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While most of the attention about the dangers of pharmaceutical products is focused on prescription drugs, an even more deadly problem may exist in a far more common group of products: over-the-counter medications
In fact, according to the American Academy of Family Physicians, 60% of all drugs sold in the United States are over-the-counter (OTC). Indeed, there are currently 700 different OTC medicines on the market today – many at doses that were only available by prescription just three decades ago. They are used to treat more than 400 illnesses.
They are also a cash cow for Big Pharma. Today, OTC drugs are a $26 billion industry, and are growing every year.
Most people assume that the OTC products like Tylenol or Aleve in their medicine chests are safe. After all, if they weren’t wouldn’t they be available by prescription only?
That might seem to make sense, but nothing could be further from the truth!
What few of their users realize is that the OTC products they use so routinely often hold the potential for deadly side effects.
What few of their users realize is that the OTC products they use so routinely often hold the potential for deadly side effects.
This is particularly true of OTC painkillers, and yet the public remains largely indifferent to the risk.
This is no small problem. Over 175 million Americans take OTC painkillers on a regular basis.
And they clearly believe that what they are taking is safe.
Indeed, a survey of 4,200 adults conducted by the National Consumer’s League last October showed a disturbing lack of concern about of the dangers of OTC medicines among the general public.
According to the survey, around 84% of Americans had taken over-the-counter pain relievers during the previous year. Of that group, however, fully half admitted that they had exceeded the recommended dose. Indeed, many admitted that they had read the label, but ignored the warnings!
Some 45% of those surveyed also said that it was OK to take an over-the-counter pain reliever along with another cold or flu medication. What many did not realize, however, was that most cold and flu medicines sold over-the-counter also contain nonprescription pain relievers making an overdose likely.
An astounding 20% believed that it was OK to drink while taking OTC pain killers.
An identical percentage did not know that the medicines could cause serious side effects including stomach bleeding, kidney damage and liver problems!
Only 5% bothered to discuss the potential risks with their doctors and 30% said they usually didn’t bother to read the label instructions. Another 25% said they had trouble reading or understanding the label.
But how much of a threat could OTC drugs pose?
As it turns out, the threat is quite a substantial one.
Just consider this: 160,000 people are admitted to hospital emergency rooms for overdoses of OTC painkillers each year, and 17,000 die from OTC painkiller overdoses annually.
To put these figures in perspective, you are 2.8 times as likely to be hospitalized due to an overdose of an OTC painkiller as you are to be in an automobile accident!
What’s worse, you may not even know you are exceeding the recommended dose, especially when it comes to Tylenol.
Surprising as it may seem, Tylenol is the leading cause of death from drug overdose in the United States, ranking ahead of Cocaine, Prescription Narcotics, Calcium Channel Blockers, Antidepressants, Benzodiazepines (such as Valium) and Aspirin.
A TRAGIC AND AVOIDABLE DEATH
The story of Marcus Trunk demonstrates just how easy mistakenly taking an overdose can be.
Marcus Trunk was a young man with a bright future. At 23, he had his own contracting business and by all accounts was headed for success. Then, in April of 1995, he badly sprained his wrist while working on a job. He visited his doctor and was given a prescription for 10 days worth of Tylenol 3 – Tylenol with codeine. When his wrist was still bothering him after the prescription ran out, he purchased a bottle of regular strength Tylenol over the counter and took the recommended dose for an additional week.
At no time did Marcus exceed the recommended dose, and since he did not drink, there was no possibility that he had taken Tylenol and alcohol – a potentially deadly mixture.
After a few days, Marcus began to experience flu-like symptoms, and purchased an OTC product, Theraflu to combat them. He also continued to take Tylenol.
What Marcus did not realize was that the four packets of Theraflu the package indicated he should take daily each contained 1000 mg of Tylenol. That meant that in following the package instructions, he was already getting the maximum recommended dose of the OTC painkiller, so in taking regular strength Tylenol along with it, he was inadvertently overdosing.
