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Over 600 Adverse Events, Including Multiple Deaths, Reported to FDA Involving Abortion Pill RU-486 (Mifeprex)

Over a period of four years, there have been 607 serious adverse events associated with the so-called “abortion pill” RU-486 reported to the FDA. These include five deaths, 68 cases of severe bleeding that required transfusions, and 66 cases of infection.

RU-486 was approved in the U.S. by the FDA in September of 2000, for the termination of early pregnancies. Since then, over 460,000 doses have been administered, while the drug has been linked to a total of eight deaths.

The 607 complaints were reported between September 2000 and September 2004. Of these there were 237 cases of hemorrhage reported, with one resulting in death. 42 were determined to be life-threatening.

Of the reported cases of infection, there were seven incidences of septic shock ( when an infection enters the blood stream and endangers major organs) two of which ended in death.

Seventeen of the reported complications occurred because women had an undiagnosed ectopic pregnancy when they took the drug. Ectopic pregnancy occurs when the fertilized egg is implanted in an area outside the uterus, and can be deadly. Eleven cases resulted in ruptures and one in death.

Diagnosis of the potentially deadly compilcations of RU-486 is often delayed by the fact that the initial warning signs of serious illness, like abdominal cramping, nausea and vomiting are also frequent side effects of the drug itself.

The report of the hazardous complications incited a protest by the ant-abortion faction to remove the drug from the market. Researcher Dr. Margaret M. Gary, remarked to WebMD that  in her opinion the instances reported to the FDA make up only a fraction of the true medical problems that actually occur among RU-486 users. (The FDA has estimated that under-reporting can range as high as 90% to 99%).

Dr. Gary and co-author, Dr. Donna J. Harrison, are members of the American Association of Pro Life Obstetricians and Gynecologists, a group that advocates removal of RU-486 from the market.

In contrast, Harvard Medical School obstetrics and gynecology professor, Dr. Michael F. Greene, argued that underreporting of  complications may be less of a concern with RU-486 than with many other drugs because of the controversy surrounding it.

Dr. Greene says based on the current research it is difficult to determine whether RU-486 is safe or not. He says it is not clear if the drug is more dangerous than miscarriage or surgical abortion, or whether the deaths and other reported adverse events were caused by the drug. "I don’t have a dog in this fight. But I do believe very strongly that women should have access to safe pregnancy termination rather than being forced to undergo unsafe pregnancy termination. If the safest way of terminating a pregnancy turns out to be surgical, then so be it. But until we have more compelling data, no one should leap to conclusions."

The manufactures of the drug, also called Mifeprex declined to comment. Federal officials announced that the FDA is currently investigating the deaths and the reported negative events.

In November, considerable attention was focused on Mifeprex because of multiplte deaths among users of the drug from the same deadly bacteria, Clostridium sordellii, which is a rare and lethal bacterium for which there is no known cure once an infection takes hold.

At that time, the FDA as well as the Centers for Disease Control and Prevention (CDC) announced their intention to launch investigations into the possible link.

Mifeprex (RU-486), as an abortion pill, has been shrouded in controversy since 1996 when the federal advisory committee that recommended its approval was forced to meet under the protection of federal marshals.

Until now, no one had ever suggested or suspected that the drug and the infection might be linked in some way. With the confirmation that at least five women had died from Clostridium sordellii infections within days of taking the drug, medical experts were faced with far more than a coincidence. It had turned into a public safety issue that required a satisfactorily explanation.

Since four of the five deaths occurred in a cluster between September 2003 and May 2005 in California, there was speculation that contamination may have played a role in the fatal infections. Testing by the FDA, however, proved negative for any such contamination.

As a result, the decision was been made to convene a special meeting early in 2006 at which officials from the FDA and CDC will examine what has become a perplexing medical mystery. No doubt, the fifth death, which occurred in Canada during clinical testing of the drug in 2001, will now be reexamined.

In each of the deaths, Clostridium sordellii infected the woman’s uterus, flourished, and then entered their bloodstreams. Death occurred in each case within one week of taking the drug.

This deadly bacterium can cause nausea, vomiting, diarrhea, and weakness. Since fever may not occur, however, victims often succumb to toxic shock without ever realizing how sick they really were. Once the infection has flourished, antibiotics are often ineffective because even in death, the bacteria continue to release deadly toxins.

