January 14th, 2011 by admin in Health Tips, News, Video
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This is a guest post from Dr. Mary Lynn McPherson.
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FDA Restricts Acetaminophen In Popular Pain Medications
The Food and Drug Administration (FDA) made an announcement yesterday that affects one of the most common pain medications on the market, and as a consequence may affect countless numbers of the 75 million Americans who experience chronic pain (for perspective, that’s more than the number of people suffering from cancer, heart disease and diabetes combined.) The FDA has asked manufacturers of popular prescription pain medications like Vicodin or Percocet to limit the amount of acetaminophen (also known as Tylenol, or APAP) used in these drugs to no more than 325 milligrams per tablet — the equivalent of one regular-strength Tylenol tablet.
The move came because research has shown that acetaminophen can cause liver damage when taken in higher than recommended doses. The problem is that many over-the-counter medications ALSO contain acetaminophen, and patients may take one or more of these common products (like Tylenol) to reduce their fever or get rid of a headache along with their prescription pain relievers.
Before you know it, you could be taking more than the maximum daily dose of acetaminophen which is 4,000 milligrams. I go out of my way to advise people I work with of this warning, but not everyone takes time to talk to the pharmacist and not all pharmacists make themselves readily available. That is why it is critically important that you talk to your pharmacist to make sure that you are not taking more than this amount. The pharmacist is the last stop between you and medication misuse — you could be taking a medication that contains acetaminophen and not even know it. Read more »
January 7th, 2011 by Peggy Polaneczky, M.D. in Better Health Network, Health Tips
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Cute packaging and product placement in the checkout lane at Duane Reade will get you generic Tylenol for a price equivalent to $50 for 100 tabs, as opposed to $6 per 100 count in the usual package.
*This blog post was originally published at tbtam*
December 15th, 2010 by admin in Health Tips
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This is a guest post from Dr. Mary Lynn McPherson.
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Rescuing Patients On Darvon Or Darvocet With Zero Tolerance For Pain
On November 19, 2010 the Food and Drug Administration (FDA) called for a halt in the use of the popular opioid pain relievers Darvocet and Darvon. These products contain the opioid propoxyphene, and it has been used to treat mild to moderate pain for over 50 years. However, concerns have long been raised about the effectiveness of this drug, and the risk of death (accidental and suicide). Darvon and Darvocet were banned in Britain in 2005, followed by the European Union in 2009. Over the past 30 years, the FDA has received numerous petitions to take these drugs off the U.S. market.
Research has shown that Darvon and Darvocet are no more effective for treating moderate pain than over the counter drugs like acetaminophen, aspirin or ibuprofen. Unfortunately, Darvon and Darvocet cause a lot more side effects such as dizziness, drowsiness, nausea and vomiting, hallucinations and constipation (all pretty typical of opioids used to treat pain). But, the side effects don’t stop there. The data is in, and it’s not a pretty picture. A recent study requested by the FDA showed that when used at the recommended doses, Darvon and Darvocet cause significant changes in the electrical activity of the heart, which can lead to a fatal irregularity in your heartbeat, even after only short-term use.
Among those advocating for the removal of these drugs from the market were pharmacists. The American Society of Health-System Pharmacists approved a policy in 2007 advocating for the withdrawal of Darvon and Darvocet from the U.S. market, and recently testified at the FDA Advisory Committee to this effect. As an often overlooked member of the medical team, pharmacists have a vital role to play in providing safe and effective treatments. We serve as the last line of defense against improper or unwise prescribing of drugs — especially those for pain. We are drug experts, and we can help patients and doctors switch from Darvon or Darvocet to safer and more effective treatments. Read more »
July 9th, 2009 by DrRob in Better Health Network, True Stories
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My worst night as a doctor was during my residency. I was working the pediatric ICU and admitted a young teenager who had tried to kill herself. Well, she didn’t really try to kill herself; she took a handful of Tylenol (acetaminophen) because some other girls had teased her.
On that night I watched as she went from a frightened girl who carried on a conversation, through agitation and into coma, and finally to death by morning. We did everything we could to keep her alive, but without a liver there is no chance of survival.
Over ten years later, I was called to the emergency room for a girl who was nauseated and a little confused, with elevated liver tests. I told the ER doctor to check an acetaminophen level and, sadly, it was elevated. She too had taken a handful of acetaminophen at an earlier time. She too was lucid and scared at the start of the evening. The last I saw of her was on the next day before she was sent to a specialty hospital for a liver transplant. I got the call later that next day with the bad news: she died.
The saddest thing about both of these kids is that they both thought they were safe. The handful of pills was a gesture, not meant to harm themselves. They were like most people; they didn’t know that this medication that is ubiquitous and reportedly safe can be so deadly. But when they finally learned this, it was too late. They are both dead. Suicides? Technically, but not in reality.
For these children the problem was that symptoms of toxicity may not show up until it is too late. People often get nausea and vomiting with acute overdose, but if the treatment isn’t initiated within 8-10 hours, the risk of going to liver failure is high. Once enough time passes, it is rare that the person can be cured without liver transplant.
Acetaminophen overdose is the #1 cause of liver failure in the US. According to a Reuters article, there are 1600 cases of liver failure from this drug per year (2007). This is a huge number. In comparison consider that the cholesterol drug Cerivastatin (Baycol) was withdrawn from the market when there were 31 deaths from rhabdomyalysis (severe muscle break-down, which is far more common than liver failure in these drugs). These happened mainly when the drug was used in combination with another cholesterol drug.
Should the drug be pulled from the market? No, it is safe when used properly. The toxic dose is generally 10 times the therapeutic dose. My complaint is not that they have dangerous drugs available; ALL drugs should be considered dangerous. Aspirin, decongestants, anti-inflammatories, and even antacids can be toxic if taken in high dose. The problems with acetaminophen stem from several factors:
- Most people don’t realize the danger.
- There has been very little public education and no significant warning labels on the packages.
- The drug is often hidden in combination with other drugs, including prescription narcotics and over-the-counter cold medications. This means that a person can take excess medication without knowing it.
I would advocate putting warning labels on medications containing this drug. I am sure this doesn’t thrill the drug manufacturers, but the goal is not to make them happy. I have thought this since that terrible night during residency. If there was such a warning, perhaps she wouldn’t have died.
It seems a bit silly that this action by the FDA is coming after their pulling of children’s cough/cold medications. Those drugs have very small numbers of true harmful overdoses. The reason they were pulled was probably more that they didn’t do anything over the fact that they were dangerous. Acetaminophen, on the other hand, can be deadly.
Just ask the parents of my two patients.
*This blog post was originally published at Musings of a Distractible Mind*
