A new study at the VA Connecticut Healthcare System, New Haven, Connecticut found that those taking atypical antipsychotic drugs may be at risk for developing high blood sugar (hyperglycemia).

The research, which was conducted by a team led by Dr. Michael J. Sernyak, monitored the frequency of undiagnosed high blood sugar in 647 patients taking various atypical antipsychotics, including: Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), or Geodon (ziprasadone). Over the course of two years, 153 of the participants had a fasting blood sugar result.

The study’s findings, published in the Journal of Clinical Psychiatry for December 2005, show that blood sugar levels were normal for 70% of the subjects, raised in 25% and extremely elevated in just over 5% of the participants.

Race, ethnicity, age, body mass index (BMI), or psychiatric diagnosis did not appear to have an impact on the development of high blood sugar.

Of all the antipsychotic medications, Clozaril was found to raise blood sugar in significantly more individuals than any of the other medications. The researchers did not find substantial differences for any of the other drugs.

According to the study, almost one in three patients taking atypical antipsychotics who thought their blood sugar levels were normal actually had abnormalities. The authors believe this finding should prompt the implementation of periodic screening even in large outpatient populations.

On June 10, newsinfern.com reported that Eli Lilly had agreed to pay $690 million to settle some 8,000 claims regarding its failure to adequately warn patients that Zyprexa posed an increased risk of diabetes and hyperglycemia.

Specifically, the claims were based on allegations that prior to September 2003, Lilly failed to adequately warn those taking Zyprexa of an increased risk of developing diabetes, hyperglycemia, and related illnesses.

While the pharmaceutical giant did not admit its best-selling drug caused the injuries in question, its potential exposure in the litigation far exceeded the settlement figure. Thus, as a business decision, resolving about 75% of the claims six months before trial made sense.

At the time, Jerrold S. Parker, senior partner in the prominent New York personal injury law firm of Parker & Waichman, told reporters that: “It’s really remarkable to arrive at a settlement of this magnitude so far in advance of trial.”

Mr. Parker said that the plaintiffs’ litigation team, made up of some of the foremost products liability attorneys, “was able to convince Lilly that plaintiffs’ case was a strong one, with a good likelihood of success, if it proceeded to trial.                                 
 
The fund will be administered by a panel named by the plaintiffs’ attorneys which will allocate compensation to the plaintiffs based mostly on the extent of their injuries which range from weight gain to death.

Zyprexa, like two other powerful antipsychotic drugs, Risperdal (Jannsen Pharmaceuticals) and Seroquel (AstraZeneca), has been found to cause serious side effects in patients, especially those who have already been diagnosed with diabetes and related illnesses.

Knowledge of the dangers of Zyprexa was discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug.

One of these cases resulted in death due to necrotizing pancreatitis, a condition in which cells in the pancreas die. In May 2003, forty additional reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.

An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug.

In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and other anti-psychotics and their link to the development of diabetes. The article estimated that somewhere around 11 million people have taken Zyprexa.

An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died. Although the FDA was aware of these cases, it did not require Lilly (and the manufactures of similar antipsychotic drugs) to add a significant warning regarding these risks until September 2003.

Zyprexa has been prescribed to more than 17 million people worldwide since it was first marketed in 1996.  It became Lilly’s best selling medication, after Prozac lost U.S. patent protection in 2001, with annual sales of $4.4 billion or almost 33% of Lilly’s total sales of $13.86 billion.

The results of the newest study serve to confirm the findings reached in previous research as well as the validity of the claims that prompted Lilly’s settlement in June.

A new study at the VA Connecticut Healthcare System, New Haven, Connecticut found that those taking atypical antipsychotic drugs may be at risk for developing high blood sugar (hyperglycemia).

The research, which was conducted by a team led by Dr. Michael J. Sernyak, monitored the frequency of undiagnosed high blood sugar in 647 patients taking various atypical antipsychotics, including: Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), or Geodon (ziprasadone). Over the course of two years, 153 of the participants had a fasting blood sugar result.

The study’s findings, published in the Journal of Clinical Psychiatry for December 2005, show that blood sugar levels were normal for 70% of the subjects, raised in 25% and extremely elevated in just over 5% of the participants.