When the symptoms not only persisted, but seemed to worsen, his worried parents who live in Florida, had a relative take him to the local emergency room, After examining him, the doctors gave him – you guessed it – Tylenol.
When the tests taken in the emergency room came back, the doctors were alarmed. The liver function tests were abnormal, so his doctor asked him a series of questions trying to determine the cause.
They asked about his drug use. He didn’t use drugs.
They asked about his alcohol use. He didn’t drink.
They asked about his sexual history. He did not engage in high-risk behavior.
What they didn’t ask was how much Tylenol he had taken.
As Marcus got worse and worse, he was transferred to another hospital and was soon on life support and at the top of the liver transplant list.
But it was too late.
A liver could not be found in time.
After a week, his family had to make the painful decision to remove him from life support. Moments later, Marcus died.
For his mother, the shock was almost too much to bear. “He was a perfectly healthy 23-year-old man. … We just couldn’t believe it.”
Even harder to accept was what they learned after an autopsy was performed.
The autopsy showed that the cause of death was acute acetaminophen poisoning – a Tylenol overdose.
Worse, had he been given an antidote within 72 hours of the initial diagnosis, Marcus would still be alive!
Yet not one of the doctors bothered to ask how much Tylenol he had taken. Indeed, they even gave him more worsening his condition!
The possibility simply never occurred to them, even though Tylenol overdose is the leading cause of drug-related deaths and account for at least 56,000 emergency room visits annually!
Moreover, the danger of inadvertently overdosing is far greater than most people realize. There are over 200 OTC products that contain acetaminophen. Indeed, almost any product that is designated “multi-symptom” or “non-aspirin” is likely to contain Tylenol!
Moreover, since the early symptoms of Tylenol overdose, nausea, vomiting, malaise and pain in the right chest mimic those of the flu, like Marcus, many people assume that is what they have and take Tylenol laced flu medications making the problem worse. Even in the later stages when the patient is jaundiced, doctors frequently misdiagnose Tylenol overdose as hepatitis, losing the opportunity to administer an antidote during the critical 72 hour period.
But as dangerous as Tylenol is for adults, it is even more dangerous for children.
TYLENOL AND CHILDREN
When Tylenol first came on the market, pediatricians saw it as a godsend. Research had shown that aspirin was linked to Reye’s syndrome, an inflammation of the brain associated with damage to the liver. It typically occurs in conjunction with a viral infection such as the flu or chicken pox and can result many of the body’s organs failing so that life support is required. Given the danger, Tylenol was welcomed as a safe alternative.
But safe is a relative term.
Many drugs are safe when used appropriately, but pose grave dangers when they are not, and Tylenol is one of them.
Over 27,000 accidental Tylenol overdoses in children are reported annually.
For example, in 1989, just after Christmas Lacy Keele a five-year-old in Louisiana came down with the flu. As would be expected – and as virtually every pediatrician recommends – she was given Tylenol for the accompanying fever and aches. The only trouble was that Lacy’s parents didn’t understand the difference between the adult and children’s strength versions of the medication. Besides, it was what pediatricians recommend. What they did not realize that in giving their child four extra strength Tylenol tablets in a single day, they had given Lacy twice the amount of the medicine recommended for a child her size and age. Her liver was destroyed and a week later she was dead.
Or take the case of Sophie Regosin-Hodges, a 14 month-old infant who was given a near-fatal dose of children’s Tylenol due to a mix up on the part of her pediatrician about the appropriate dosage. Her mother had given her Tylenol infant drops, but the pediatrician mistakenly used the dosage for Tylenol children’s suspension in his instructions. Tylenol infant drops are three times as potent as the children’s suspension. The packages for the two products, however, were virtually identical leading to the confusion. Sophie survived the overdose, but only because of a transplant of liver tissue from her father. As a result, she will be on immunosuppressant drugs for the rest of her life.
