Groups have criticized the makers of heart devices, like defibrillators and pacemakers, for failing to alert doctors to life-threatening flaws in their products. The physicians believe the these companies don't fully assess the patient consequences because engineers, rather than doctors, made the decisions. Finally, two of the companies have agreed to broaden their...

• Bausch & Lomb Recalls ReNu with MoistureLoc

  Staff Writer | May 16, 2006 12:17 PM | 0 CommentsChicago, IL

  Citing safety concerns, Bausch & Lomb has permanenetly recalled its soft contact lens solution Renu with MoistureLoc. Scientists suspect the disinfectant, Alexidine, in combination with novel moisturizing agents, could have been absorbed into the lens and contributed to an outbreak of rare fungal infections which can scar the cornea and blind its victims. The company is NOT recalling its other...

• New FDA Warning About Paxil

  Staff Writer | May 15, 2006 2:39 PM | 0 CommentsChicago, IL

  After analyzing the data collected from about 15,000 patients, the FDA has written a letter to doctors and patients of newly discovered links between antidepressant PAXIL and an increased risk of suicides. The latest data revealed that 11 young patients (late teens to thirties) had attempted suicide after taking the drug. Paxilis one of the Serontin Reuptake Inhibitors or SSRIs, like Prozac...

• Beware of Off Label Prescriptions

  Staff Writer | May 11, 2006 10:14 AM | 0 CommentsChicago, IL

  Just because the FDA approves a drug for a specific purpose, that does NOT mean that the drug is safe or effective for other off-label uses. A recent study by the Stanford Prevention Research Center revealed that 15% of prescriptions were for off-label uses lacking scientific support, most commonly among heart drugs (excluding those for cholesterol and high blood pressure) and...