Special report: The dangers of painkillers

https://www.consumerreports.org/cro/video-hub/3705124027001/

Every year, Percocet, Vicodin, and other opioids kill 17,000 Americans and acetaminophen sends 80,000 people to the ER

America is in pain—and being killed by its painkillers.

It starts with drugs such as OxyContin, Percocet, and Vicodin—prescription narcotics that can make days bearable if you are recovering from surgery or suffering from cancer. But they can be as addictive as heroin and are rife with deadly side effects.

Use of those and other opioids has skyrocketed in recent years. Prescriptions have climbed 300 percent in the past decade, and Vicodin and other drugs containing the narcotic hydrocodone are now the most commonly prescribed medications in the U.S. With that increased use have come increased deaths: 46 people per day, or almost 17,000 people per year, die from overdoses of the drugs. That’s up more than 400 percent from 1999. And for every death, more than 30 people are admitted to the emergency room because of opioid complications.
Find out the 5 things to know about prescription painkillers.

With numbers like that, you would think that the Food and Drug Administration would do all it could to reverse the trend. But against the recommendation of its own panel of expert advisers, last December the agency approved Zohydro ER, a long-acting version of hydrocodone. “We think the benefits of the drug outweigh its risks,” says Douglas Throckmorton, M.D., who oversees regulation of drugs for the FDA. He says that Zohydro ER offers an option to some people in pain, and that the FDA has taken steps to make all opioids safer by, for example, requiring stronger warnings on drug labels. The FDA says it will also keep a close eye on how Zohydro ER is used in the marketplace.

But attorneys general from 28 states have asked the FDA to reconsider its decision because the drug offers no clear advantages over others already on the market and its potency makes it a target for misuse and abuse. And more than a dozen Republican and Democratic members of Congress have signed a bill that would ban Zohydro ER.

Opioids aren’t the only painkillers that pose serious risks. Almost as dangerous is a medication renowned for its safety: acetaminophen (Tylenol and generic). Almost 80,000 people per year are treated in emergency rooms because they have taken too much of it, and the drug is now the most common cause of liver failure in this country.

Though some of those tragedies stem from abuse, many are accidental. It’s not just that people are careless. Advice to “take only as directed” doesn’t cut it when the advice is confusing and conflicting. And with acetaminophen, the advice is exactly that. For example, the FDA has lowered the maximum per-pill dose of prescription acetaminophen, but it hasn’t taken the same step for over-the-counter products. And OTC drugmakers have wildly different notions of what people can take: Some labels advise taking no more than 1,000 milligrams of acetaminophen daily; others set the limit almost four times as high.

And with acetaminophen, accidentally taking too much is all too easy. That’s because it’s the most common drug in the U.S., found as an ingredient in more than 600 OTC and prescription medications, including allergy aids, cough and cold remedies, fever reducers, pain relievers, and sleep aids.

“All of this doesn’t mean that everyone should avoid opioids and acetaminophen altogether,” says Marvin M. Lipman, M.D., chief medical adviser for Consumer Reports. “But it does mean that the FDA should fulfill its role to protect consumers by taking strong steps to reduce the dangers, starting by reconsidering its approval of Zohydro ER and finally establishing consistent standards for acetaminophen.”

It also means you need to know the risks, not only of opioids and acetaminophen but also of drugs such as ibuprofen (Advil and generic), naproxen (Aleve and generic), and Celebrex. That last drug, now prescribed only under its brand name, should be available in the next year or so as a lower-cost generic called celecoxib. But like its nonprescription cousins, it poses serious risks to your heart and stomach when taken regularly, as millions of Americans do.

“Pain drugs can be as bad as the pain itself,” Lipman says. “So you need to know when they are really needed and how to use them safely.”

Opioids: Deadly misconceptions

One of the biggest misconceptions people have about opioids is that the risks apply to other people, not themselves. But the “typical” victim of overdose might not be whom you think. About 60 percent of overdoses occur in people prescribed the drugs by a single physician, not in those who “doctor shopped” or got them on the black market. And a third of those were taking a low dose.

Used properly, opioids can ease severe short-term pain from, say, surgery or a broken bone, and manage chronic pain from an illness such as cancer. But people run into trouble when they inadvertently misuse the drugs—combining them with alcohol or other drugs (such as sleeping pills), taking them in too high a dose or for too long, or using them while driving or in other situations when they need to be alert.

Ideally, health care professionals should act as gatekeepers, prescribing painkillers only when they’re appropriate and monitoring patients for side effects. But that’s not always done, says Richard Blondell, M.D., director of the National Center for Addiction Training at the State University of New York in Buffalo, N.Y. “No doubt, the public needs to be better educated about the risks,” Blondell says. “But ultimately this epidemic starts with the doctor’s prescription pad.”

The general public and health care providers harbor outdated and dangerous notions about opioids. Below are three of the biggest misconceptions and the facts you need to know to stay safe.

Misconception #1: Opioids work well for chronic pain.

An estimated 90 percent of people suffering long-term pain wind up being prescribed an opioid despite little evidence that the drugs help much or are safe when used long-term. “But we do know that the higher the dose and the longer you take it, the greater your risk,” says Gary Franklin, M.D., research professor of environmental and occupational health sciences at the University of Washington in Seattle. People who take opioids for more than a few weeks often develop tolerance, so they require higher doses, which in turn breeds dependence. And although higher doses can ease pain, they commonly cause nausea and constipation, disrupt your immune system and sex life, and leave you feeling too fuzzy-headed to participate in things such as physical activity that can speed your recovery. And in a cruel twist, the drugs can make some people more sensitive to pain.