Many experts are concerned about these revelations for a number of reasons. One is that other similar deaths may be going unreported because the association between the drug and the infection has not been made. A second is the under-reporting issue discussed above.
A third is that some researchers believe the drug itself impairs the immune system and makes patients more vulnerable to infection with Clostridium sordellii. Dr. James McGregor, of the University of Southern California, discussed that theory earlier this year in two medical publications.

As a result, critics of the drug are again calling for its removal from the market pending the outcome of the combined FDA and CDC probe.

Warnings about the drug’s possible link with Clostridium sordellii were placed on Mifeprex’s label in July, and the FDA updated this information on its Web site on November 4, without announcement, after it discovered that all four California deaths involved the Clostridium sordellii bacterium.

Michelin Recalls Thousands of Tires with Potentially Dangerous Defects

The U.S. National Highway Traffic Safety Administration (NHTSA) and Transport Canada have been notified by Michelin North American that the international tire giant is recalling approximately 6,500 Michelin(R) Pilot(R) Sport 255/35ZR20 97Y Extra Load tires in the United States and Canada. The recall is specifically limited to the above mentioned tires only.
 
This decision came as a result of findings by Michelin’s own internal quality control system that the tires in question do not meet the company’s quality standards.

The defect in the affected tires ordinarily appears first as a visible blister on the sidewall of the tire that may produce a noticeable tire vibration, which a driver might detect.

The condition may also result in a rapid loss of air pressure, which could potentially lead to a loss of control and potential vehicle crash.
   
To date, there have been no accidents or injuries reported in North America. The majority of the tires affected by the recall were distributed in the U. S. with fewer than 400 distributed in Canada. Related actions are under way in other countries.
    
The recalled tires were fitted as original equipment on some trim levels of Jaguar XJ8 vehicles and also were available in the replacement market. The affected tires’ DOT markings begin with FHPNEFMX and end with 00, 01, 02, 03 or 05.  

The DOT code can be found on the sidewall right above the rim printed in small type less than half an inch tall. Consumers should first make sure of the tire’s make and model: Michelin(R) Pilot(R) Sport 255/35ZR20 97Y Extra Load.  

Next, the DOT code on the sidewall should be examined. Affected tires have a DOT code that begins with FHPNEFMX and ends with 00, 01, 02, 03, or 05 as the final two digits.   

Consumers who have difficulty identifying a tire’s DOT code should ask for assistance at a local tire dealer or call Michelin Consumer Relations at 1-800-847-3435 (1-888-871-4444 in Canada). A photo of an affected tire can be found online at:   http://www.newscom.com/cgi-bin/prnh/20051229/CLTH002.

The first two characters FH designate the tire’s manufacturer and plant code. The third and fourth characters denote the tire size. The fifth, sixth, eleventh, and eighth (optional) characters identify the brand as well as other significant characteristics.

The final four numbers denote the date the tire was produced with the first two indicating the week and the last two numbers indicating the year (05 indicates the tire was built in 2005).

The company will be replacing all potentially defective tires in a comprehensive commitment to retrieve from the market any tire that does not meet Michelin quality standards. Replacement tires are available at no cost (including mounting and balancing) to consumers through Michelin tire dealers.
    
Any consumer in the United States or Canada who believes they are affected by the recall should not wait to receive notification but should call Michelin Consumer Relations at 1-800-847-3435 (1-888-871-4444 in Canada) or return to their servicing tire dealer for a free inspection and replacement of affected tires

Since the potential defect is one that could cause a serious or even fatal accident, consumers should examine their Michelin tires immediately and not hesitate to have any tire affected by the recall replaced as soon as possible.

Studies and Lawsuits Point Accusing Fingers at the Parkinson’s Drug, MIRAPEX, that Has Been Linked to Compulsive Gambling

It is admittedly an odd connection but there seems to be no real doubt that MIRAPEX, a drug used to treat Parkinson’s disease (PD), is also responsible for turning some of the patients who used it into gambling addicts.

In July, a Mayo Clinic study published in the Archives of Neurology that identified 11 Parkinson’s patients who developed a gambling habit while taking MIRAPEX or similar drugs between 2002 and 2004. Since the study was released, 14 additional Mayo patients have been diagnosed with the problem according to lead author Dr. M Leann Dodd, a psychiatrist at the Clinic.

Previously, in August 2003 in the journal Neurology, Drs. E. Driver-Dunckley, J. Samanta, and M. Stacey published an article entitled “Pathological gambling associated with dopamine agonist therapy in Parkinson’s disease.”   

