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Supplements can be dangerous to your health

Marketing drugs in the guise of supplements is illegal in the United States. Tainted Pai You Guo found where Chinese supplements are sold is just one small part of that global business. Federal authorities are struggling to identify and intercept these black-market goods, which, they warn, pose grave health risks.

The makers of legal dietary supplements — the kind found at GNC, for example — acknowledge they are reluctant to raise too many alarms. Even though there is little evidence that many dietary supplements provide real health benefits, legal supplements, from multivitamins to ginkgo biloba, are a big and growing business. Americans spent $28.1 billion on them last year, up from $21.3 billion five years ago, according to estimates from Nutrition Business Journal, a market research firm.

Many millions more are also being spent annually on black-market products, particularly those marketed for weight lossbodybuilding and sexual enhancement. Some of these products, according to the F.D.A., contain amphetamines, synthetic steroids, laxatives and compounds like the active drug in Viagra. Officials say such products can cause heart attacks and strokes, and can damage the kidneys and liver. A few people in the United States, they say, have died after taking them.

To read this entire NY Times article, CLICK HERE

Zocor is Dangerous

The Food and Drug Administration on Wednesday announced new safety restrictions on high-dose simvastatin, also known as Zocor, a cholesterol-lowering drug taken by an estimated 2.1 million Americans.

The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.

No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said.

This surely will lead to a spate of product/medical liability lawsuits against the manufacturers of this drug.

The drug’s manufacturer, Merck, advised patients on Wednesday to talk to their doctors if they wanted to change their statin drug or dosage. The company said many patients would not be affected by the F.D.A. action because they were taking lower dosages or had not felt muscle pain.

The F.D.A. approved 80-milligram Zocor in 1998, seven years after it approved lower dosages of the drug. It was once Merck’s top-selling product. Since the patent expired in 2006, simvastatin has mostly been sold as a generic drug.

The new restriction also applies to Vytorin, a combination drug sold by Merck and Schering-Plough that has some formulations in the 80-milligram dose.

And the restriction applies to Simcor, a combination pill sold by Abbott Laboratories. Simcor has lower levels of simvastatin, but may cause higher levels in the body interacting with other drugs, like blood pressure medicines amlodipine and diltiazem.

Two other statins are more potent and can accomplish the same cholesterol targets at lower doses, he said, citing Pfizer’s Lipitor and AstraZeneca’sCrestor.

Some doctors have prescribed simvastatin because it is cheaper in generic form. Lipitor goes off patent in November.

Muscle aches have long been known as a possible side effect of statins. The F.D.A. issued a safety warning on high-dose simvastatin in March 2010. On Wednesday, it said a seven-year study and patient reports prove that patients taking the higher dosage have a higher risk of muscle injury than those taking a lower dose of the drug or taking other statins.

The high doses accounted for 11.7 percent of 94 million simvastatin prescriptions in the United States last year and 15.5 percent of 8.6 million Vytorin prescriptions, the industry research firm IMS Health said.

Cancer-causing chemical found in baby products

More than 30 years after chemical flame retardants were removed from children’s pajamas because they were suspected of being carcinogens, new research into flame retardants shows that one of the chemicals is prevalent in baby’s products made with polyurethane foam, including nursing pillows, car seats and highchairs.

The research does not determine if children absorbed the chemical, chlorinated Tris, from the products. But in an article to be published Wednesday in the journal Environmental Science & Technology, the researchers suggest that infants who use the products have higher exposure to the chemical than the government recommends.

Earlier research by one of the article’s authors, Arlene Blum, a biophysical chemist, contributed to the elimination of Tris flame retardants, including chlorinated Tris, in children’s pajamas in the 1970s. Although the chemical was not banned at that time, the Consumer Product Safety Commission now says that it “may pose a significant health risk to consumers.”

The new research found that foam samples from more than a third of the 101 baby products that were tested contained chlorinated Tris. Over all, 80 of the products contained chemical flame retardants of some kind, some of which are considered toxic, though legal to use. In one instance, flame retardants represented 12 percent of the weight of the foam in a changing pad; most products were closer to 3 to 5 percent.

