Category Archives: Pain Medicine

Too little, too late for many New Yorkers seeking hospice

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By Fred Mogul, WNYC

Sandra Lopez and her Chihuahua, Coco, were inseparable. He followed her everywhere, and kept Lopez’s mood up when she was in pain – which was often.

On Oct. 15, Lopez, died at age 49 of pancreatic and vaginal cancer that had slowly spread throughout her body over two years. She left behind a 15-year-old daughter and little Coco. But with hospice care, she spent her last weeks where she wanted to be — at home, with her pain under control.

Sandra was in and out of the hospital in 2014, but for the months she was home, a hospice nurse from Metropolitan Jewish Health System visited once a week to help manage the pain, backed up by a 24-hour, nurse-staffed phone line that Lopez called often.

“Some days the pain is so excruciating,” she told me in August from the couch in her Brooklyn apartment, “that the pain overrides the medication.”

But despite evidence that hospices can greatly relieve discomfort, extend life and save money, and despite a generous hospice benefit available through both Medicare and Medicaid, relatively few people in New York take advantage of it, compared to elsewhere in the country.

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Cambia gives its largest grant ever to UW Medicine: $10 million for palliative care – Puget Sound Business Journal

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Dr. Randy Curtis, right, director of the UW Palliative Care Center of Excellence.

Dr. Randy Curtis, right, director of the UW Palliative Care Center of Excellence.

The grant is Cambia’s largest ever given to any organization and will come in four separate parts, creating three endowments totaling $8 million and $2 million dedicated to immediately improving care at the center.

via Cambia gives its largest grant ever to UW Medicine: $10 million for palliative care – Puget Sound Business Journal.

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Vicodin, some other pain meds will be harder to get – DEA

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Patients who use drugs containing hydrocodone as a pain reliever or cough suppressant are going to have to jump through more hoops to get them starting next month.

The Drug Enforcement Administration is reclassifying so-called “hydrocodone combination products” (HCP) from Schedule III to Schedule II under the Controlled Substances Act, which will more tightly restrict access. Vicodin, for example, is an HCP because it has hydrocodone and acetaminophen.

The final regulation, which takes effect Oct. 6, will mean that patients generally must present a written prescription to receive the drug, and doctors will no longer be able to call in a prescription to the pharmacy in most instances.

Many patients with painful chronic diseases, including cancer, take hydrocodone combination products

.The regulation is a response to the widespread misuse of prescription pain killers.

In an emergency, doctors will still be able to call in a prescription, according to the new rule. And although prescription refills are prohibited, a doctor can, at his discretion, issue multiple prescriptions that would provide up to a 90-day supply.

These measures don’t satisfy consumer advocates or pharmacists who are opposed to the new rule. Continue reading

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Women’s health – Week 49: TMJ

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tacuin womenFrom the Office of Researcher on Women’s Health

Temporomandibular joint (TMJ) and muscle disorders are a group of conditions that cause pain and dysfunction in the jaw joint and muscles that control jaw movement.

Some estimates suggest that TMJ disorders affect over 10 million Americans and appear to be more common in women than men.

The exact cause of TMJ is not clear. Trauma to the jaw or temporomandibular joint plays a role in some TMJ disorders but, in most cases, symptoms seem to start without obvious reason.

A variety of symptoms may be linked to TMJ disorders. Pain in the chewing muscles and/or jaw joint is the most common symptom. Continue reading

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Medicare experiment could signal sea change for hospice

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Diane Meier 176By Michelle Andrews
KHN / JUL 29, 2014

Diane Meier is the director of the Center to Advance Palliative Care, a national organization that aims to increase the number of palliative care programs in hospitals and elsewhere for patients with serious illnesses.

Meier is also a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai in New York City.

We spoke about a recently launched pilot program under the health law that allows hospice patients participating in the pilot to continue to receive life-prolonging treatment. This is an edited version of that conversation.

Q. There’s a lot of confusion about how hospice care differs from palliative care. Maybe we should start by clearing up what those terms mean. Continue reading

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Medicare to consider paying doctors for end-of-life planning

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End of life factBy Michael Ollove
Stateline staff Writer

The federal government may reimburse doctors for talking to Medicare patients and their families about “advance care planning,” including living wills and end-of-life treatment options — potentially rekindling one of the fiercest storms in the Affordable Care Act debate.

A similar provision was in an early draft of the federal health care law, but in 2009, former Republican vice-presidential candidate Sarah Palin took to Facebook to accuse President Barack Obama of proposing “death panels” to determine who deserved life-sustaining medical care. Amid an outcry on the right, the provision was stripped from the legislation.

Now, quietly, the proposal is headed toward reconsideration — this time through a regulatory procedure rather than legislation. Continue reading

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Women’s health – Week 35: Pain

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From the Office of Research on Women’s Health

tacuin womenPain is often an indication or warning that something in your body is not quite right, that you should take medicine and/or see a health care provider.

At its worst, however, pain robs us of our productivity, our well-being, and, for those suffering from extended illness, our very lives.