Race, ethnicity, age, body mass index (BMI), or psychiatric diagnosis did not appear to have an impact on the development of high blood sugar.

Of all the antipsychotic medications, Clozaril was found to raise blood sugar in significantly more individuals than any of the other medications. The researchers did not find substantial differences for any of the other drugs.

According to the study, almost one in three patients taking atypical antipsychotics who thought their blood sugar levels were normal actually had abnormalities. The authors believe this finding should prompt the implementation of periodic screening even in large outpatient populations.

On June 10, newsinfern.com reported that Eli Lilly had agreed to pay $690 million to settle some 8,000 claims regarding its failure to adequately warn patients that Zyprexa posed an increased risk of diabetes and hyperglycemia.

Specifically, the claims were based on allegations that prior to September 2003, Lilly failed to adequately warn those taking Zyprexa of an increased risk of developing diabetes, hyperglycemia, and related illnesses.

While the pharmaceutical giant did not admit its best-selling drug caused the injuries in question, its potential exposure in the litigation far exceeded the settlement figure. Thus, as a business decision, resolving about 75% of the claims six months before trial made sense.

At the time, Jerrold S. Parker, senior partner in the prominent New York personal injury law firm of Parker & Waichman, told reporters that: “It’s really remarkable to arrive at a settlement of this magnitude so far in advance of trial.”

Mr. Parker said that the plaintiffs’ litigation team, made up of some of the foremost products liability attorneys, “was able to convince Lilly that plaintiffs’ case was a strong one, with a good likelihood of success, if it proceeded to trial.                                 
 
The fund will be administered by a panel named by the plaintiffs’ attorneys which will allocate compensation to the plaintiffs based mostly on the extent of their injuries which range from weight gain to death.

Zyprexa, like two other powerful antipsychotic drugs, Risperdal (Jannsen Pharmaceuticals) and Seroquel (AstraZeneca), has been found to cause serious side effects in patients, especially those who have already been diagnosed with diabetes and related illnesses.

Knowledge of the dangers of Zyprexa was discovered as a result of a series of findings beginning in 2001 when the FDA was alerted to 19 case reports of diabetes associated with the drug.

One of these cases resulted in death due to necrotizing pancreatitis, a condition in which cells in the pancreas die. In May 2003, forty additional reports of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes were received in the UK including one which proved to be fatal.

An emergency report issued by the Japanese Health and Welfare Ministry in April of 2002 concerning the side effects of Zyprexa noted that there had been two deaths of patients who had diabetes prior to taking the anti-psychotic medication. It also reported that there had been seven other patients who lost consciousness or slipped into comas after taking the drug.

In April of 2003, the Wall Street Journal ran a front page article on Zyprexa and other anti-psychotics and their link to the development of diabetes. The article estimated that somewhere around 11 million people have taken Zyprexa.

An eight-year study found that nearly 300 patients developed diabetes, 75 became seriously ill, and 23 died. Although the FDA was aware of these cases, it did not require Lilly (and the manufactures of similar antipsychotic drugs) to add a significant warning regarding these risks until September 2003.

Zyprexa has been prescribed to more than 17 million people worldwide since it was first marketed in 1996.  It became Lilly’s best selling medication, after Prozac lost U.S. patent protection in 2001, with annual sales of $4.4 billion or almost 33% of Lilly’s total sales of $13.86 billion.

The results of the newest study serve to confirm the findings reached in previous research as well as the validity of the claims that prompted Lilly’s settlement in June.

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 flulike 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.”

According to a new study by the Agricultural Health Study, a government funded program established in 1993 to examine the negative effects of pesticides on farming families in Iowa and North Carolina, regular exposure to the pesticide diazinon may cause lung and other types of cancer.

Diazinon (an organophosphate) is a pesticide that is derived from nerve gases that were introduced during World War II. In 2004 the chemical was removed from use in garden and lawn products because of evidence the substance could cause neurological disorders and other health problems that were not cancerous.

The findings of the recent study suggest a link between diazinon and lung cancer. Data showed that in 2002, 301 of 4,961 men who were exposed to the chemical in the workplace had developed lung cancer while only 968 of 18,145 of  the subjects without daily exposure to the chemical got cancer.

