Pharma Watchdog

Do any of your OTC meds contain caffeine

Do any of your OTC meds contain caffeine

Do any of your OTC meds contain caffeine? You MUST read this! http://ow.ly/olizp

FDA Says Metal-on-Metal Hip Implants Cause Soft Tissue Damage

Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of the device are both made from metal.

Metal-on-metal total hip replacements were introduced for their supposed advantages over conventional devices, such as low rates of wear and increased stability. However, concerns about all-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip devices, after it was found that they were failing in about 12 percent of patients within just five years of implantation.

The U.S. Food & Drug Administration (FDA) began studying all-metal hip implants shortly after the DePuy ASR hip implant recall to determine if the devices are shedding dangerous levels of metal ions into patients’ surrounding tissue and blood streams.

Now, in latest news, according to a new report made public by the US Food and Drug Administration (FDA), all-metal hip implants need be linked to both soft tissue damage and pain.

Because of this, it is likely that an individual who was fitted with a metal-on-mental hip implant will at one point require additional surgeries in order to have their implant removed and replaced with a new one.

Despite the fact that all-metal hip implants are supposedly sturdier than other options patients have at their disposal, it looks like the disadvantages might sometimes outweigh the benefits.

Thus, the FDA claims that these implants can lose metal at points where two components connect. This translates into the implant itself becoming prone to failure, and into bone and soft tissue damage.

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DePuy Metal-on-Metal Hip Replacement Lawsuits Heating Up

Thousands of lawsuits are alleging the ASR hip implant’s defective design is prone to early failure, risk of serious injuries, and likely to require revision and replacement surgeries to correct the problems it causes.

Most of those lawsuits have been consolidated in the litigation now underway in the U.S. District Court for the Northern District of Ohio.  The federal court is the setting for a growing Multidistrict Litigation against DePuy and Johnson & Johnson (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation).

Metal-on-Metal Hip Implants Cause Tissue Damage and Toxic Levels of Metal

Numerous post-market studies have shown these implants are prone to early failure in as many as 13 percent of the people who received them. Some studies suggest the early failure rate could be higher. Despite this, the road to an eventual replacement surgery is painful and marked with visits to the doctor and revision surgeries to correct early problems caused by the DePuy ASR hip.

Recipients of the device have reported hearing popping and creaking at the site of the implant. These noises are often accompanied by pain and inflammation. In some cases, the device has completely failed unexpectedly, requiring immediate surgery. More serious however, is the overall concept of the ASR hip implant and others which rely on a metal-on-metal design. Through normal wear-and-tear of the hip implant, small metal particles are likely to be shaved off the joint surfaces and dispersed into the bloodstream and nearby tissues and muscles.

Toxic Cobalt and Chromium

Many recipients have recently found they are suffering from toxic build-up of the metals cobalt and chromium, a condition that can cause muscle damage, death of surrounding tissues, accumulations of the metal in the body, organ damage, and eventual organ failure.

Visit Sadaka Associates LLC for more information on metal-on-metal tissue damage 

Bayer Seeing Fallout From Yasmin In Switzerland & France

Bayer continues to get backed up against the wall as more allegations arise against the controversial contraception Yasmin.

The latest news comes from the Swiss where according to Reuters, Switzerland’s biggest health insurer CSS is supporting a young woman in her claim against Bayer, as the fall-out from alleged side effects of the German drugmaker’s contraceptive pill widens.

CSS said it supported its client in her claim against Bayer and is acting as a joint plaintiff. The health insurer is demanding payment from Bayer to cover medical costs.

Swiss media reported the young woman suffered from a pulmonary embolism, a blood clot in her lung, that left her severely disabled a few weeks after being prescribed the pill. The cost of medical treatment has amounted to some 600,000 Swiss francs ($648,600), according to reports.

A Bayer spokesman said the company could not comment on pending lawsuits but added the Yasmin group of pills had a positive risk-benefit profile based on extensive scientific data.  He also said the decision which contraceptive to take rests with the patient and her doctor.

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Journal Refuses To Retract Controversial Paxil Study

The Journal of the American Academy of Child and Adolescent Psychiatry says they refuse to retract a study known as Study 329, even though following a lawsuit with GlaxoSmithKline the controversial study involving Paxil was proven to be misleading and distorted.

One global nonprofit Healthy Skepticism expressed concern that the study, which identified the drug Paxil as an effective combatant of depression in children, “seriously misrepresented both the effectiveness and the safety” of the drug. They say that the study’s continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.

Last summer, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. One infraction, in particular, concerned this controversial study, further leading some to believe that it is without question that the study be retracted.

The feds claimed the GSK participated in preparing, publishing and distributing what was called a “misleading medical journal article” because the results misreported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study failed to demonstrate efficacy.

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