It has been a tough few months for pain medications—both prescription and over the counter. In late June, a Food and Drug Administration advisory panel recommended lowering the maximum daily dose of acetaminophen, the ingredient found in Tylenol and many other over-the-counter and prescription medications, because liver damage can occur if people take too much of it. And earlier this month, the FDA ordered manufacturers of pain medications containing an ingredient called propoxyphene to strengthen the drug labels, including a boxed warning that emphasizes the potential for overdose in people taking these pain medications, which include the older pain drugs Darvon and Darvocet.
This news has left some consumers scratching their heads about which pain medications to take, doctors say. "The key thing is that the public has been getting very, very mixed messages" about painkillers lately, says Scott Fishman, past president of the American Academy of Pain Medicine and president of the American Pain Foundation, a patient organization. According to several experts, here's what consumers need to know about these pain medications:
* The commonly used propoxyphene-containing medications Darvon (propoxyphene) and Darvocet (a combination of propoxyphene and acetaminophen) are typically used to treat "mild-to-moderate, usually acute pain," says Paul Christo, director of the multidisciplinary pain fellowship program at the Johns Hopkins University School of Medicine. A primary reason for concern with these medications stems from a possible increased risk of fatal overdose, according to the FDA. There is evidence of both accidental and intentional fatal overdoses from propoxyphene, and some European research suggests that this drug may be more deadly when too much is taken than other types of pain medications. There are also "fairly high quality studies that demonstrate that propoxyphene is no more effective than aspirin or acetaminophen," Christo says.
Despite these concerns, the FDA recently denied a citizen's petition from Public Citizen, a consumer advocacy organization (and went against its own advisory panel's 14-to-12 vote), in favor of a phased withdrawal of propoxyphene from the market. The agency says that there is evidence that the drug effectively treats pain when taken at recommended doses. Some doctors say they are glad that the FDA has not withdrawn propoxyphene, because that means people in pain have more options for treatment. "One of the controversies is you don't want to take away options for people who can't tolerate Vicodin or other stronger medications," says Rollin Gallagher, president of the American Academy of Pain Medicine and clinical professor of psychiatry and anesthesiology in pain medicine at the University of Pennsylvania. The key here, he says, is to spend time with your doctors asking questions, writing things down, and really understanding how to properly take medications.
In addition to requiring a beefed-up label for these medications—which the manufacturers must submit within 30 days of the July 7 announcement (or state why they don't think labeling changes are necessary)—the FDA is ordering a new study to look into how propoxyphene affects the heart at higher-than-recommended dosages. The agency says that this could lead to regulatory action, depending on the findings. "The issue is that, in rare cases, it can affect the heart rhythm in a deadly way," Fishman says. The FDA says it intends to collaborate with the Centers for Medicare and Medicaid Services and the Veterans Health Administration to study how often elderly people take propoxyphene instead of other types of pain medications and the difference in safety between these medications and other pain medications.
Cynthia Reilly, director of the practice development division at the American Society of Health-System Pharmacists, says the organization was disappointed that the FDA did not pull propoxyphene from the market. "We testified, calling for market withdrawal [because of] safety concerns with propoxyphene," she says. "Considering the number of other options, and considering the safety and effectiveness concerns, we would've hoped that it would've been withdrawn from the market."
In prepared written testimony for a statement given before the FDA in January, Reilly cited research that she says demonstrates that propoxyphene has a poor record of effectiveness. Among the research she cited was a meta-analysis of 26 studies involving 2,231 patients who had postoperative, arthritis, or musculoskeletal pain that compared the effectiveness of acetaminophen plus propoxyphene and the effectiveness of acetaminophen taken alone or with a placebo. The findings showed that adding propoxyphene was no more effective than taking acetaminophen alone. Another study she cited involved patients with moderate to severe postoperative pain; it found that a propoxyphene-acetaminophen combination was about as effective as another pain medication called tramadol but was less effective than ibuprofen.