In the report published in the American Journal of Epidemiology, Dr. Michael C. R. Alavanja from the National Cancer Institute in Rockville, Maryland, and his colleagues stated: "We found evidence of an association of lung cancer and leukemia risk with increasing lifetime exposure days to diazinon."

The results corroborate a previous report by Agricultural Health Study which covered a less extensive period of time. The findings were also not impacted when cigarette smoking was accounted for, indicating that cigarettes do not explain the increased risk of lung cancer.

Although in a 1997 review of diazinon, the EPA classified the chemical as "not likely a human carcinogen" based on studies in rodents, the results from Agricultural Health Study confirms other laboratory and epidemiologic data that suggests the pesticide does pose a risk.

In response the EPA has offered to institute new restrictions on diazinon’s use. According to the 2004 data, about 4 million pounds of the chemical was applied agriculturally in America.

Beginning in January 2008 Illinois law will require state hospitals to report 24 types of careless mistakes called "never events."  These unacceptable blunders, including operating on the wrong limb, leaving a surgical sponge behind, using the wrong blood type, or killing a patient with a drug overdose, while unfortunate, are fairly frequent.

The new law, endorsed by the Illinois Hospital Association, stipulates that hospitals must examine the cause of the mistakes and institute a remedy for each one. In turn, the patients and health care workers involved will remain anonymous and the reports will not be used in malpractice lawsuits or for disciplinary action by the State.

Illinois is the fourth state to adopt the “never event law” and has also instituted other laws to maintain hospital standards and protect patients. Hospitals will undergo public inspection and will have to provide infection rates, nurse staffing, and mortality rates

William Barron, vice president of quality and patient safety at Loyola University Health System, spoke in favor of the new measures. "There will be a lot of angst over public reporting. But I have not heard anyone state they will not comply with the act for fear of being publicly humiliated. There’s an evolving cultural change. It’s all about transparency in health care, which by and large is a good thing."

As the number of prescription and over-the-counter drugs has steadily increased, so have the medical problems associated with dangerous side-effects and interactions.

One very serious problem caused by the sheer number of drugs, however, is the existence of similar sounding names for drugs that are intended to treat vastly different conditions. These mix-ups can be deadly as a recent case in Massachusetts illustrates.

In September, we reported on the death of an elderly man who entered Brockton Hospital in Boston with bipolar disorder. He was lucid and had no life-threatening illnesses. Unfortunately, four days later he was dead; killed by a massive dose of the wrong medication.

The patient was given 60 times the recommended dose of Librium when he was supposed to have received Lithium.

Even after a nurse discovered the initial mistake, the hospital continued to give the man other antidepressants and sedatives. He also received two doses of antibiotics over six hours late.

The hospital attempted to engage in damage control by claiming telling The Patriot Ledger that autopsy results showed the man had died of pneumonia.

According to a hospital spokesman: "When the error was found the doctor and the patient’s family were immediately notified. Brockton Hospital immediately launched an investigation and has taken several steps to ensure that this will not happen again."

The errors started when a pharmacist ordered Librium, a sedative taken for anxiety, for the patient instead of Lithium, which he was the drug actually prescribed for his bipolar disorder.

Amazingly, the pharmacist told investigators that even though he realized his mistake immediately, after failing to reach a nurse by telephone, he “forgot to follow through” on the matter. There was plenty of time in which to correct the mistake since the medication was not administered until the next morning.

While the two drugs have similar sounding names, the safe dosage for each is vastly different. A safe dose of Lithium runs up to 600 milligrams a day. The recommended dose of Librium for elderly people, however, is but 5 milligrams two to four times daily.

Thus, the patient received 300 milligrams of Librium, a full 60 times the safe dose of a drug he wasn’t even supposed to receive.
    
Another potentially serious mix-up that warrants another review exists between three drugs with similar names but vastly different effects have led to serious health problems. The drugs are:

• TOPROL-XL® (metoprolol succinate) – AstraZeneca – a beta blocker used to treat high blood pressure, heart failure, and angina used to treat hypertension, chest pain and some kinds of heart failure.
• TOPAMAX® (topiramate) – Ortho-McNeil Neurologics Inc. –  used to treat epilepsy and to prevent migraines.
•  TEGRETOL® (carbamazepine) – Novartis – used to treat some kinds of seizures and trigeminal neuralgia (a nerve disorder that causes stabbing head pain). 
  

