Injury Law Blog : Florida Injury Lawyer & Attorney : LaBovick Law Group : Serving West Palm, Boynton, North Palm, West Palm Beach, Jupiter

Do you believe in magic?  I don't. At least not one sided, free lunch, magic. I firmly believe that all things both physical and metaphysical have a cause and sometimes a worse effect. I think that sentiment holds true when discussing nutritional supplements. Everyone wants the free lunch. This supplement will make you thinner! That supplement will make you faster! The other supplement will make your xxx stand right up! Many times these supplements do not have their desired effect.

In the best of cases the supplement is simply lying. There is no actual cause and there is no actual effect. In other words the supplement is both harmless and also completely ineffective. But in the worst of cases the supplement actually has some cause. I say the worst of cases because typically, and I have not found this to be incorrect, the cause is nowhere near as bad as the effect.  What I am talking about are those supplements that increase your strength, speed, agility and ability to push your body to its maximum level. Clearly they are effective. They raise your metabolism, they raise your blood pressure, and they change your body chemistry. Yet, there are consequences. Many people who take these supplements have significant and serious side effects.

The New York Times reported that a GNC product called "Jack3d" (you simply say Jacked) was the alleged cause of two US Soldiers deaths.  This claim has been outstanding for some time, and US Military and the Department of Defense have taken the product off its shelves. Meanwhile GNC is running a "special" on its website for this workout supplement.  Jack3d is a powder you mix with water.  The stimulants and vitamins in Jack3d increase "strength, speed and endurance."  The active stimulant in Jack3d is called dimethylamylamine, or DMAA.  The FDA warns that DMAA can raise your blood pressure and heart rate to the level it can cause a heart attack.

It's not unusual for an out of shape 50 year old ex-athlete to start a workout program, want quick results, and use an unduly strong stimulant, and keel over with a heart attack.  We all just feel bad for the guy and think he over did it without first getting a physical. Although, that's not what is happening with some of the strongest supplements. Now we are faced with the deaths of two soldiers who used Jack3d. “Now the parents of Michael L. Sparling, one of the soldiers who died, have filed a wrongful-death lawsuit against USPlabs, the developer and marketer of Jack3d, and GNC, the store where he bought it.” reports the Times.

I bet there is a real split in public opinion on this topic.  We don't regulate natural supplements. We don't, as a government, protect our citizens from products that can be dangerous. Heck, cars are more dangerous than a nutritional supplement, so how far should the government go?  My suggestion is to buy out.

The lawsuit was filed in early February in San Diego. The claim centers on deceptive marketing. Is it ok to market Jack3d as "safe and effective" without a warning on potential side effects?  If so, let a jury decide. Sounds like a winner of a case, but before I pass judgment I want to hear the facts!  

Meanwhile I'll stick with my plan:  eat healthy, work out consistently, and don't believe in magic pills to make me taller and give me a full head of hair!

 

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Some experts are now saying that the active chemical used in spray tans, dihydroxyacetone (DHA), could potentially cause serious health issues. Originally approved by the FDA back in 1977 for “external” use, DHA was previously used as a topical lotion that became unpopular due to its blotchy orange appearance. In recent times, spray applications that utilize DHA have enabled the chemical to maintain a more even and all-over appearance. This has created resurgence in the chemical’s popularity. The problem then arises due to the new mist-like application of spray tans and DHA.

The FDA never expected the chemical to be applied with an all-over spray method in the 1970s and have now stated that “DHA should not be inhaled or ingested.”

Since individuals are unaware of the potential health risks of consuming or inhaling DHA, people undergo spray sessions in small confined booths, all while being completely immersed in the chemical. Most tanning salons also do not properly educate their patrons before sessions, so individuals receive their tans without protecting their eyes, nose and mouth from the harmful fumes.

The FDA now tells consumers on its website that "the use of DHA in 'tanning' booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the agency for review and evaluation."

The major concern comes when DHA is inhaled into the lungs and the chemical goes into the bloodstream. While much speculation leads experts to fear for potential cancer, tumor or DNA risks as a result of DHA exposure, the main reason to worry is simply that the chemical has not been adequately tested for what it is currently being used for. It is therefore very important to understand that spray tans are not necessarily a harmless alternative to UV rays, and you are potentially at great risk when you undergo a spray treatment that utilizes DHA.  

Click here for the Good Morning America  report the dangers of spray tanning and how to protect yourself

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Bad Drugs need to taken off the shelf: Acutane, Yaz, Yasmin, Ocella

It is incredible that young women are still taking Yaz or Yasmin or Ocella. All we hear about these drugs are bad, bad, bad. Given all of the issues, I do not understand why they are still on the market. The power of the drug industry amazes me, that despite all of the serious and life altering side effects which can occur while taking the Yaz trio, doctors are still prescribing these drugs and young women still take them.

We have cases from all over the country. There are no geographical boundaries to taking a drug tort case. Most of our cases are either blood clot/DVT (deep vein thrombosis)/PE (pulmonary embolism), Heart Attack or Stroke.

How in the world other than taking a poison like the Yaz trio could a young woman have a heart attack or stroke? We have not had many death cases due to these injuries because the victims are young and strong. But this only means that, in the long run, these young woman will suffer with the effects of their injury for the rest of their lives. We have interviewed hundreds of prospective clients and it is amazing how many have claims. Between the Yaz trio and Accutane I don’t know which is a worse scourge in the young adult community.