That study found extreme cases of compulsive gambling in nine (of 1,884) patients using pramipexole (8 or 1.5%)) and pergolide (1 or 0.3%). Both results were well above the overall incidence rate of all PD patients of 0.05%. Both drugs that showed an increased risk were dopamine agonists (DA).

The Mayo Clinic study also analyzed the findings in five prior studies (including the 2003 Driver-Dunckley study) and confirmed that: “All of the commonly prescribed dopamine agonists have been associated with pathological gambling” with pramipexole being “disproportionately represented in both our series (82% of our patients) and in prior reports (59%).”

MIRAPEX (pramipexole dihydrochloride) is in the dopamine agonist class of drugs and is believed to work by mimicking the action of dopamine in the brain to help control the symptoms of Parkinson’s disease. Dopamine also affects brain processes that control emotional responses and a person’s ability to experience pleasure and pain. It is thought to play a role in addictive behavior.

Unfortunately, this is another drug whose benefits come with a very high price tag for some patients. The ones who become addicted to gambling often wind up losing their life savings, fall deeply into debt, and even jeopardize or destroy their marriages or other personal or family relationships.

In the past, the victims of this harsh side-effect had no idea what had come over them. Their brain was literally taken over and their gambling became constant and compulsive. Simply stated, they were out of control and had no idea why. For these people, the situation was frightening and inexplicable.

As a result of this completely bizarre and damaging side-effect, many MIRAPEX users suffered long periods of debilitating and destructive behavior during which they were unaware that the drug was causing the problem and that it would cease if they discontinued taking it.

MIRAPEX is manufactured by German-based Boehringer Ingelheim Pharmaceuticals, the world’s biggest family-owned drug company, in cooperation with New York-based Pfizer, the world’s largest drugmaker. Its sales for 2004 topped $200 million in the U.S. alone.
.Boehringer Ingelheim lists "compulsive behaviors (including sexual and pathological gambling)" as a possible side effect associated with taking MIRAPEX.  That seven-word phrase on page 17 of a 21-page highly technical document is all the warning that is given concerning the potentially detrimental side-effect.

While Boehringer-Ingelheim has repeatedly claimed there is no scientific evidence upon which to base the conclusion that MIRAPEX causes addictive or compulsive behavior, the multiple reputable studies on the subject would seem to indicate otherwise. In addition, the company revised its package insert to include the warning with respect to “compulsive behavior” despite its denial of the connection.

Currently, two major lawsuits against Boehringer Ingelheim and Pfizer have been commenced in federal court in California and in Superior Court in Ontario, Canada. They allege a number of addictive behaviors associated with MIRAPEX including gambling, shopping, having sex, eating, and engaging in other compulsive conduct.

It is likely that additional lawsuits will be commenced in the near future since the problem is as widespread as the locations of people who took MIRAPEX.

Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation nationwide, told us that: “It is difficult to imagine how the manufacturers of MIRAPEX can maintain there is no scientific evidence to support the addiction link when several studies leave little doubt of the connection. In addition, it is rather amazing that when the manufacturers finally decided to add a warning regarding compulsive conduct to the product insert they chose to hide it in the middle of 21 pages of technical data.”

Arsenic-Treated Lumber Poses Long-Term Toxic Threat with Particularly Serious Consequences for Children

The University of Florida has issued a press release setting forth some of the details of a study by researchers from the University of Miami, the University of Florida, and Florida International University that “examined the potential consequences of arsenic leaching from chromated copper arsenate, or CCA-treated wood, from a real deck as well as from simulated landfills.”

The troubling conclusions of the two research papers published in the online version of the journal Environmental Science & Technology Research are that: (1) “Arsenic from treated lumber used in decks, utility poles and fences will likely leach into the environment for decades to come, possibly threatening groundwater; and (2) “The deck wood leached high levels of arsenic into rainwater runoff and the soil and treated wood only continued leaching arsenic while sitting in simulated landfills.”

 “What’s important for people to realize is that arsenic is relatively mobile, so it’s something we have to be relatively concerned about how to manage this huge stock of CCA wood that remains to be disposed of,” said Tim Townsend, a UF associate professor of environmental engineering.

Previous studies relating to the arsenic leaching problem prompted the wood-products industry to phase out CCA-products for residential use in 2003, but CCA-wood can still be used in utility poles and industrial timbers.