The FDA and AstraZeneca, have advised doctors that patients who received the wrong drugs reported recurrences of seizures, hallucinations, and hypertension. At least one suicide attempt was possibly linked to failing to receive the right drug, and at least one patient who erroneously received Toprol-XL experienced a dangerous drop in heart rate.

In addition, a priority educational marketing campaign was launched by Ortho-McNeil Neuologics, Inc., to warn healthcare professionals about the possibility of confusion between its product TOPROL-XL® extended-release tablets and TOPAMAX® tablets.

The FDA and other health authorities have received a number of reports from patients receiving one of the drugs instead of the other. These mix-ups have occurred when prescriptions were written incorrectly, read incorrectly, or labeled incorrectly.

Although taking the wrong medication for a specific health problem is always problematic and may pose serious health consequences, this particular situation is extremely dangerous given the severity of the conditions that both drugs are designed to treat.

Patients with epilepsy can experience seizures if they miss doses of their TOPAMAX® therapy. Patients who are on TOPROL-XL® therapy run the risk of heart attack or experiencing angina if they interrupt their drug therapy.

The companies involved have alerted medical professionals nationwide of the problem by letter. They are also establishing direct contact between national pharmacy chains and state and national pharmacy groups. The companies will also issue recommendations to drug information database managers to create “pop-up” alerts regarding the potential for errors.
 
Ortho-McNeil Neurologics, Inc. has also offered the following suggestions to physicians: are urged to:

• Be alert to the possibility of medication errors in patients prescribed either TOPAMAX® or TOPROL-XL®.
• Be aware of the possibility of medication errors in any patients presenting with unexpected signs or symptoms while on TOPAMAX® or TOPROL-XL®.
• When either drug is prescribed, confirm the brand and generic names and dosage prescribed on written and oral prescriptions.
• When dealing with these drugs in particular, print legible prescriptions that include the brand and generic names, with indication.
• Counsel patients specifically about the brand name, indication, and proper use of each medication.

In addition, pharmacists are being urged to:

• Separate the two drugs from one another on the stock shelf.
• Place the shelf-talker provided in the Dear Pharmacist communication on the stock shelf.
• Be sure to confirm the brand and generic names prescribed on written and oral prescriptions when either of these drugs is involved.
• Confirm the brand and generic names when communicating the drug names within the pharmacy.
• Write full and legible prescriptions for these products and communicate oral prescriptions clearly.
• Counsel patients about the brand name, indication, and proper use of each medication.

Drug database content providers are urged to:

• Install sound-alike/look-alike name alert warnings for the name pair confusion.
• Use "tall man" lettering to highlight the end of each name.
•  Avoid the use of confusing or non-distinguishing drug mnemonics such as "TOP."
• Use brand and generic names when communicating the drug names.

Finally, patients should:

• Get printed information about the medication from the pharmacist when picking up a prescription for either drug.
• Become better informed about their medications by knowing the brand name of each medication, what the medications looks like, and what side-effects they may experience.
• Look at the medication before they take it. If it does not look like what they usually take, they should contact their healthcare professional immediately to find out why.
• Keep medications in the original, labeled containers to help identify each pill and follow proper directions.
• Ask their healthcare professional for more information if they have any questions about their medications, including the benefits and risks.

Medical professionals who encounter any medication error involving TOPAMAX® should report them immediately to Ortho-McNeil Neurologics, Inc., at 1-800-682-6532, and, if TOPROL-XL® is involved, also to AstraZeneca at 1-800-236-9933.

A new study supported by the American Gastroenterological Association (AGA) has found that many people misuse prescription and over-the-counter painkillers (OTC), also known as non-steroidal anti-inflammatory drugs (NSAIDs) and are ignorant to the potential side effects of the drugs. The study can be found in this month’s issue of the Journal of Rheumatology.

