Archive for March 2012

Honda Recalls 554,000 SUVs Over Headlight Issues

March 31, 2012

2002 Honda CR-V

(March 31, 2012) Honda announced that over 550,000 CR-V’s and Pilot’s will be recalled due to failing low-beam headlights.

 

In 2011, Honda recalled more vehicles than any other U.S. auto manufacturer, and it seems as though 2012 will be no different. Only three months into the new year, this recall comes as the latest of over a half-dozen safety-related actions Honda has been forced to make.

 

There reportedly isn’t enough slack in the wiring, and routine vehicle use can lead to the wire snapping, in the 2002-2004 models of the CR-V, as well as the 2003 model Pilot. No crashes or injuries have been reported as a result of this defect, and this defect only affects the low-level beams.

 

Owners will get recall notices via the mail in early April, and Honda is also asking owners to stop by their local dealers so they can inspect the vehicles, and replace the wiring, if necessary.

 

Owners may also visit http://www.recalls.honda.com , or may call (800) 999-1009 and select option 4.

 

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FDA–Approving Medical Devices Before Testing for Safety

March 29, 2012

(March 29, 2012) Approximately 17 percent of American adults have an implanted medical device, according to a recent survey by the Consumer Reports National Research Center. While millions of Americans live with medical devices implanted in their bodies, the report says that many of these implants have never even been tested for safety. In fact, according to Consumer Reports, manufacturers often are required to do nothing more than file paperwork and pay a “user fee” before bringing their products to the market.

 

Consumer Reports gave examples of several devices that it says have had significant problems through the years, yet they were not subject to extensive testing before going on the market. In particular, the story discussed the FDA’s 510(k) approval process. Under this process (which is similar to the way generic drugs are approved), medical device makers can get clearance to market a device that is “substantially equivalent” in safety and effectiveness to another approved device when it is used for the same intended purpose.  According to Consumer Reports, the problem is that the companies exploit a loophole in the law that allows them to submit new products to the FDA for instant review, as long as they classify them as an upgrade, even if the product has changes that can affect safety.

 

The Consumers Union, which is the advocacy arm of Consumer Reports, recommends that Congress make the FDA require that implants and other “life-sustaining” devices be tested as rigorously as drugs.

 

When a doctor implants an experimental device, that patient is required to undergo surgery. Once the device is found to be faulty, another surgery is required to remove it, adding to the risks.

 

We have reported about many of these medical devices that have caused pain, harm, and even death to countless patients, due to the current “approval” process in this country.  Numerous and repeated complications of trans-vaginal surgical mesh implants used to correct pelvic organ prolapse, which have been marketed without human testing. As we reported earlier, many of the implants were approved based on a mesh product from Boston Scientific, which was recalled in 1999.

 

Another device we have previously reported to you are the metal-on-metal hip replacements. There is an increased failure rate in certain models, however, they were approved before proper testing was obtained.

 

U.S. regulators approved the Lap-Band weight loss device with little or no advance safety testing, as reported in Consumer Reports magazine Wednesday. It says that the FDA’s approval of the device was based on a clinical study of only 299 patients. Of those, 25 percent had their Lab-Bands removed before the end of the 3-year study, due to complications or failure to lose enough weight. Allergan Inc. has sold more than 650,000 Lap-Bands worldwide. A year ago, the FDA approved the Lap-Band for use in patients that are less obese. The FDA’s approval was based on a study that showed 80 percent of patients who used the device had lost at least 30 percent of their excess weight and kept it off for one year. Does that make it “safe?”

 

Advocates for industry reform in Washington say it is difficult for lawmakers to muster enough votes to ensure the passage of a bill to grant the FDA authority to reject a 510(k) device application.

 

Some people have come forward in other ways. A few months ago, we reported to you that in January, FDA whistle-blowers leaked information to congressional staffers in 2009 that warned of a potentially unsafe cancer-screening device, which was receiving government approval. Those former employees have filed suit against the FDA, alleging that their supervisors spied on their work computers, using that information to harass and fire them.

 

Patients need to do research on their own before having medical devices implanted in their bodies. It is unfortunate that we cannot count on the FDA regarding the safety of medical devices today. It takes years after a device is on the market to find out if there are problems or recalls with that device. It is better to be safe than sorry.

