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FDA Restricts Acetaminophen In Popular Pain Medications

This is a guest post from Dr. Mary Lynn McPherson.


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 »

Pain Contracts: Do They Threaten The Doctor-Patient Relationship?

Doctors today are wary about treating chronic pain. One of the main worries is precipitating fatal opioid overdoses. Indeed, according to the CDC, and reported by American Medical News, “fatal opioid overdoses tripled to nearly 14,000 from 1999 to 2006 … [and] emergency department visits involving opioids more than doubled to nearly 306,000 between 2004 and 2008.”

Requiring chronic pain patients to sign pain contracts is a way to mitigate this risk. But how does that affect the doctor-patient relationship?

Indeed, a contract is an adversarial tool. Essentially, it states that a patient must comply with a strict set of rules in order to receive medications, including where and how often they obtain controlled substances, and may involve random drug testing. Break the contract and the patient is often fired from the practice. Read more »

*This blog post was originally published at*

Painkiller Safety

Perhaps as many as one in every five American adults will get a prescription for a painkiller this year, and many more will buy over-the-counter medicines without a prescription. These drugs can do wonders — getting rid of pain can seem like a miracle — but sometimes there’s a high price to be paid.

Remember the heavily marketed COX-2 inhibitors? Rofecoxib, sold as Vioxx, and valdecoxib, sold as Bextra, were taken off the market in 2004 and 2005, respectively, after studies linked them to an increased risk of heart attack and stroke.

The nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin, ibuprofen (sold as Advil and Motrin), and naproxen (sold as Aleve) seem like safe bets. But taken over long periods, they have potentially dangerous gastrointestinal side effects, including ulcers and bleeding. Kidney and liver damage are possible, too. More recently, some of the NSAIDs have been linked to an increased risk of cardiovascular disease. Low doses of aspirin (usually defined as 81 mg) is an exception and is often prescribed to lower the risk of heart and stroke.

Even acetaminophen, which is often viewed as the safest pain drug and a low-risk alternative to the NSAIDs because it doesn’t have their gastrointestinal side effects, comes with a caution about high doses possibly causing liver failure. Read more »

*This blog post was originally published at Harvard Health Blog*

Your Pharmacist’s Role In Safe, Effective Prescription Drug Treatment

This is a guest post from Dr. Mary Lynn McPherson.


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 »

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