One of the conclusions of a study conducted by Helena Solo-Gabriele, a professor of environmental engineering at the University of Miami, Townsend studied rainwater runoff from a CCA-treated deck for a year. Their conclusion: Arsenic contamination was 100 times higher than runoff from an untreated deck.

In addition, “a layer of sand underneath the deck had arsenic levels 15 to 30 times higher than background levels, while water that percolated through the sand also was contaminated by the toxic metal.”

While it was found that only “a small fraction leaches in any given year,” the problem was that the treated wood can be in the ground for several years and, thus, “the impacts can be significant, especially given the high concentrations of arsenic in the wood itself.”

By their calculations, the researchers estimated that by 2000, Florida had already imported some 28,000 metric tons of arsenic, of which, 4,600 metric tons has already leached into the environment. They projected up to 11,000 additional tons of arsenic will leach from decks and other structures over the next 40 years.

All of this raises the suggestion that those charged with the removal and disposal of CCA-treated wood may want to be cautious in selecting whether the final resting place for the contaminated wood once it is taken out of service should be lined or unlined landfills.

These future considerations do not, however, address the serious problem posed by a mathematical model based on the researchers’ experiments that estimated between 20 and 50 tons of arsenic may have already leached into construction and demolition landfills in Florida before 2000, with an expected increase of between 350 and 830 tons of the heavy metal by 2040.

Under current Florida law, construction-and-demolition landfills are not required to be equipped with linings. This could pose a long-term contamination problem with respect to groundwater around those landfills, according to John Schert, director of the Florida Center for Solid and Hazardous Waste Management.

“The leaching research conducted by the team suggests that arsenic contamination of the groundwater under these landfills may be a large future problem that future generations have to deal with,” Schert said.

One possible solution is to require linings, Schert said. However, that might put many of the landfills out of business.

“This would probably lead to much more illegal dumping of construction-and-demolition waste in remote, rural, and agricultural locations,” he said. “Illegal dumping of construction and demolition waste in Florida is already a big problem.”

In addition to the results of the recent Florida studies, however, are the broader problems posed by arsenic-treated lumber across the U.S. especially in playground building materials and other wood used in applications where it comes into direct contact with humans in general and children in particular.

Arsenic is a naturally occurring element that is found throughout the environment. It is usually combined with other elements such as oxygen, chlorine, and sulfur to form inorganic compounds. When combined with hydrogen and carbon, arsenic forms organic compounds.

Although most people are aware of pure arsenic when it is intentionally used as a poison, it is when inorganic arsenic compounds are used to preserve wood and organic arsenic compounds are used as pesticides (particularly on cotton plants) that arsenic can present a serious health threat.

In 2001, several articles were written regarding the dangers of arsenic-treated wood used for decks, patio furniture, benches, and playground equipment. About 80% of outdoor lumber is treated with chromated copper arsenate (CCA) composed of copper and arsenic used to repel insects, kill molds and fungi and retard rot, and chromium used to stabilize the two other chemicals.

While the chemicals can stay in the wood for 10 years or more, they can also slowly leach out of the wood and become dangerous to both children and adults. In the environment, arsenic cannot be destroyed; it can only change its form. Arsenic in the air settles to the ground on its own or is washed to the ground by rain. Many arsenic compounds are water soluble.

Ninety-eight percent of outdoor wood sold in the U.S. is treated with CCA and in Florida alone; nearly 30,000 tons of arsenic is believed to be at large.

Children are particularly vulnerable to CCA poisoning as they are more likely to play on floorboards or playground equipment and then put their hands in their mouths. Arsenic has been linked to birth defects in animals exposed to inorganic arsenic.

Adults, especially workers and do-it-your-selfers are also at risk as the inhalation or ingestion of the sawdust can be harmful. Other sources of arsenic exposure are smoke from burning (treated) wood, eating or drinking contaminated food or water, hazardous waste dumps, living in areas with high natural levels of arsenic in rocks.

Prolonged exposure to CCA can lead to nerve damage, dizziness, numbness, and an increased risk of bladder, lung, and skin cancer. The World Health Organization (“WHO”), the Department of Health and Human Services (“DHHS”) and the EPA have all determined that inorganic arsenic is a human carcinogen. Arsenic can give you sore throats and irritated lungs.