 

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Toxic Gases Are the Silent Killers

March 28, 2012

(March 28, 2012)  Toxic gases can kill or injure people, both slowly and instantaneously, at home and in the workplace. These silent, harmful gases are produced naturally and intentionally. The three most common toxic gases are:  hydrogen sulfide, carbon monoxide, and methane.  They can subject innocent, unsuspecting people to harm or death in their homes or in the workplace. If safety procedures and safety devices are in place, many lives can be saved.

 

Hydrogen sulfide is known as “sewer gas” or “stink damp” for its rotten egg smell.  It is colorless and flammable and extremely hazardous. It can cause death in high concentrations in just a few breaths. It occurs naturally in crude petroleum, natural gas, volcanic gases, and hot springs, and also results from bacterial breakdown of organic matter.

 

Carbon monoxide (CO) is an odorless, colorless, lethal gas that is impossible to see and taste. In low concentrations, it causes flu-like symptoms:  headaches, dizziness, nausea, and fatigue. At high concentrations, it is a silent killer. It is generated by gasoline-powered equipment, such as motor vehicles, electric heaters, generators, gas stoves, and leaking chimneys. Tobacco smoke also generates carbon monoxide.

 

Methane is a colorless, odorless gas. In commercial natural gas production, they add sulfide to give the gas a detectable smell. Although methane is not toxic when inhaled, it can cause death by suffocation, as it prevents oxygen intake in the body. The principal use of methane is fuel, and an undetected gas leak could result in an explosion or asphyxiation.

 

To prevent danger from toxic gas in the home, carbon monoxide detectors should be installed and properly maintained with working batteries. In the workplace, employees should be informed and provided with updated safety equipment. In industries where toxic gas is known to exist, OSHA requires safety procedures, training and safety equipment.

 

Today, there are many detectors available that monitor the amount of gas in the air. For home use, they have monitors that signal an alarm to alert the family while they sleep. In the workplace, safety systems should always be installed. Each year, nearly 5,000 people in the United States are treated in hospital emergency rooms for carbon monoxide poisoning; however, this number is believed to be an under-estimate, because many people with carbon monoxide symptoms mistake their symptoms for the flu, or are misdiagnosed.

 

They have even come out with a smartphone that is capable of sensing high levels of toxic gas, sounding an alarm and sending an alert to the fire department.  With all the detectors and devices available today, no one should suffer from these silent killers anymore. Hopefully, all workplaces will have these detectors in working order, especially in confined spaces.

 

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Settlement in BTSI Manufacturer’s Defect Case

March 27, 2012

(March 27, 2012) There are many reasons you should never leave young children, toddlers, or infants in the car alone.  The most obvious reasons are that they can be kidnapped, they can suffocate if the car is not running, they can choke on something, and many other strange things can occur.  The accident that occurred when these two toddlers were left alone in the car is so horrific and could have been prevented.

 

A woman drove her SUV to make a payment at her insurance company’s office. All the paperwork was ready, awaiting her payment at the front desk. She parked by the front door, leaving her 6-month-old baby and her 2-year-old niece buckled in their car seats while she dropped off her payment. When she walked back outside to her SUV, she found her 2-year-old niece standing in the driver’s seat. When the little girl turned to go to the back seat, suddenly the SUV leaped forward, pinning the woman against the insurance company’s building. Due to the crushing injuries, her left leg required amputation above the knee, and her right leg developed lymphedema (a chronic, serious swelling).

 

An engineering expert discovered that the SUV was equipped with a safety device known as a brake transmission shift interlock (BTSI). The purpose of the BTSI is to prevent the gear shift lever from being moved out of park into gear, without the driver having to step on the brake pedal.

 

Unfortunately, it was discovered that the BTSI in the victim’s SUV suffered from a design defect that sometimes prevented it from operating properly.  On occasion, when the operator shifted the SUV into park, the BTSI failed to lock the shift lever in park. This resulted in the gear shift lever being moved from park into gear, without requiring that the operator step on the brake first.

 

On the day of this tragic accident, the defective BTSI allowed the victim’s niece to inadvertently move the shift lever into a forward gear.  This is obviously a very dangerous defect for which safer alternative designs should have prevented this from ever taking place.