Just for the record, Accutane is every bit as bad as the Yaz trio. The injuries and long term affects of this anti acne drug so far outweigh the relative health benefit that it also amazes me that Doctors can, in good faith, prescribe this drug to their patients. So many of the people we interview simply should never have qualified for taking this drug. It cannot be a causal solution to acne.

The number of young people who have developed bowel trouble after taking Accutane is incredibly high. The bowel trouble comes in many forms, Crohn's Disease, Ulcerative Colitis or Inflammatory Bowel Disease. Some of the lesser known side effects of using Accutane include pancreatitis and hypertension, hair loss and hepatitis.

If you are taking either Yaz or Accutane please go back to your doctor and ask for an alternative treatment for either birth control or acne. You will never die from bad acne and you can control getting pregnant in other formats beyond these drugs. Your life is literally at risk.
 

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DePuy Orthopaedics Inc., a division of Johnson and Johnson is voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

These type of "metal-on-metal" hip implants can cause particles to go into a patient leading to harmful, painful reactions, and frequently lead to further surgeries.

The following statement was released by Depuy to the public:

"Data recently received by the company shows that more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery. For this reason, DePuy Orthopaedics is voluntarily recalling its ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and treatment may be necessary to ensure the hip is functioning well. In some cases, patients may need additional surgery."

Click on the following links to read more on the Depuy Orthopaedics Hip Replacement Recall

Medical News Today: Hip Replacement Recall By Depuy Orthopaedics Is Big News

Depuy Recall: (A J&J Division) DePuy Orthopaedics Voluntarily Recalls ASR™ Hip System

FDA Warning Letter to Depuy Orthopaedics 8/19/10

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Reglan (metoclopramide), a prescription medication used to treat gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) in children and adults has been linked with Tardive Dyskinesia, a potentially permanent movement disorder.

The FDA approved Reglan for short term use in 1995.  However, approximately, one-third of patients taking Reglan including the generic form, metoclopramide, are on the drug for 12 months or longer. In 27 to 29 percent of the patients, there is a prevalence of Tardive Dyskinesia. 

Tardive Dyskinesia is a neurological disorder that consists of potentially irreversible, involuntary movements of the face, lips, mouth, tongue, and sometimes the legs, arms, and trunk. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of Reglan use and the total cumulative dose..

On February 26, 2009, the U.S. Food and Drug Administration (FDA) announced that manufacturers of metoclopramide must add a black box warning to their drug labels to warn about the risks associated with its long-term or high-dose use.

Tardive Dyskinesia is characterized by repetitive, involuntary movements. These symptoms range from being very mild to very severe, which may be irreversible. Some of these symptoms include:

Jerking movements of the tongue,face, mouth, and jaw Involuntary movement of the hands and fingers Uncontrolled movement of the arms, legs, and trunk. 
 

If you or a loved one has developed Tardive Dyskinesia as a result of taking Reglan, see your doctor immediately for an evaluation.

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide/ Reglan

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McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc. (McNeil) issued a voluntary recall of some of its most popular children’s medicines on Friday, including multiple varieties of the popular Children’s Tylenol and Children’s Motrin. The Johnson & Johnson unit issued the voluntary recall in consultation with the U.S. Food and Drug Administration (FDA) due to “manufacturing deficiencies” and because the products “may not meet required quality standards.” The FDA is urging consumers to stop using the affected products immediately.

According to the FDA, the manufacturing deficiencies have the potential to affect the purity, quality and even potency of the recalled over-the-counter children’s medicines. The New York Times reports that certain lots of the products may contain a larger amount of the active drug ingredient than specified, and that other recalled products could contain ingredients or foreign particles that may not meet McNeil’s testing requirements.

The recall involves more than 40 different sizes and flavors of seven well-known products, including:

•    TYLENOL® INFANTS’ DROPS
•    CHILDREN’S TYLENOL® SUSPENSIONS
•    MOTRIN® INFANTS’ DROPS
•    CHILDREN’S MOTRIN® SUSPENSIONS
•    CHILDREN’S ZYRTEC®  LIQUIDS IN BOTTLES
•    CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

McNeil’s voluntary recall comes in response to a routine inspection of the company’s Fort Washington, P.a. facility on Friday in which federal health inspectors found multiple manufacturing violations. According to the New York Times, this is McNeil’s second major recall of 2010, the other taking place in January involving over-the-counter adult and children’s medicines manufactured at a plant in Puerto Rico.

Children’s Tylenol and Other Drugs Recalled – New York Times

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products – McNeil Press Release (includes list of recalled products)

FDA News Release about Recall

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 The U.S. Food and Drug Administration has issued a warning to patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

Zocor, manufactured by Merck & Co, is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Abbott Laboratories Simcor. Simvastatin also is available as a single-ingredient generic medication.

Myopathy, a muscle injury, is a commonly known side effect with all statins. However, the recent FDA warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug.

Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP) stated the following:

“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available. It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”

Merck stock closed at $38.06.

Click on the following links  to read more on the FDA warning on Zocor and potential increased risk of muscle injury.

FDA issues warning for high doses of Zocor - Reuters
FDA warning on cholesterol drug Zocor - ABC News
Merck falls on Zocor warning - Investors.com

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