It may cause nausea and vomiting, decreased production of red and white blood cells, abnormal heart rhythm, and “pins and needles” sensation in the hands and feet. Arsenic may cause small corns or warts on the palms, soles, and torso. In sufficient quantities, arsenic will cause death.

Consumers should remember to ask retailers if the wood they are purchasing is arsenic-treated as the warnings provided by suppliers may be discarded with the packing material before the wood is sold.

A report issued by the National Academy of Sciences in September of 2001 showed that the Environmental Protection Agency had completely underestimated the cancer risks of arsenic in drinking water. The reports claimed that cancer risks are high even for seemingly low levels of arsenic in tap water.

The current standard of 50 parts per billion of arsenic in drinking water, which was established in 1942, is no longer acceptable as the risk of bladder and lung cancer is high even at just 3 ppb. The report also addressed other serious arsenic-related health effects such as heart disease, high blood pressure, and diabetes.

There are tests to determine the exact level of arsenic in the blood, hair, urine, and finger nails. The urine test is used to detect recent exposure while the hair and nail tests are used to measure long term exposure and past exposure (6-12 months before).

Children are particularly vulnerable to arsenic exposure since they spend much of their time playing on wooden playground structures and on decks. These surfaces, a Canadian Study revealed, may expose children to significant levels of arsenic.

Until 2003, the wood used to make such structures was treated with the preservative chromated copper arsenate (CCA). A study published in the October 2004 issue of Environmental Health Perspectives found that children who play on wooden structures treated with CCA were left with more arsenic on their hands than children playing on other wooden sets.

To collect data, researchers from University of Alberta examined the hands of 66 children playing in 8 CCA playgrounds and compared them to the hands of 64 kids playing in 8 CCA-free playgrounds. After play, children washed their hands in a bag containing water. The solution was then analyzed for the presence of arsenic.

On average, the researchers found that kids playing in CCA playgrounds had more arsenic on their hands (.5 mcg compared to .095 mcg) than the other children. The amount found from CCA playgrounds ranged as high as 3.5 mcg.

exposure to higher concentrations of arsenic (200 mcg/L) in drinking water have been tied to an increase cancerous tumor growth, and to the existence of skin and bladder cancer.  Below that level, meaningful research on the subject remains to be conducted.

Also unknown is how exposure to arsenic in drinking water compares to children’s exposure to small doses of arsenic on the playground.

Still, any level of exposure to a known carcinogenic toxin is unsettling, particularly if the exposure is occurring in a location where children spend a lot of time and are presumed to be safe.

But what are the possibilities for reducing the risk of illness and health problems to children due to exposure to the poisons and pesticides around them?

The researchers from University of Alberta urge parents to have their kids always wash their hands thoroughly after playing on structures that are coated with CCA.

Another possible solution is to coat the wood with an oil or water-based sealant so that the arsenic cannot get onto children’s’ hands.

The Environmental Protection Agency (EPA) revealed in May of 2004 that an ongoing study with the Consumer Products Safety Commission (CPSC) found that a yearly coating of such a sealant could cut down on arsenic exposure.

Such preventative steps are surely worth taking, given the potential hazards of arsenic exposure. According to Dr. James Roberts, M.D., M.P.H., an associate professor of pediatrics at the Medical University of South Carolina in Charleston; “Arsenic in children’s bodies is a long-term exposure and the outcomes are often caner at a much later age.”

Physicians, Roberts said, must be aware of the risks children’s exposure to the poison so that they can urge families to follow EPA recommendations on treating CCA-coated wood. At this point, it’s the only type of protection available.

Heart Attack Patients Often Given Overdoses in ER

A study published in the Journal of the American Medical Association reports that overdoses of potent blood-thinning drugs given in hospital emergency rooms often put heart attack patients at risk for life-threatening episodes of internal bleeding.

The research conducted by lead author Dr. Karen Alexander of Duke University estimates that out of about 117,000 episodes of bleeding that occur every year in heart attack patients, approximately 15% are caused by overdoses and could be preventable.

The drugs that were included in the study were heparin, low molecular weight heparin, and glycoprotein IIb-IIIa blockers, often called "super-aspirins" for their blood-thinning properties.

These medicines, injected or given intravenously, are extremely successful at preventing clots and additional heart damage. Overdoses, however, can result in excessive bleeding at catheter sites including pre-existing stomach ulcers, and, most seriously, in the brain.