Since Sophie’s case, Tylenol’s manufacturer, Johnson & Johnson has changed the packaging, but that is little solace to her parents. Nor is the fact that dosage errors can still easily occur with the infant drops.
One inherent problem is that the instructions are to administer one eye-dropper full of the medicine. The only trouble is that parents can become confused as to what actually constitutes an “eye-dropper full.” What the company means is to fill the eye-dropper provided to a line marked on the barrel. With very small infants, even a small deviation from this measurement can have dangerous consequences.
What is perhaps most disturbing about Tylenol, though, is the reluctance of Johnson & Johnson to move aggressively to warn users about potential dangers.
HIDING THE FACTS
In 1993, Mary Rose Palmison, a moderate drinker who regularly took Tylenol for back pain checked into a hospital suffering from nausea. A month later she was dead. The cause: Tylenol toxicity had poisoned her liver.
In February of 1993, Antonio Benedi, a White House aide, was admitted to the hospital with signs of liver failure. His doctors told him he might not make it through the night. But luck was on his side. A donor was found and a liver transplant saved his life. Still, that was just the beginning of his medical nightmare. The illness had also damaged his kidneys, and eventually he had to undergo a kidney transplant as well.
While the sudden illness came as a shock to Benedi, what came as even more of a shock was the cause: Tylenol.
What Benedi did not know was that his practice of having a glass or two of wine with dinner had placed his life in jeopardy. What he was not told was that even taking the recommended dose of Tylenol could be deadly because of his moderate drinking. What he was not told was that Johnson & Johnson had been aware of this potential problem since 1977, fully TWENTY-SEVEN YEARS prior to his overdose, but had neglected to include a warning on the product label.
Benedi had fallen victim to what doctors call “alcohol-acetaminophen syndrome.” In plain English, what this refers to is the fact that drinking even small amounts of alcohol can affect the toxicity of acetaminophen (the therapeutic ingredient in Tylenol).
The source of the problem is the fact that when you drink alcohol, it takes up to five days for it to be completely cleared from the liver. So if you are a light to moderate drinker – one to two drinks a day – you are going to have a moderate amount of alcohol in your liver at any given moment.
When you then take an acetaminophen-based medicine such as Tylenol, about 5% of it is converted into a highly toxic compound called N-acetyl-para-benzo-quinoneimine. Normally, the chemical is neutralized in the liver by glutathione. The trouble is that when you have consumed alcohol, both the drug and the alcohol are trying to be metabolized at the same time. But the alcohol always wins, so the level of N-acetyl-para-benzo-quinoneimine in your liver quickly builds up and overwhelms the ability of the glutathione produced to neutralize it. Eventually it reaches toxic levels.
What is particularly disturbing is that cases of alcohol-acetaminophen syndrome have been documented in people taking as little as 4 grams of Tylenol per day, the equivalent of taking two, 500 mg tablets in a 24 hour period.
This also happens to be the recommended dose!
But if alcohol can pose such a danger when taken with Tylenol even at recommended levels, why did it take TWENTY-SEVEN YEARS to put a warning on the label? The answer is simple: greed.
Tylenol is a cash cow for Johnson & Johnson. Even though generic versions are available at a fraction of the cost, it still commands 30% of the cold, headache and fever market and rakes in $1.3 billion a year. This is largely the product of massive expenditures on advertising – over $250 million a year. To put the figure in perspective, Johnson & Johnson spends more to promote Tylenol than the Coca Cola Company spends to promote Coke!
Moreover, since the active ingredient, acetaminophen has been around for a century and therefore required no investment in research, the profit margins are enormous.
But it’s not just in combination with alcohol that Tylenol poses a danger.
The same 1977 FDA Advisory Panel that warned about the dangers of taking acetaminophen products and alcohol also warned that taking even the maximum “safe” dose for an extended period posed significant risks.
The extent of the risk was made clear in a study by Dr. William Lee of Texas Southwestern Medical Center in Dallas, Texas.