 

The case was settled on the eve of the trial, the amount of which is confidential. 

 

In 2006 the National Highway Traffic Safety Administration (NHTSA) asked automakers to add BTSI systems to all new models in the U.S. with automatic transmissions. No matter what position the key is in, the driver must have a foot on the brake when shifting the car out of park, which would have prevented this accident. BTSI systems have since been included in approximately 80% of cars made since 2006.

 

It is such a travesty that the victim’s BTSI was defective. The very purpose of having the BTSI installed in automobiles is to prevent exactly what happened here. In this case, it proved defective, causing permanent impairment to this young mother. Is this justice?

 

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Judge Orders FDA to Begin Limiting Two Antibiotics on Farms

March 27, 2012

(March 26, 2012)  A federal court judge has ordered the U.S. Food and Drug Administration to restart the 35-year-old process to stop farmers from using two types of antibiotics in healthy animals. Scientists have warned that this practice is contributing to the growth of antibiotic-resistant bacteria, which could infect humans.

 

The FDA approved antibiotic use in animals in 1951, before any concerns regarding drug resistance were recognized.

 

In a ruling handed down on Thursday, the judge ordered that the FDA must begin taking steps to withdraw approval of the two antibiotics for routine use in animals, siding with four consumer safety groups that brought a lawsuit against the FDA last year.  Even though the FDA first indicated that it would start limiting the non-medical use of antibiotics in 1977, they have failed to take corrective action against the livestock industry. This is what prompted the lawsuit by the watchdog groups.

 

In 1977, the FDA found that the overuse of antibiotics in livestock (cattle, pigs, and poultry) weakened the treatment’s effectiveness in humans. The FDA issued an order, which would have banned the non-medical use of penicillin and tetracycline in farm animals, unless the drug makers could prove that the drugs were safe. Unfortunately, this rule was never enforced, due to the tenacious pushback from Congress and lobbyists for farmers and drug makers. The farmers argued that these drugs are given in low doses and are necessary to keep animals healthy and to promote growth.

 

However, the use of antibiotics for non-therapeutic reasons has long been known to be unsafe for humans, because it builds antibiotic-resistant bacteria, known as “superbugs.” The same is true for the farm animals. After constant use, some animals develop germs that are immune to antibiotics. These germs (or superbugs) can then pass to farmers and their families, and even the consumers.

 

Public health advocates have been pushing the federal government to put more restrictions on antibiotics for decades. Nearly 80 percent of all antibiotics sold in the U.S. are given to farm animals used in food production, according to a recent estimate by the FDA. The farmers mostly use the drugs in healthy animals to aid in their growth and prevent them from illness in crowded, unsanitary feedlot areas. Critics say that the levels given to the animals are too low to actually treat diseases.

 

Earlier this year, the FDA banned non-medical use of the antibiotics classified as “cephalosporins,” which are sold for human use under brands such as Keflex, Ceftin, and Cedax, used to treat bone, urinary tract, and respiratory infections. Cephalosporins (unlike penicillin and tetracyclines), were never approved by the FDA for non-medical use in animals.

 

Beginning April 5, 2012, it will become illegal to use the antibiotics in healthy animals as a way to help prevent disease. Use of the antibiotics to treat specific illness in farm animals will remain legal.

 

The problem with the over use of antibiotics in farm animals is that it not only affects the meat from cattle, pigs, and poultry, but the dairy products, as well.  The superbug known as MRSA (methicillin-resistant Staphylococcus aureus bacteria) has increased over the years. It is said that MRSA infections have accounted for over 60 percent of hospital staph infections. The CDC reports that about 126,000 hospital MRSA infections occur annually, resulting in up to 20,000 deaths, because MRSA infections are resistant to antibiotics.

 

If the FDA does not crack down on the farmers to stop the over use of antibiotics, the American public is at great risk.  These efforts began 35 years ago and still are not resolved. If the FDA knows that these practices are unsafe for humans due to the risk of promoting antibiotic resistant bacteria, why is this still taking place in 2012?