Read the full NY Times article:  Click Here

Artificial Colorings in Food and Behavior

Years ago artificial colorings were thought to be a cause of adverse health and behavioral effects in children.  Organizations such as Center for Science in the Public Interest and the Sidney Wolf's Health Research Group provided much evidence in support of this contention.  In the end, pediatric organizations determined that any connection was at best, tenuous.

Now, it appears that the issue is on the table again.  The FDA has taken up the cause and is leaning towards issuing formal warnings against artificial food colorings.  Why the change of heart?  A growing list of studies has affirmatively linked these food dyes to hyperactivity (ADHD and ADD) in children.

To see the full NY Times article:  Click Here

Addressing the worsening Methamphetamine problem

Several states are considering new legislation that will make decongestants prescription medication requiring a doctor's signature.  The main ingredient of these medications is pseudoephedrine, an essential ingredient in the production of Methamphetamine.  In one state alone, Tennessee, police shut down over 2000 Methamphetamine labs last year, about a 50% increase from the year before.

Methamphetamine is an extremely dangerous street drug.  Once an individual becomes habituated, studies show that their life expectancy is less than 10 years.  Once hooked, because of its effects on dopaminergic receptors of the brain, it is extremely difficult to stop use, and relapse is the rule rather than the exception.

To read the entire NY Times article:  Click Here

 

Diabetes Drug, Avandia, is Pulled Off the Market!

In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, will no longer be widely available.

The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart.

Read more by clicking here

Medical-Legal Nightmare: The FDA allows Opiates Free Reign!

An FDA panel has voted against the current version of the opioid risk evaluation and mitigation strategies (REMS) plan. Such a plan is critical to curb the misuse, abuse, and accidental overdoses related to these agents and to ensure opioids are used appropriately. However, experts feel the proposed approach does not go far enough to protect patients.  It is unclear if the FDA agrees with this.

 

Drug overdose death rates in the United States are at an all-time high. According to some reports, there are more deaths from oral opioid overdoses than from heroin and cocaine overdoses combined. In some states, these rates are higher than deaths from automobile accidents. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds.

 

This is clearly a risk management problem that needs urgent attention.  Over the past year I have seen a dramatic increase in medical malpractice and toxicology litigation in this area.

 

To read the entire report, please CLICK HERE.

FDA Advised to Block Avastin for Breast Cancer-Malpractice Cases May Result

A special advisory panel recently concluded that the drug Avastin, the world's best selling cancer drug, is useless for breast cancer.  This panel has now recommended that the Food and Drug Administration revoke its approval for this indication.  This expensive drug has been a go-to drug for breast cancer patients for the past few years. 

 

Unfortunately, studies now show that there has been no benefit, only false hope. This announcement may inevitably lead to an increase in product liability or medical malpractice lawsuits.  Attorneys practicing in this area of law should educate themselves according.

 

To read the full NY Times article, CLICK HERE.

Lead Poisoning: Still a Big Toxicology and Medical-Legal Issue

Lead poisoning among young children, which can cause learning and behavior problems, has decreased so sharply in recent decades that it is tempting to consider it a toxicology problem of the past. The Centers for Disease Control and Prevention was so confident about the decline in childhood lead poisoning that it set a goal of 2010 for eliminating it. Personal injury cases have decreased in recent years.

 

But federal health officials now say eradication may still be years away because hazards remain in often poor urban pockets — mostly from old, badly maintained housing with lead-based paint.

If the remaining cases are to be tackled effectively, local laws must be strengthened and enforcement increased, experts say.  To read the entire NY Times article:  Click Here.

Fish Oil Supplements Contaminated by PCBs

News for Product Liability Attorneys. Ten tested fish oil supplements were found to contain PCBs. Product liability attorney alerts- Tested fish oil supplements contained PCBs (Polychlorinated Biphenyls) which can cause cancer and birth defects; lawsuit filed today. Ten supplement companies sued, others not yet tested. Read the complete article: Click Here or for a second article: Click Here.
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