While the FDA continues to sort this out, the takeaway message for patients, Fishman says, is that "doctors need to talk with patients about this when they prescribe it." He adds: "This is a drug that should only be used with a patient-physician relationship."
* Acetaminophen "is a safe medicine if taken properly," Gallagher says. A primary concern about acetaminophen, Gallagher and other experts say, is that it's in so many products—from OTC pain medicines like Tylenol to certain combination allergy, sinus, and cold medications, some OTC sleeping aids and certain prescription opioids, such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone). That means that if you're taking OTC acetaminophen for occasional pain, you need to check the labels of any additional medication to be sure you're not taking too much.
Indeed, McNeil Consumer Healthcare, the maker of Tylenol, made this point in a statement posted on its website following the FDA's public meeting on acetaminophen in late June. The company advises reading drug labels and following directions, not taking more than the suggested dose, and never taking more than one acetaminophen-containing product at one time. In addition, the drug's label warns that people who consume three or more alcoholic beverages per day should consult their doctors about whether it's safe to take Tylenol because of the concern about liver damage. Symptoms of liver damage include nausea, vomiting, and loss of appetite—which, the FDA warns, can be mistaken for the flu. If you suspect liver problems, seek prompt medical attention because it can quickly progress to liver failure, or even death, within several days, according to the FDA. Also, if you already have liver disease, or if you take the blood thinner warfarin (which, taken along with acetaminophen, can increase the risk of bleeding), talk to your doctor before taking any medication containing acetaminophen.
Paying attention to drug labels and knowing what's in your medications before adding another one are particularly important among the elderly, who "will be more likely to have chronic pain, first of all, but also need pain medications to help function at a higher level," Gallagher says. People taking multiple meds might consider developing a running tally, such as this one provided by the American Society of Health-System Pharmacists. (The FDA offers this tip: Acetaminophen is sometimes abbreviated as "APAP" on prescription drugs. And in countries other than the United States, acetaminophen may be known by a different name.)
Earlier this year, the FDA called for manufacturers of drugs containing acetaminophen to add stronger warning labels about the risk of liver damage. In June, an FDA advisory panel voted in favor of lowering the maximum daily dose of OTC acetaminophen from its current level of 4 grams—or about eight pills of Extra Strength Tylenol—but did not specify a new recommended maximum daily dose. The FDA says that taking just slightly more than the maximum recommended daily dose of acetaminophen can lead to liver injury because the currently recommended 4 grams per day leaves only a small margin of error. The FDA panel voted in favor of limiting the maximum single dose of this drug to 650 milligrams, compared with the 1,000 milligrams of acetaminophen a person would consume when taking two Extra Strength Tylenols, for example. The panel voted in favor of making a 1,000-milligram dosage available only by prescription.
The advisory panel also voted for a ban on Vicodin and Percocet, stemming in part from a concern about the potential for abuse and many people's tendency to take more of these medications than recommended because of a mistaken assumption that consuming more of these drugs will provide better pain relief without an increased risk of adverse health effects. The panel encouraged banning the drugs in their current form, as combination opioid-acetaminophen products. "The advisory board was suggesting that they only be made available separately," meaning that hydrocodone and oxycodone should be sold only as single drugs, rather than in combination with acetaminophen, Fishman says. The FDA typically follows the recommendations of its advisory panel, though not always, as in the case of propoxyphene.
As an OTC alternative, aspirin, ibuprofen (found in Motrin and Advil, for example), and naproxen (found in Aleve) "can be quite effective in reducing pain and reducing inflammation," Christo says. But these drugs, in a class called nonsteroidal anti-inflammatory medications, or NSAIDs, carry their own risks. Stomach problems, including ulcerations and an increased bleeding risk, are concerns for those taking NSAIDs. For certain types of pain—in your back, neck, or legs, for example—complementary and alternative medicine treatments are also an option.