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Illinois (U.S.) Law Will Now Require Hospitals to Report 24 Types of Medical Errors

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."

Study Finds Job-Related Exposure to Pesticide (Diazinon) May Increase Cancer Risk

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.

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

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.”

Mixing Up Drugs with Similar Names Can Cause Potentially Deadly Medication Errors

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.

Many People Ignorant of the Potential Side-Effects of Painkillers

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.

After Hospital Defibrillator Fails to Work, Heart Surgeon Advises Patient's Family to 'See an Attorney'

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.

Possible Link between Abortion Pill and Multiple Deaths from Same Deadly Bacteria to Be Probed by FDA and CDC

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.

CPSC and Delta Enterprise Corp. Announce Recall of Certain Cribs Sold at Toys R Us Stores for High Levels of Lead Paint

The Consumer Product Safety Commission, in cooperation with Delta Enterprise Corp., of New York, N.Y., has announced a voluntary recall of about 335 Lov’s “Europa” Natural Color Cribs manufactured in Indonesia by Delta Enterprise Corp. of New York, N.Y. Consumers should stop using recalled products immediately.

The cribs paint contains high levels of lead. Lead poisoning in children is associated with behavioral problems, learning disabilities, hearing problems and growth retardation. No incidents or injuries have been reported.
The cribs are made of wood and are natural color. Only cribs that are labeled Lov’s Europa with “Style # 4827-2 M.F.G. No.: W 24088 Date: 22 JUN 2004” are included in the recall. The brand, style and date code are printed on a label attached to the mattress support platform.

The cribs were sold exclusively at Toys R Us nationwide from July 2004 through August 2005 for about $200.
Consumers should stop using the recalled crib immediately and return to retailer where purchased for a credit or refund. 

For additional information, contact Delta Enterprise Corp. toll-free at (877) 660-3777 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.deltaenterprise.com

Ortho Evra Warning Already Causing Doctors to Abandon the Patch in Favor of Safer Alternatives for Their Patients

The Wall Street Journal (WSJ) is reporting that: “Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it.”

(http://online.wsj.com/article/0,,SB113262165542103693,00.html?mod=djemHL)

According to the WSJ: “[A] number of individual practitioners and major health-care providers say they don’t want to take any chances. In Memphis, Tenn., obstetrician and gynecologist Henry Sullivant says he has stopped writing new patch prescriptions and suggests that his roughly two dozen patch users try other forms of prescription contraceptives, such as the pill or a monthly vaginal ring. Pennsylvania State University, which provides health services for 42,000 students, is no longer issuing prescriptions and says it is considering whether to contact all students who have been given prescriptions for Ortho Evra, even if they are no longer at the university.”

In a effort to exercise caution, similar actions are being taken by many other university health officials including those at the University of Texas at Austin, Stanford University, the University of California, Berkeley, and Connecticut College in New London, Connecticut where one patch user experienced a blood clot in her lung last spring.

In addition “Lee Shulman, incoming board chairman of the Association of Reproductive Health Professionals, says he expects that ‘there will be a decrease in use’ of Ortho Evra, at least over the next several months. He adds that he has been inundated with doctor and patient phone calls asking whether the patch is safe to use.”

When asked for his thoughts on the matter, Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation, told us that: “This is a particularly dangerous situation for doctors and major healthcare providers like colleges and universities since the warning involved ere is quite strong and very specific. The danger posed by the patch is a very real one and it’s not a secret anymore.”

Mr. Parker continued: “There are also many well-publicized law suits out there alleging deaths and catastrophic injuries from the very side-effects contained in the new warning.

Thus, any doctor writing a prescription for the patch from this point on is doing so at his or her peril. Given the potentially fatal side-effects of the drug, writing a prescription now could be considered irresponsible in terms of good and accepted medical practice especially if an otherwise healthy woman is paralyzed or dies from a stroke caused by blood clots after using the patch.”

Parker sees this as “a malpractice case just waiting to happen. It’s no wonder so many healthcare providers are rethinking their policies and recommending alternative medications to their patients. Their caution is well-advised at this point.”

Only last week, another high-profile wrongful death case was commenced against Ortho-McNeil and Johnson & Johnson. It involves Alycia Brown, an eighth-grader in La Crosse, Wisconsin, who died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.

The federal law suit filed in Madison by her parents claims the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.

Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14-year-old is now the youngest known victim.

The girl’s mother had feared that her daughter was having sexual relations. The patch was decided upon because the girl was afraid to have a birth control shot because she was afraid of needles. The mother wanted to avoid the possibility of Alycia ruining her life with an unwanted teenage pregnancy. What happened, however, was far worse.
Ortho-McNeil has finally acknowledged the fact that women who use its Ortho Evra birth control patch are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.

The company now admits that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch. Two weeks ago, CBS News presented a story concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.

According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.

In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.

Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.

An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request. In an Associated Press follow-up story, the AP stated:

“Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA’s death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).

In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.

Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.

The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.

Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.
The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at:

http://www.fda.gov/cder/foi/nda/2001/021-180_ORTHO.htm

Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].

The FDA medical officer also included the following statement in his comments:

The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”

In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing or than 198 pounds (90 kilograms).

Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.

Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).

There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”

As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.”

The Ortho-McNeil’s Press Release is a rather difficult document for the average person to understand. If its implications are considered with respect to the amount of estrogen that can be released in a given period of time, however, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.

A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the Patch over nine months ago in the journal Contraception.
In addition to the risks already discussed, cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including ORTHO EVRA, should not smoke.

The mounting litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.

A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.

The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25 year old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.

Before the Alycia Brown case was filed, the youngest woman to die had been an 18 year old college student who collapsed in the New York subway. Many other women ranging in age from 18 to 27 have also sued Ortho-McNeil.

In September, Parker & Waichman, a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey.

According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch, according to the suit.

This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.
As Lorie Brown, Alycia’s grieving mother, told reporters last week: “I’m out to let people know: get off (Ortho Evra). That’s my biggest goal here. I didn’t save her life, but maybe I can save somebody else’s.” It seems that many responsible doctors and major healthcare providers are trying to do the very thing.

Researchers Find Antibiotic Use in Childhood or Heavy NSAID Use May Increase Risk of Lymphoma

A study conducted at the Northern California Cancer Centre in Fremont and published in the most recent issue of the American Journal of Epidemiology found that using antibiotics more than 10 times in childhood or being a “heavy” user of non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing non-Hodgkin’s lymphoma (NHL).

Prior studies to determine if there is any association between the use of certain medications and the  increase in NHL cases have proven to be inconclusive except with respect to powerful immunosuppressive drugs. Since many medical conditions themselves are linked to NHL, it was also difficult to determine if those conditions or the medications used to treat them were associated with the NHL.

The current study used data from the Scandinavian Lymphoma Etiology Study, which involved 3,055 NHL patients as well as the records of 3,187 healthy subjects from Denmark and Sweden.

While there was a “striking” association between antibiotic use and NHL for all subtypes of the disease, heavy NSAID use increased the overall risk of NHL and of diffuse large B-cell NHL and not any other type of NHL.

If the link between antibiotic use and NHL is borne out by further studies, the significant increase in the use of antibiotics could offer an explanation for the increase in NHL cases.

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