Dr. Lee reviewed more than 300 acute liver failure cases at 22 hospitals in Texas. He found that 38% of the cases were linked to acetaminophen. He also reviewed another 307 cases of adults who suffered severe liver injury – not complete failure – at six Texas hospitals. He found that among those patients, 35% of the cases were linked to acetaminophen! A third study by Dr. Lee reviewed 71 cases of acetaminophen poisoning at Parkland Memorial Hospital in Dallas, Texas. The patients included 50 who had attempted suicide and 21 who were accidental overdoses. Among them 10 suffered acute liver failure, five died and 66 required hospital stays of up to 51 days.
What is particularly disturbing is the fact that 7 of the 10 who suffered acute liver failure were among those who had ingested accidental overdoses, even though they only constituted around 30% of the total number of admissions. Similarly, 4 of the 5 patients who died were among the accidental overdose group.
Dr. Lee said the reason overdoses appeared so common was that people think that since acetaminophen is sold over-the-counter “… it must be safe and they take it like M&Ms.”
What they don’t realize is that acetaminophen overdoses could be an even greater cause of liver failure than drugs such as Rezulin that were withdrawn from the market.
But it’s not just the acetaminophen in your medicine chest that poses a danger.
OTHER MEDICINE CHEST DANGERS
ASPIRIN
Virtually every American household has a bottle of aspirin in its medicine chest.
As early as the 5th Century B.C., it was known that extracts of willow bark could relieve pain and fevers. In the mid-19th Century, chemists in France were able to isolate Salicylic Acid, from meadowsweet flowers. While it was somewhat effective, it also had serious side effects on the gastrointestinal tract. But in 1897, Felix Hoffman, a chemist working for the German chemical firm Friedrich Bayer & Co. was able to isolate the acetyl group of Salicylic Acid. Bayer gave the new compound, Acetyl-Salicylic-Acid the trade name Aspirin. It was the first purely synthetic drug and gave birth to the pharmaceutical industry.
For more than 100 years, Hoffman’s discovery has been one of the most versatile and widely used drugs ever invented. Even today, it seems that more and more uses for this genuine wonder drug are being discovered. The trouble is that some of the recommended uses may pose more problems than solutions.
AN ASPIRIN A DAY?
One of the most widely touted “new” uses for aspirin is in the prevention of heart attacks. Indeed, it has now become axiomatic for physicians to recommend that their patients take an aspirin a day – even where no evidence of cardiac risk exists. In large part this is because the doctors assume that aspirin is “safe” and so they take the attitude that it won’t hurt and might help – so why not recommend aspirin therapy.
The trouble is they couldn’t be more wrong!
The recommendation that patients take aspirin to prevent heart attacks is actually the product of one limited study conducted in 1988. The researchers had examined a small group of men who were high-risk candidates for heart attacks. They found that daily doses of aspirin cut the risk of heart attack in half.
But that wasn’t their only conclusion.
They also discovered that the daily aspirin dose dramatically increased the incidence of strokes! As a result, they recommended AGAINST giving patients aspirin to prevent heart disease!
Their warning, however, didn’t stop Big Pharma.
Literally the day after the report was published aspirin makers put out a deluge of press releases touting “an aspirin a day” as the way to prevent heart attacks. No mention was made of the increased risk of stroke.
As the relentless PR campaign continued, the notion that taking an aspirin a day was beneficial worked its way into the conventional wisdom. Over time, doctors came to accept it as axiomatic, without taking the time to actually review the literature. Had they done so, they would have been surprised.
A study by Dr. Jiang He of Tulane University reviewed 16 controlled trials of preventative aspirin to estimate the risk of hemorrhagic stroke associated with aspirin. What they found was frightening. While their research showed that daily aspirin lowered the risk of heart attack by 32%, it INCREASED the risk of brain hemorrhages by 84%!
But that’s not all the bad news about aspirin.