The nationwide survey of adult households in the United States sought to determine perceptions and knowledge of NSAIDs. Researchers defined NSAID users as those people who used prescription or OTC painkillers at least twice in the year prior to the survey for at least five consecutive days at a time.

Of the 807 people studied, 545 were unaware of the potential side effects of the drugs, while 18% had previously experienced side-effects.

The most commonly experienced side effects were stomach pain, internal bleeding and ulcers. Nearly 30% of these people did not believe that they were at risk for any side effects associated with the drugs.

Over 36 million people take OTC and prescription NSAIDs for pain relief, headaches, and arthritis everyday. Nearly 25% of people exceed the recommended dosage.

There is an increased risk of gastrointestinal complications, from stomach pain to ulcers, hemorrhage, and severe gastrointestinal problems associated with long-term use of NSAIDs in high doses, despite their many benefits.

Experts say that each year, these side-effects cause nearly 103,000 hospitalizations and 16,500 deaths.

In 2003, the AGA launched the R.E.D.U.C.E. (Risk Education to Decrease Ulcer Complications and Their Effects from NSAIDs) Campaign to educate the public about the potentially harmful effects of NSAIDs.

For more information about the risks of NSAIDs, visit http://www.2reduce.org.

Mifeprex (RU486) is the abortion pill that 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. Clostridium sordellii is a rare and lethal bacterium for which there is no known cure once an infection takes hold.

No one had ever suggested or suspected that the two might be linked in some way. That is until now.

With the confirmation that at least five women have died from Clostridium sordellii infections within days of taking the drug, medical experts are now faced with far more than a coincidence and a public safety issue that must be satisfactorily explained by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

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 has 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. Another is the well known fact that in the case of any problematic drug, a significant number of adverse reactions are simply not reported to the FDA or the manufacturer.

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 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 CalifornCalifornia deaths involved the Clostridium sordellii bacterium.

An Illinois heart surgeon, who encountered a malfunctioning defibrillator during an emergency coronary artery bypass operation, advised the patient’s family to “see an attorney” following the surgery at Belleville Memorial Hospital in Belleville, Illinois on November 11, 2003.

The patient, William Carvelot, who survived the surgery but who allegedly suffered neurological problems as a result of oxygen deprivation, took his doctor’s advice and sued both the hospital and the doctor himself.
According to the complaint, Dr. Bill Daily performed the emergency coronary artery bypass when Carvelot went into ventricular fibrillation and had difficulty breathing. CPR was initiated and lasted more than 15 minutes.

During that time, defibrillation was attempted but the machine did not work. The complaint claims that the machine was not programmed properly: its synch mode was incorrect, the paddles did not work and the plug malfunctioned. Carvelot was eventually resuscitated; however, the defibrillator never did work.  

Carvelot alleges that, as a result of being deprived of oxygen to the brain, he has suffered problems with his memory, can no longer drive since he lost peripheral vision, has problems with anger and suffers from depression. He and his wife, who is also is seeking damages for the loss of her husband’s affection, companionship and services, are seeking compensation in excess of $250,000.

An Illinois heart surgeon, who encountered a malfunctioning defibrillator during an emergency coronary artery bypass operation, advised the patient’s family to “see an attorney” following the surgery at Belleville Memorial Hospital in Belleville, Illinois on November 11, 2003.

The patient, William Carvelot, who survived the surgery but who allegedly suffered neurological problems as a result of oxygen deprivation, took his doctor’s advice and sued both the hospital and the doctor himself.
According to the complaint, Dr. Bill Daily performed the emergency coronary artery bypass when Carvelot went into ventricular fibrillation and had difficulty breathing. CPR was initiated and lasted more than 15 minutes.

During that time, defibrillation was attempted but the machine did not work. The complaint claims that the machine was not programmed properly: its synch mode was incorrect, the paddles did not work and the plug malfunctioned. Carvelot was eventually resuscitated; however, the defibrillator never did work.  

Carvelot alleges that, as a result of being deprived of oxygen to the brain, he has suffered problems with his memory, can no longer drive since he lost peripheral vision, has problems with anger and suffers from depression. He and his wife, who is also is seeking damages for the loss of her husband’s affection, companionship and services, are seeking compensation in excess of $250,000.