The safer approach. For certain types of pain—including nerve pain, migraines, and fibromyalgia—other prescription medications usually work better than opioids. For other types of chronic pain, ask your doctor about trying OTC drugs such as acetaminophen, ibuprofen, and naproxen before prescription drugs. Nondrug measures such as exercise, massage, behavioral therapy, spinal manipulation, and acupuncture might also help. If you have chronic pain that hasn’t responded to other treatment, opioids may be an option. But your doctor should prescribe the lowest effective dose for the shortest possible time and monitor you for side effects.

Misconception #2: Opioids are not addictive when used to treat pain.

“That’s what I and a lot of other doctors learned in medical school,” Blondell says. “But we now know that’s just not true.” Somewhere between 5 percent and 25 percent of people who use prescription pain pills long term get addicted. Fewer women are dependent on prescription painkillers than men, but they may become dependent more quickly and are more likely to doctor shop.

The safer approach. Chronic pain often waxes and wanes. If you and your doctor feel you need an opioid, reserve it for flare-ups. If you take it for more than a few weeks, your doctor should advise you about early signs of addiction, including unusual moodiness, cravings, temper flare-ups, and taking unnecessary risks.

Misconception #3: Extended-release versions are safer.

Opioids such as hydromorphone (Exalgo), oxycodone (OxyContin and generic), morphine (Avinza, MS Contin, and generic), and the newly approved Zohydro ER stay in the body longer and are usually stronger than short-acting forms. They should be reserved for patients who need round-the-clock relief. But doctors sometimes prescribe them for convenience—patients need to take fewer pills—and because they believe that long-acting drugs are less likely to cause a drug “high” and lead to addiction. But there’s no evidence those drugs work better or are safer than short-acting ones. And people dependent on opioids seek out the higher potency of long-acting versions. That’s why public health groups and law-enforcement agencies fear that the new Zohydro ER is prone to abuse.

The safer approach. It’s usually best to start with a short-acting opioid. Because long-acting drugs are more likely to be stolen, misused, and abused, if your doctor prescribes one, expect careful monitoring.

Acetaminophen: Dangerous doses

When taken at recommended doses, acetaminophen is safe for most people, even when used long term. But there’s little margin for error. Exceeding the maximum recommended dose—by even a little bit—can prove toxic, especially to the liver. And that’s relatively easy to do. For example, take the maximum recommended doses for Tylenol Extra Strength for your joint pain, Nyquil Cold & Flu, and an nighttime sleep aid like Walgreens PM, and you will get 6,600 milligrams—well above the 4,000 milligrams a day that’s linked to liver damage (see chart, below).

It has long been known that large doses of acetaminophen taken at once can be fatal. But cumulative smaller doses totaling more than 4,000 milligrams (eight 500-milligram, or “extra strength,” pills) can be just as dangerous, if not more so. People who took repeat doses of the medication—for complaints such as headaches, muscle pain, and toothaches—that put them over the maximum daily amount were more likely to have brain, kidney, and liver problems, and faced a greater risk of dying or needing a liver transplant than people who had taken a single, large overdose. That’s according to a 16-year Scottish study of people treated in the emergency room published in 2011.

Read more about how to manage pain.

That same year, the FDA tried to reduce acetaminophen poisonings by limiting the prescription products to 325 milligrams per pill. The agency noted that higher doses don’t relieve pain better and that people are more likely to overdose on them.

But the agency has not yet imposed the same limits for nonprescription products, even though they account for 80 percent of the acetaminophen taken in the U.S. No doubt, that pleased OTC drugmakers: “Extra strength” products with 500 milligrams of acetaminophen per pill are big sellers.

And because acetaminophen shows up in so many products, you need to check all drug labels for acetaminophen. Then make sure you stay below the safe upper limit when you combine the pills. And you should avoid acetaminophen altogether if you are at risk for liver disease or drink alcohol heavily, because that multiplies the dangers. If you regularly take the drug, watch for signs of liver damage, including dark urine, pale stools, upper-right abdominal pain, and a yellowish tinge to the whites of the eyes.

By Consumer Reports

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Johnson & Johnson recalls hysterectomy power morcellator that may spread cancer

Healthcare company Johnson & Johnson announced that it will stop the sale and distribution of its power morcellators after the Food and Drug Administration (FDA) discouraged its use for hysterectomy, or the removal of the uterus, and myomectomy, the removal of uterine fibroids, as the
use of the device could spread undetected cancer.

Johnson & Johnson, however, said it is merely suspending the commercialization of the surgical device while awaiting update from the medical community. Findings of the study “Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation” which was published in the Journal of the American Medical Association on July 22, however, appear to have helped prompt the company to finally recall its hysterectomy power morcellators.

On Wednesday, the company said that will ask doctors to return the power morcellators it has manufactured. It also plans to reach out to customers to ask them to return the morcellators they have purchased following a company decision for a worldwide withdrawal of all its morcellation devices that still remain in the market.

Johnson & Johnson’s Ethicon unit, which makes the controversial device, said that it is pulling out the power morcellators from the market because the risks and benefits of using the device in hysterectomies and myomectomies remain uncertain.

“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” company spokesman Matthew Johnson said.

The FDA said that of the 350 women undergoing surgery using morcellators, one may have a type of cancer that can spread beyond the uterus and this spread of malignant cells to other parts of the body could have a significant impact on a woman’s chances for survival.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” William Maisel, from the FDA’s Center for Devices and Radiological Health said. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Results of the JAMA study strengthened this contention as the findings showed that 27 in every 10,000 women undergoing hysterectomy had cancerous tumors that can spread to other parts of the body by morcellation.

By Rhodi Lee, Tech Times.

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