According to the researchers, overdoses occurred most often in thin people, women, the elderly and those with kidney problems. Some 42% of the 30,136 heart attack patients studied, who were treated in 2004 at 387 U.S. hospitals, were given excessive doses of blood thinners.
Those who were given excessive doses of either the molecular weight heparin or the "super-aspirin," the two newest drugs, had more than a 30% increased chance of major bleeding than those who received the proper dose.

Alexander says that correct doses should be computed according to age, gender, weight and kidney function, a process that sometimes requires a calculator. However, when heart attack victims are admitted to the hospital the need for fast action often causes doctors to either ask what the patient weighs or to "eyeball it.”

She hopes the current study “will increase awareness of how important it is to take that extra minute to complete these more careful calculations."

The study also indicated that patients who had received overdoses also had slightly longer hospital stays and higher death rates than those who got the correct dosages. That finding, however, might be because these patients happened to be sicker.

Acetaminophen Poisoning Now the Leading Cause of Acute Liver Failure in the U.S.

Most people are familiar with the fact that acetaminophen is a popular over-the-counter (OTC) pain reliever. What is generally not known by consumers, however, is just how widely used acetaminophen is or how dangerous it can be when misused.

Although acetaminophen is most commonly associated with Tylenol, it is also an active ingredient in hundreds of OTC (Excedrin, Midol Teen Formula, Theraflu, Alka-Seltzer Plus Cold Medicine, and NyQuil Cold and Flu) and prescription (Vicodin and Percocet) drugs. Thus, research has found that 36% of Americans take acetaminophen in some form at least once every month.

As a result of its widespread market disbursement, acetaminophen has gradually become associated with the group of medications (including aspirin, cough and throat lozenges, and antacids) that are no longer respected as being potentially dangerous. This casual treatment of any drug, especially acetaminophen, has had grave consequences indeed.

More than 10 years of medical research has found that in sufficient amounts, acetaminophen is toxic to the human liver. Thus, overdosing (intentional or unintentional) with the drug can cause acute liver failure. The public, however, has not seemed to have gotten the message.

Despite all of this information concerning the dangers associated with the drug generally and with overdosing specifically, the number of unintentional acetaminophen poisoning cases has continued to increase with dire results.         

According to the authors of a new study published in the December issue of Hepatology, which is the official journal of the American Association for the Study of Liver Diseases (AASLD): “Acetaminophen poisoning has become the most common cause of acute liver failure in the United States.”  Although many of those cases involve attempted suicides, almost 50% are the result of unintentional overdoses.

The problem with unintentional overdoses is that, unlike intentional overdoses, they are usually not recognized until significant liver damage has already occurred. Intentional overdoses can, and usually are, treated with N-acetylcysteine; unintentional overdoses rarely are.

The researchers conducted a prospective study of patients presenting with acute liver disease to 22 academic centers participating in the Acute Liver Failure Study Group. Of 662 consecutive patients between 1998 and 2003, 275 had acetaminophen-related acute liver failure.

Acute liver failure cases attributable to acetaminophen poisoning increased from 28% in 1998 to 51% in 2003. These patients were mostly female (74%) and Caucasian (88%). Suicide attempts accounted for 44% of the cases while 48% had overdosed unintentionally. This occurred by either by taking combinations of products containing acetaminophen or taking more than the recommended dosage of a single product over time.

Of all patients studied with acetaminophen-related acute liver failure, 74 died, 23 received liver transplants, and 178 survived without transplantation.
     
Prescription acetaminophen compounds accounted for 63% of the accidental overdoses and 38% of the subjects had been using two acetaminophen medications simultaneously. According to the researchers: "This suggests patients lack awareness of the hazards of over-the-counter acetaminophen use in combination with prescribed agents."  

A significant finding was that some patients reported taking less than 4 grams of acetaminophen per day before falling ill, thus: "Our data suggests that there is a narrow therapeutic margin and that consistent use of as little as 7.5 g/day may be hazardous." The data also suggest that there is no chronic form of acetaminophen injury, rather, a safety threshold that, when exceeded, has catastrophic results.

Dr. Tim Davern, a gastroenterologist with the liver transplant program of the University of California at San Francisco and one of the authors, observed: "I see some young women who have been suffering flu-like symptoms for the better part of a week, and not eating much. They start with Tylenol, and maybe add an over-the-counter flu medicine on top of that, and pretty soon they’ve been taking maybe six grams of acetaminophen a day for a number of days. In rare cases that can be enough to throw them into liver failure."

