January 27, 2012

Knee and Hip Implants: New Not Always Better Than Old?

New technology is supposed to be better than the old, but what happens if the new proves not only to be more expensive, but can show no real advancement prior to the older versions? Technology is an advancing arena but, with artificial hip and knee replacements, it is proving to not be the case.

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January 12, 2012

Possibility of Smith & Nephew Journey Knee Fracture

The ability to move around without pain is something most of us don’t think about, so when patients undergo knee replacement surgery they believe their pain will go away. However, if the patients are still experience pain it could be the result of a fracture, if the replacement was a Smith and Nephew-Journey knee.

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January 11, 2012

Ortho Evra Patch – Is it Worth the Risk?

The Ortho Evra Patch provides women with a simple solution for their birth control needs. A patch applied to the skin once a month is more convenient than a pill taken every day. As with most medicines today, there are always side effects to go along with the benefits of taking a certain drug. But at what point do the risks start to outweigh the benefits and conveniences of taking it? Most hormone based contraceptives increase your risk for developing blood clots, but the risk is three times greater with the Ortho Evra Patch. This increased risk comes from higher levels of estrogen as well as the constant dosage of estrogen found in the Ortho Evra Patch but not the pill.

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January 10, 2012

FDA ORDERS MORE TRIALS FOR VAGINAL MESH PRODUCTS

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are not easy subjects for women to talk about. SUI and POP are often the outcomes of weakening muscle tension caused by age or child birth. Stress urinary incontinence is triggered by the weakening of the pelvic muscles, and it can lead an involuntary loss of urine that results from physical activity. Pelvic Organ Prolapse is a condition where a pelvic organ drops and the bulges against the walls of the vagina often protruding outside the vagina.

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January 4, 2012

Appellate Court Reinstates Hormone Therapy Verdicts for Punitive Damages

Yet another appellate court has condemned drug-maker Wyeth Pharmaceuticals for its conduct in failing to study and failing to warn about the breast cancer risk associated with its hormone therapy drugs.

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December 1, 2011

The Dangers of Proton Pump Inhibitors - It is time for a Black Box Warning

Proton Pump Inhibitor Drugs (PPIs) like Nexium and Prilosec are among the most popular drugs in the world but perhaps they may be the most dangerous when taken over the long-term. I have written about the risks of this class of drugs multiple times in prior blogs (see blogs regarding dependency, bone fractures, infections, among others) but I believe it is necessary at this point to support Public Citizen's petition with the FDA to finally put a Black Box warning on these drugs. see www.citizen.org/petition-asking-fda-to-add-warnings-to ppis.

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November 30, 2011

Ironically – the Osteoporosis drug Fosamax causes Femur Fractures

Doctors have been prescribing Fosamax for years to prevent bone loss. And last year, for the first time, the FDA required manufacturers of bisphosphonates, including Fosamax, to warn about the fact these drugs can cause a serious bone fracture. Ironically, the drug causes the very indication that the drug was supposed to prevent. This isn’t the first time we’ve seen drugs cause the very problems that they were prescribed to protect against. We had seen this before with antidepressant drugs that were supposed to prevent suicide but actually caused it.
The FDA’s action was apparently prompted by a study of more than 300 women who had suffered leg fractures while taking these drugs. And earlier this year, the FDA mandated that manufacturers of bisphosphonates include language in their labels stating that the optimal duration for patient use has not yet been determined.

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August 23, 2011

More Warnings for Levaquin - May exacerbate muscle weakness in patients with Myasthenia Gravis

Last December, Ortho McNeil-Janssen Pharmacetuicals added new labeling to its blockbuster antibiotic Levaquin. This updated black box warning, states that "Fluoroquinolones, including Levaquin, may exacerbate muscle weakness in persons with myasthenia gravis," a neuromuscular disorder. Levaquin and other fluoroquinolones have neuromuscular blocking activity and have been linked to serious adverse events in patients with myasthenia gravis, including ventilatory support and deaths. This warning is in addition to the July 2008 Black Box warning concerning the increased risk of tendonitis and tendon rupture.

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July 26, 2011

FDA ISSUES SECOND WARNING ABOUT COMPLICATIONS ASSOCIATED WITH TRANSVAGINAL MESH DEVICES

As women age, they sometimes suffer from a condition called pelvic organ prolapse ("POP"). Some doctors have treated this condition with a medical device called a surgical mesh. These surgical mesh devices - made from the same material as Rubbermaid storage containers - have never been tested on patients. Unfortunately, these untested devices have been found to erode patients' insides, which can result in constant pain and additional operations.

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June 29, 2011

Paid Researchers Covered Up Serious Risks of Medtronic Infuse Bone Grafts

In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn't report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.

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June 3, 2011

FDA Warns Not to Use SimplyThick in Milk/Formula with Premature Babies

The FDA recently announced in late May that 15 infants who had been given the product SimplyThick developed a life-threatening intestinal condition known as necrotizing enterocolitis (NEC), and that two have died. This has led the FDA to warn all parents, caregivers, and health care providers NOT to use SimplyThick to help with swallowing problems in babies who were born prematurely. Nearly all of the 15 infants who developed the condition had been born prematurely (before 37 weeks) but had been released by the hospital with a diet regimen that included SimplyThick to be mixed with their milk or formula in order to thicken it so that the babies would be able to keep their liquids down.

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May 3, 2011

Fraudulent Over-the-Counter STD Drugs

The FDA has an announced a joint initiative with the Federal Trade Commission (FTC) to combat fraudulent over-the-counter products that claim to be treatments for sexually-transmitted diseases.

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