There are two types of pain: acute and chronic. Continue reading

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Making palliative care more available to children

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Conversations matter palliative care

From the National Institute of Nursing Research

January 10, 2014 – New Palliative Care: Conversations Matter campaign helps ensure children with serious illnesses and their families get supportive care

A campaign just launched by the National Institute of Nursing Research (NINR) aims to increase the use of palliative care — comprehensive treatment of the discomfort, symptoms, and stress of serious illness — for children with serious illness.

Palliative care can reduce a child’s pain, help manage other distressing symptoms, and provide important emotional support to the child and family throughout the course of an illness. Continue reading

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Katie Schlenker

When palliative care is the best care

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By Anna Gorman
KHN Staff Writer

This KHN story was produced in collaboration with 

Katie Schlenker 300

Palliative care doctor Katie Schlenker tries to help Leanne Henry with her pain, weeks after Henry underwent a liver transplant at the University of Washington Medical Center in Seattle (Photo by Anna Gorman/KHN).

SEATTLE — Leanne Henry winced. Five weeks had passed since her liver transplant, and she hurt just lying still.

Katie Schlenker softly touched her leg. “Are you still in a lot of pain?”

Henry, a petite mother of five who has been hospitalized since early September, closed her eyes and nodded. “It’s not like an ache,” she told her doctor. “It’s pain that just won’t go away.”

Schlenker is a physician unlike most at the University of Washington Medical Center. A palliative care doctor, her role is to comfort her patients instead of cure them, to help them cope with their illnesses rather than to treat them.

When Henry was in intensive care, Schlenker stood beside her patient’s husband and children as the family prayed for recovery. They talked extensively about what the family wanted to do if Henry took a turn for the worse.

After the transplant, Schlenker and her team helped with the pain and made a “success chart” to mark Henry’s daily progress. Last month, they decorated her hospital room for fall.

“Anything I need, they are there,” Henry, 48, said.

Hospitals around the country are increasingly starting palliative care programs, designed to relieve seriously ill patients’ pain, stress and symptoms regardless of how long they have to live.

While some patients are close to death, others are still receiving treatment to extend their days. And as they do, the palliative care team, including doctors, social workers, nurses and chaplains, tries to improve their quality of life.

Palliative care teams help patients with issues not always addressed by medical doctors. They help manage symptoms such as nausea, difficulty sleeping and fatigue, and they coordinate with the doctors providing treatment.

They also provide patients and families with emotional and spiritual support, helping them understand the illness and guiding them through tough treatment choices.

More than two-thirds of hospitals with more than 50 beds offer palliative care, up from 25 percent in 2000, according to the Center to Advance Palliative Care at Mount Sinai School of Medicine. Washington is a leader in the field; more than 80 percent of hospitals have such programs.  The field is recognized as a subspecialty, and there are fellowships, journals and research centers devoted to the topic.

The increase in popularity is in part due to the growing number of people with chronic illness who may not be ready for hospice. Medicare only pays for hospice benefits if patients have six months or less to live and agree to forgo treatment that prolongs life.

“You shouldn’t be days or weeks from death to have your symptoms managed and pain taken care of,” said R. Sean Morrison, director of the National Palliative Care Research Center.

But some doctors are resistant to palliative care because they believe it pushes patients away from medical treatment that could help them fight their illnesses.

Even the idea of patients planning ahead and making decisions about their care has caused controversy. A provision that would have paid doctors for having discussions about living wills with their patients was taken out of the Affordable Care Act after conservatives raised concerns over “death panels.”  An Oregon congressman is trying to revive that discussion with a similar proposal.

Regardless of what happens with the legislation, experts said palliative care programs will continue to grow as baby boomers age and as hospitals look for ways to reduce costs and increase value under the nation’s new health care law.

Studies show that palliative care reduces health care spending by avoiding unnecessary treatment and getting patients out of the hospital faster. Researchers have also concluded that the care improves patient satisfaction and lengthens life.

The way forward in medicine isn’t just blind application of technology to treat disease, said Tony Back, a University of Washington professor, an oncologist and an expert in the field. “Fear drives people to think there’s got to be a way to fix this,” he said. “There are better ways to deal with serious illness.”

On a rare sunny afternoon in Seattle, palliative care physician Melissa Bender stepped into the hospital room of Susanne Becklund, who was wearing a patterned red scarf around her head.

Becklund was diagnosed with leukemia in July and had only been out of the hospital for a few days since. She had undergone chemotherapy and bone marrow biopsies. Nothing had worked.

“All in all, it doesn’t sound promising,” Becklund said.

Becklund, 63, said she knew she might not make it until summer but that she didn’t have a big agenda. She just wanted to get out of the hospital and breathe in fresh air every day. She hoped to take a walk alongside a favorite river.

“What gives you strength during hard times?” Bender asked.

Becklund responded that she just puts “one foot in front of the other.” But since finding out that there was little the doctors could do to treat her cancer, that’s gotten a lot harder. “I’m trying to get stronger, but for what?” Becklund asked.

Bender let silence fill the room before speaking again. She promised to help Becklund live the rest of her life as she wanted. “Continuing everything you are on will keep you in and out of the hospital,” she said of Becklund’s medical treatment. “Stopping some of those things will help you get home.”