Each Extra Strength Tylenol tablet contains half a gram, or 500 milligrams, of acetaminophen, and arthritis-strength versions of the pain reliever contain 650 milligrams. One tablet of Midol Teen formula contains 500 milligrams of acetaminophen, as does one adult dose of NyQuil Cold and Flu. One dose of Tylenol Cold and Flu Severe contains 1,000 milligrams. The recommended maximum daily dose for adults is 4 grams, or 4,000 milligrams.

The diverse nature of the compounds containing acetaminophen and the difficulty consumers have in interpreting label information usually prevents consumers from keeping track of the cumulative amount of the drug they are taking on a daily basis. Because of this, many experts have urged the FDA to require large warnings to be placed on any product containing acetaminophen.

In proper doses, acetaminophen remains a very safe drug. The problem is that the safe dosage level can be easily exceeded by consumers who either take a little extra of one product to get the pain relief they need or take a number of remedies containing the drug without monitoring the cumulative dose of acetaminophen the products contain.

Another problem is that many narcotic/opiate (Vicodin, Percocet) or alcohol-based (NyQuil) compounds are often abused or taken in increasingly larger doses to achieve relief or because of addiction. As a result, the acetaminophen content is ignored and reaches dangerously high levels. 

Experts agree that most people can safely take the four-gram daily maximum that labels recommend for adults – the equivalent of eight Extra Strength Tylenol spread across 24 hours many even take much more without harm.

When eight grams in a single day is reached, however, a significant number of people whose livers have been stressed by anything from a virus or alcohol to other medications run the risk of developing serious problems. When a single dose reaches 12 to 15 grams, without immediate medical intervention, the death rate is about 50%.

While the researchers noted the incidence of acetaminophen overdose is still low compared to the millions of tablets consumed on a daily basis, their findings were considered startling enough to propose changes in the way acetaminophen is sold.

"Efforts to limit over-the-counter package size and to restrict the prescription of narcotic-acetaminophen combinations (or to separate the narcotic from the acetaminophen) may be necessary to reduce the incidence of this increasingly recognized but preventable cause of acute liver failure in the United States."

When it comes to acetaminophen, the simple warning issued by the makers of Tylenol says it all: “Anything more than the recommended dose is an overdose.”

The study was conducted by Dr. William Lee of the University of Texas Southwestern Medical Center and Dr. Anne Larson of the University of Washington Medical Center.

Since Many Drugs Lose Effectiveness after Expiration Date, Even Those That Do Not Should Be Discarded

A study done for the U.S. Army found that many drugs remain effective and usable even up to five years after their expiration date. Thus, some pharmaceutical experts do not believe all drugs should be automatically discarded immediately after they “expire.”

According to a report in HealthDay News, however, other experts think it is better to throw out all expired drugs rather than risk taking one that has become degraded or ineffective.

At the FDA science forum in 2002, the U.S. Army study was presented and revealed that 84% of the drugs examined (1,122 lots of 96 different drugs) remained stable up to 57 months after their listed expiration date.

Since these figures were found to vary widely from drug to drug, many pharmacists recommend that consumers take expiration dates seriously. The farther past the expiration date, the more unpredictable the effectiveness of the drug seems to be the message.

In fact, one study recently found that liquid antibiotics used to treat ear infections in children begin to lose their effectiveness after only two weeks even when refrigerated as required.

The Army study was also conducted under optimal circumstances where the drugs were kept in their original, unopened containers. Consumers simply do not do this since they usually take some of the medication before storing it away.

In addition to the obvious question of effectiveness, experts also point to other problems with taking “old” medicine. One is that the old drug may interact in an adverse way with new medications the patient may now be taking.  The dosage could also vary for different diseases or illnesses.

Since you can never be absolutely certain that you are getting the maximum benefit from an expired drug, it is recommended that you go through your medications once a year and discard any medicine that has already expired. 

Nine Wrongful Death Claims Brought Against Liver Transplant Program at University of California, Irvine Medical Center

In November, the University of California at Irvine Medical Center (UCI) suspended its liver transplant program after the government revoked its certification. 

Those actions came in the wake of a report by the Los Angeles Times concerning some 32 patients who died over the past two years while awaiting transplants while the hospital turned down 95 available donor organs.
The U.S. Centers for Medicare and Medicaid Services’ report, cited by the L.A. Times, found UCI had performed just five liver transplants this year and no more than eight a year between 2002 and 2004. The minimum number of transplants required to maintain federal funding is 12.