OTHER ASPIRIN DANGERS
In October of 2003, a study was presented at the 69th Annual Convention of the American College of Chest Physicians in Orlando, Florida that found that when patients were taken off daily doses of aspirin, they suffered a form of withdrawal that caused blood clots that could cause heart attacks and strokes! Moreover, the clots could crop up as soon as one week after aspirin therapy was stopped! As a result, the authors recommended that once an individual was put on a daily aspirin regimen they remain on it for the rest of their lives.
Another study of 90,000 nurses conducted over an eighteen-year period revealed yet another danger. In that study a connection was found between aspirin use and pancreatic cancer! The study found that individuals who took at least two aspirins a day for a period of at least four years had an 86% increased risk of the disease. The study’s authors had concluded that the regular aspirin use might have caused pancreatitis in the nurses eventually leading to the pancreatic cancer.
Yet a third study conducted at King’s College Hospital in London and Royal Prince Alfred Hospital in Sydney, Australia analyzed 21 previous studies linking aspirin to asthma attacks. The scientists concluded that one in five asthma sufferers risk a life-threatening reaction to aspirin. Scientists had long been aware of the connection, but there was little understanding of how widespread aspirin sensitivity was among asthma sufferers. Most disturbing was the fact that most aspirin-sensitive asthmatics were also sensitive to other OTC pain relievers.
IBUPROFEN AND NAPROXEN
Two other common OTC pain relievers Ibuprofen (Advil, Motrin) and Naproxen (Aleve) also may pose unanticipated dangers.
In December of 2004 the Food and Drug Administration halted a clinical trial attempting to determine if Naproxen or other NSAIDS might help prevent Alzheimer’s disease when it was discovered that patients taking Naproxen had a 50% increase in their risk for heart attacks. This was the most recent in a series of reports that show NSAIDS increased heart risk. But it is not the only danger Naproxen holds.
Adverse effects linked to Naproxen range from relatively minor ones like headache, dizziness and stomach pain to much more serious ones such as gastrointestinal bleeding, kidney failure and liver failure. Like Tylenol, the combination of Naproxen and alcohol can prove fatal. Also, like virtually all OTC pain relievers, Naproxen greatly increases the action of blood thinners such as Coumadin, raising a serious danger of internal bleeding, including brain hemorrhages.
A second major concern with Naproxen is that when taken for an extended period of time, the prospect of major adverse effects increases, especially liver and kidney damage.
Ibuprofen (Advil), another widely used pain reliever shares many of the same concerns as Naproxen. As with Naproxen, Ibuprofen increases the risk of gastrointestinal bleeding and hemorrhage – especially if taken along with blood thinners like Coumadin.
A unique concern with Ibuprofen is the number of drugs interactions it can cause. For example, laboratory studies show that it substantially increases the toxicity of Methotrexate. It also reduces the effect of anti-hypertension diuretics such as Thiazide. Patients taking Lithium should avoid Ibuprofen because it prevents the body from clearing it leading to potentially fatal Lithium Toxicity.
Finally, as with Tylenol and Naproxen, Ibuprofen interacts with alcohol to create toxic products in the liver. You should NEVER take any OTC pain reliever if you have been drinking alcohol. Also, remember that it takes FIVE DAYS for alcohol to clear your liver, so even if you did not take a drink on the day you took the pain reliever, you still could be at risk!
THE BOTTOM LINE: ALL DRUGS POSE DANGERS
The most important thing to keep in mind about OTC products is that THEY ARE DRUGS! The fact that they are available over-the-counter does not mean that they are safe – it just means that they are easier to get! Also, many of today’s OTC drugs like Advil, Naproxen and others were only available on a prescription basis until recently. This is not to say that they have no purpose or value, but rather that like any other drug, they should be used with caution.
You have to be an educated consumer. You have to read the label and you have to educate yourself. Sadly, most doctors are even less aware of the potential side effects of OTC drugs than they are about the side effects of prescription medications. So take the time to look up the potential side effects and drug interactions of the OTC medications you take. The life you save may be your own.
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