Zocor News

Based on new data, the FDA warned that higher doses of the cholesterol-lowering drug Zocor, sold generically as simvastatin, carry an increased risk of muscle injury.

The FDA also warns that mixing Zocor with certain other drugs also increases patients' risk of muscle injury, including the rare but serious complication known as rhabdomyolysis. Rhabdomyolysis can sometimes result in fatal kidney damage.

From the FDA site:

Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury


Patients should:

* Not stop taking simvastatin unless told to by their healthcare professional.
* Talk to their healthcare professional about any questions they have about the use of simvastatin.
* Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.


Rhabdomyolysis (often shortened to simply "rhabdo") is the rapid breakdown (lysis) of skeletal muscle (rhabdomyo) due to injury to muscle tissue. The muscle damage may be caused by physical (e.g., crush injury), chemical, or biological factors. The destruction of the muscle leads to the release of the breakdown products of damaged muscle cells into the bloodstream; some of these, such as myoglobin (a protein), are harmful to the kidney and may lead to acute kidney failure.

The damage is more common at the highest approved dose of Zocor, 80 mg. A large clinical trial comparing 6,031 patients taking 80 mg. daily with 6,033 patients taking 20 mg. found 52 cases of myopathy in the 80-mg. group and only one in the 20-mg. group. Eleven patients in the 80-mg. group developed rhabdomyolysis, but none in the low-dose group.

Betty Nestlehutt Video - Georgia Medical Malpractice Caps are Wrong

This is a video that discussed Atlanta Oculoplastic Surgery v. Nestlehutt, which challenges the provisions of Senate Bill 3, passed in 2005 by the Georgia General Assembly, that caps noneconomic damages that a jury may award to a victim of medical malpractice at $350,000.00.

The case arose from a medical malpractice claim filed by Adam Malone and Frank Ilardi on behalf of their clients Betty Nestlehutt and her husband Bruce Nestlehutt in the Fulton County State Court in October of 2008. Married for over 50 years, the Nestlehutts raised two children and they shared a real estate business. Bruce handled the behind-the-scenes work, and Betty, a people-person by nature, focused on client and public interaction. Competition was tough and as Betty aged she found that more and more clients seemed to prefer younger agents. So, at seventy-one years of age, Betty Nestlehutt, after much thought and consideration, sought consultation with Dr. Harvey P. Cole of Atlanta Oculoplastic Surgery, P.C. concerning bags under her eyes and lines around her mouth. Dr. Cole recommended she undergo several surgical procedures including a simultaneous CO2 laser resurfacing and full facelift.

Having both the CO2 laser resurfacing and full facelift done together is well-known by practicing cosmetic surgeons to be risky, as the chance of damaging the facial blood supply is greatly increased on a patient of Betty’s age and complexion. However, based on her doctor’s recommendation, Betty went through the combination of procedures and the blood supply to her face was, in fact, severely damaged.

After the surgery, the skin on Betty’s face struggled to live without its usual blood supply and after a 3-week period, died completely, leaving the once fair-skinned wife and mother with huge, gaping wounds from her temple to her jaw line, covering both sides of her face and over both of her cheeks to her chin. Betty Nestlehutt’s face, quite literally, fell off.

In the Nestlehutt case, a Fulton County, Georgia jury awarded Mrs. Nestlehutt well over $350,000.00 for permament injuries she received to her body due to medical malpractice by her physicians. After a trial, the Fulton County jury found Mrs. Nestlehutt's case to be meritorious and awarded her substantially more than the $350,000.00 cap. When judgment was about to be entered, however, the Fulton County trial court judge ruled that the cap of $350,000.00 found in SB3 was unconstitutional.

Expect a decision on this case soon.

Insulin Pump Dangers

Insulin Pump Dangers

The U.S. Food & Drug Administration (FDA) is working to reduce risks from dangerous problems that affect what it described as tens of thousands of diabetics. While the has not provided specific insulin pump manufacturers names in its report, there are known insulin pump makers, including Medtronic Inc, Roche Holding AG, and Johnson & Johnson, said Reuters.

Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.

The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.

Recalls:

MiniMed Insulin Pumps
The thin plastic tubes are used with the MiniMed Paradigm Medtronic insulin pump to deliver insulin to diabetes patients. The infusion set is typically replaced every three days. However, thousands of patients may have been sold infusion sets that may not allow the insulin pump to vent air pressure properly, potentially resulting in the device delivering too much or too little insulin.

Over or under delivery of insulin from an insulin pump could have serious and catastrophic consequences for diabetes patients.

Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with an “8”.

Accu-Check:

Accu-Check Spirit insulin pumps were previously recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. Malfunctioning buttons could prohibit users from changing any programmed setting on the Accu-Check Spirit insulin pumps. Another earlier recall was issued for battery caps included with some varieties of Aimas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.

Insulin Overdose Symptoms
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:

* Severe headache
* Increased/rapid heartbeat
* Nausea
* Tremors, anxiety
* Uncontrolled sweating
* Hypoglycemia

Hypoglycemia
One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Symptoms include: cold sweats, confusion, double vision, convulsions, fatigue and general discomfort. Severe hypoglycemia can result in seizures, coma and death.

Call us today if you believe that an improperly functioning insulin pump has harmed you. You may use the Contact Us form, or call Rob Bunch today.

Florida/Georgia: Denture Adhesives May Cause Zinc Poisoning and Neuropathy

Several Poligrip lawsuits have been prompted by cases of peripheral neuropathy in the United States among users of Poligrip and other denture adhesive creams. A serious neurological condition, peripheral neuropathy is most commonly seen among diabetics, and the Poligrip lawsuits contend that neuropathy is an unwarranted risk of a denture cream use that is not described by GlaxoSmithKline, the pharmaceutical giant that makes Poligrip.



Denture Adhesive Cream and Neuropathy

Millions of people in America have dentures and use Poligrip or another adhesive on a daily basis to keep their dentures in place. A link between neuropathy from denture cream was claimed to be revealed in the Poligrip lawsuits that have arisen in the past years. These lawsuits note the often debilitating symptoms of neuropathy:

* pain and/or tingling in the extremities (i.e., the "peripheral" part of "peripheral neuropathy")
* sensation disorders, such as a sensation of gloves or stockings being worn although the hands or legs are bare
* a loss of balance, difficulty walking
* cognitive decline

In some cases, neuropathy symptoms improve on their own after a period of time. Unfortunately, however, in other cases, treatment programs do not help and the neuropathy never goes away.
Poligrip and Zinc Poisoning

Neuropathy can be caused by:

* an injury
* a metabolic problem
* an infection
* exposure to toxins
* diabetes (about half of all diabetics develop some degree of neuropathy)
* alcoholism (because of poor dietary habits)

However, the link between denture creams such as Poligrip and neuropathy is based on the zinc content of the creams. Zinc — a mineral that is normally vital to one's health — is toxic at high doses. The USDA recommended daily allowance (RDA) for zinc is 15 milligrams of zinc from food and/or supplements every day. On the other hand, too much zinc can be quite harmful to one's health, because a high-enough level of zinc decreases the body's ability to absorb the essential minerals copper and iron.
In Japan on March 4, 2010, the Japanese subsidiary of GlaxoSmithKline (GSK), announced that it would begin a voluntary recall of Poligrip products that contain zinc in that country. The company's decision followed just three reports of adverse health effects in consumers of the product, sold in Japan as Poligrip EX.

Despite hundreds of American consumers reporting similar disabling effects stemming from the company's many zinc-containing products in the U.S., Glaxo's American subsidiary has yet to order a recall here.

In a letter in 2009, the company had “received an increased number of adverse event reports” that together with recent medical literature suggest that there were serious dangers associated with denture adhesives spiked with zinc.

Even as Glaxo warned doctors of the dangers posed by its denture cream, the company continued to blame users of its products, writing, “some patients apply more adhesive than directed and use it more than once per day.”

Talk with Mark Zamora, who may be reached at mark@markzamora.com or call 404-451-7781.