According to the report, the program failed to keep a transplant surgeon available full-time as required. Instead, it has contracted outside surgeons.

A letter from Medicare’s Chronic Care Policy Group Director Laurence D. Wilson noted that the one-year survival rate of Irvine liver transplant recipients (68 to 70%) fell well below the 77%  percent minimum needed to retain federal certification.

The case of a former UCI transplant patient, Elodie Irvine, prompted the federal inquiry. She had languished for four years on the hospital’s transplant list (1998 to 2002) despite promises that she would have a new liver within in anywhere from a week to a few months.

Eventually, after becoming suspicious, her kidney specialist advised her to transfer to another hospital where she received a liver transplant within only two months.

According to Ms. Irvine: “They let me sit and sit at home in bed for four years. I thought I was going to die. To be honest, most of my friends are dead. I watched them die one by one. They kept on telling us, ‘It’s soon, it’s soon.’”
By the time she received her transplant, her kidney and liver disease had severely worsened. Her liver had swelled to four times its normal size and the cysts on her diseased organs had begun to burst.

According to the L.A. Times, when Irvine sued UCI she was shocked to learn that the hospital had turned down 38 livers and 57 kidneys that were offered in her name. Although the 51-year-old mother settled with UCI earlier this year for an undisclosed amount, her lawsuit prompted the federal inquiry that lead to the hospital’s decertification.
While Irvine had survived her ordeal, many others were not as fortunate. Some 32 patients died while waiting liver transplants from UCI. According to federal records, between August 2004 and July 2005, UCI received 122 liver offers but transplanted only 12.

Now comes word that nine families whose relatives died while waiting for liver transplants have filed wrongful death lawsuits claiming the transplant program at the University of California, Irvine Medical Center accepted new patients when hospital officials knew they didn’t have the ability to perform transplants.

The combined lawsuits were filed in Orange County Superior Court and name the University of California, Irvine Medical Center, staff doctors, the former head of the transplant program, and the University of California regents as defendants.


            
            

CPSC, Recreational Equipment Inc. Announce Recall of 2,800 Children's Bicycles

The Consumer Products Safety Commission has announced the following product safety recall being conducted by Recreational Equipment Inc., of Kent, Washington. Consumers should stop using the product immediately unless otherwise instructed.

Some 2,800 Novara Dirt Rider 20-inch 5-Speed and 6-Speed Bicycles are the subject of the recall. The alloy frame used for these bicycles can be prone to fatigue failure.

Frame failure results in the separation of the fork, head tube, and handlebar away from the rest of the bike causing a loss of control and crash, and posing a risk of serious injury to the rider. REI has received four reports of frames failing. All four failures resulted in crashes with one child sustaining a minor injury.

The Novara Dirt Rider 20-inch 5-speed and 6-speed bicycles are children’s bicycles with 20-inch wheels, an aluminum frame, and multiple speeds. 2003-2004 model year bicycles were red/black or silver/blue frost in color; 2005-2006 model year bicycles were black/gravel or white/powder blue in color.

The bikes being recalled, which were manufactured in China, were sold at REI stores from October 2002 through November 2005 for between $200 and $210 (depending on model year) full price and may have been sold as low as $125 on sale.

Consumers should immediately stop using these bicycles and return them to the nearest REI store for a full refund or credit.

For additional information contact REI at (800) 426-4840 between 4 a.m. and 11 p.m. PT seven days a week, or visit REI online at www.rei.com or contact your local REI store.

Brake Problem Forces General Motors to Expand SUV and Truck Recall to a Total of 1,357,000 Vehicles

A recall that began in August with 804,000 full-size pickup trucks and SUVs in 14 states has been extended to include an additional 553,000 vehicles and six more states as well as the District of Columbia, according to General Motors Corp.

The problem involved is the unwanted application of the anti-lock brake system that can cause increased stopping distances during low-speed braking. More than 200 crashes and some minor injuries have been linked to the problem described in the recall.

All of the affected vehicles are from the 1999 to 2002 model years. The specific vehicles being recalled include the Chevrolet Avalanche and Silverado pickups and the Chevrolet Suburban and Tahoe SUVs. The GMC Sierra pickup and Yukon and Yukon XL SUVs are also affected.

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