 

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1.6 Million Cases of Bottled Water Recalled

March 24, 2012


(March 24, 2012) The U.S. Food and Drug Administration (FDA) announced this month in the Enforcement Report that two companies recalled large numbers of bottled drinking water. It was thought that bits of plastic were possibly found inside the bottles.

Safeway recalled 1.6 million cases of Refresh Purified Drinking Water in California, Nevada, and Hawaii.  Safeway alerted the FDA about the plastic fragments (some as large as 12 mm in length), on February 9, 2012. The recall is ongoing.

Additionally, 39,000 cases of bottled water were recalled nationwide and in Canada by AquaHydrate last December. It is not clear whether any of the water bottles reached the consumer level, however, this is the first time the FDA has participated in announcing either of these recalls. This recall is ongoing, as well.

It is ironic that the slogan used by Safeway is “enhanced with minerals for fresh taste!”  Not sure if the plastic fragments are tasty, but they sure can pose a danger!

Safeway 24-pack 500 ml bottles per case have UPC # 00 021130 24032. The “best by” dates are beginning with 8-26-13 up to and including 1-19-14. The 6-pack bottles have UPC #00 21130 24043. The “best by” dates of 9-23-13, 11-17-13.  The 500 ml/16.9 fl. oz. plastic bottle has UPC # 00 21130 24030. The “best by” dates 8-26-13 up to and including 1-19-14. They all have the same designation # of S 8245.

Since the year 2000, spending on bottled water in the United States has more than doubled to almost 12 billion dollars per year, which leads the world in sales, although the French company, Perrier, is generally viewed as the originator of the category (of bottled water) in the 1970’s.

Not only do we have to worry that the bottled water we spend money on, actually is clean, filtered water, as opposed to straight from the tap, we now have to worry that we will get more than just water in the bottle! Glad to see that the FDA is doing its job in protecting the public by announcing these recalls. Even though this is the first time the FDA has joined the companies in the recalls, hopefully, they will continue putting the public’s safety first.

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Generic Keppra (Anti-epileptic drug)

March 24, 2012

(March 26, 2012)  It seems that generic medications have been having their share of problems lately. Just this week we reported that lawsuits could not be filed if a generic was used. The average patient does not know this, nor does the pharmacists make us aware of this. Generics are developed to save patients money, while providing the same qualities as name brands would, and not to increase the problems of the disease or illness.

 

The generic version of the anti-convulsive medication Keppra, commonly used to treat patients that suffer from seizures, such as epilepsy or other seizure disorders, is known as Levetiracetam. Keppra or Levetiracetam may be administered to patients who have had a traumatic brain injury (TBI) and had seizures from their brain injury. Generic Keppra is made by a number of different manufacturers.

 

Keppra, the brand name seizure medication, was approved in 2009. Soon after, patients were switched to the generic, Levetiracetam. It is thought that if these generics were equivalent to the brand drug, it would be a great cost-saving benefit to the patient, which, is the main reason patients made the change. Generic medications are allowed to have different inactive ingredients than the brand name medication. This can include fillers, dyes or other ingredients not found in the brand name drug. These additives may cause problems for people with allergies or sensitivities.

 

There is growing evidence that switching from the brand name Keppra to the generic form of Keppra (Levetiracetam) can cause an increased recurrence of seizures. Many individuals have reported being seizure-free for years and then shortly after switching to the generic drug, they reported having seizures. When dealing with anti-convulsive drugs, the smallest variations in concentrations between the brand name and the generic formula, can be toxic, causing seizures when taken by epileptic patients. Just one seizure due to a change in the medication delivered, can be devastating to these patients. This can mean loss of driving privileges, injury, and even death. This change can also result in missed days at work or school. It has been noted that at least 59 percent of patients on Levetiracetam had recurrence of seizures. 49 percent noted a severity in side effects, such as vomiting and weakness. There are some cases of psychotic episodes.

 

In a study reported in the 2010 Journal of Epilepsia, it showed that the generic versions of Keppra did not perform equally to brand name Keppra.

 

Many of these patients were not given a choice to try the generic versions. In some cases, their health insurance companies dictated which medication they would cover. Many people assume the generics are exactly the same as the brand name, only cheaper. These generic drugs should not receive approval from the FDA if they are not exactly the same as the brand name, especially since patients cannot file a lawsuit if they experience serious side effects.

 

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