Patients sometimes refuse to see the palliative care team, worrying that doctors are giving up on them or sending them home to die. But the way Bender sees it, she is listening to what they want and trying to help them get the most out of life.

Henry wants to return to her home on Whidbey Island within a few weeks but knows that may not be realistic. Since entering the hospital for her liver problems, she has had complication after complication.

In early September, Henry was so sick that her organs were shutting down, and she was hooked to a ventilator. Doctors repeatedly told her husband that she wasn’t going to make it. Schlenker and social worker Carol Kummet asked what the family wanted to do.

“I told them that she is a mother of five and that she could struggle through this,” said her husband, Dan Henry. “We didn’t want to give up.”

Finally, on Sept. 24, she got a new liver. But the problems didn’t end there. She has suffered from infections and blood loss and needed several more surgeries. The recent pain sent her to the operating room again. As Henry moved throughout the facility — the operating room, the emergency room, the transplant floor— Schlenker and her team have been familiar faces.

Henry, wearing orange nail polish and a thin coat of lip gloss, said she feels like she can say anything to them.  Most of the time, Henry is motivated to get better, but sometimes she just wants to give up. Schlenker told her she was there to support her, no matter how she felt.

“You’ve had lots of ups and downs,” Schlenker said. “It’s okay to have a bad day and to be frustrated and be angry.”

Jack Brewer, a 61-year-old welder from Alaska, has had his ups and downs too. He was airlifted to Seattle after having a massive heart attack in October. Now, Brewer is connected to an artificial heart, a machine that beats in place of his own. “That is what is keeping him going till he gets a heart transplant,” said his daughter, Amy Snow.

Jack Brewer 300

Jack Brewer, who had a heart attack in October, lies in a hospital bed at the University of Washington Medical Center in Seattle. His children, Amy Snow and Austin Brewer, stand by their father’s side. Snow said the palliative care team makes her father feel more like a person than a patient (Anna Gorman/KHN).

Kummet, the social worker, looked at Snow and her brother, Austin Brewer, and smiled. “That is only one thing that is keeping him going,” she said.

Snow said she had to Google “palliative care” when the team visited. At first, she feared it meant he was even sicker than she thought. Soon, Snow realized they were there to help the family cope with their father’s illness and to help him be more comfortable. The team makes her dad feel more like a person than a patient, she said.

“It’s not because he’s dying,” Snow said. “It’s because he’s in a dire situation.”

Whether patients are dying or living with a serious illness, doctors are notoriously bad about having difficult conversations and about listening to what patients want, said Stu Farber, who oversees the University of Washington’s palliative care program.

On a recent morning, he explained to a group of fourth-year medical students that they would soon be treating very sick patients and needing to talk to them about their prognoses.

The talks won’t be easy, as patients express frustration, sadness and grief.  “We went into medicine to help people,” he said. “We don’t want to make people angry or to make people cry.”

On this day, students role-played those discussions with two actors: a mother and her 32-year-old daughter who was dying of cancer.  The first pair of students began by asking about the woman’s illness, but Farber redirected them to ask about her instead of her disease. He urged them to ask about her goals, hopes and fears.

Nick Vaudreuil, 25, said so much of medical school has focused only on the science so he appreciated learning how to talk to critically ill and dying patients.  “It humanizes the whole process,” he said.

For Leanne and Dan Henry, those conversations and the palliative care group have helped them deal better with the lengthy and difficult hospital stay. While the surgeons focus primarily on the medical care, Schlenker and the palliative care team focus on the emotional and spiritual care, Dan Henry said.

“They have given us hope,” he said, “while everybody else was saying we didn’t have any.”

Contact: agorman@kff.org

This article was produced by Kaiser Health News with support from The SCAN Foundation.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Addressing a dangerous epidemic: Abuse of Painkillers and other prescription drugs

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Tablet Thumb BlueBy Ankita Rao
KHN

About 50 Americans die every day from a prescription drug overdose — a tally that, in most states, turns out to be more than deaths from car accidents.

In a new report, “Prescription Drug Abuse: Strategies to Stop the Epidemic,” researchers at the Trust for America’s Health found that rates of overdose and addiction doubled since 1999 in most states.

In West Virginia — the state with the highest number of drug overdose deaths — the rate was six times higher than fourteen years ago.

During a conference call on Monday, the researchers said the emergence of prescription drugs like oxycodone has benefitted many people but is also marked by a corresponding rise in misuse.

“Working on this report, we were overwhelmed by the number of sad stories of tragedies that could have been averted,” said Jeff Levi, executive director of the Trust for America’s Health.

He said intervention strategies — ranging from the education of health providers to the correct disposal of unused medications — are proven solutions.

The Trust for America’s Health, along with other public health and law enforcement experts, reviewed national recommendations and examined a set of 10 indicators that were having a positive impact, including certain laws and educational initiatives.

But most states had in place six or less of the indicators that help curb the issue. Only New Mexico and Vermont had all 10 strategies touted by the report. South Dakota had the lowest number: two.

Levi also said a Medicaid expansion in the 24 states and District of Columbia that are expanding the federal-state health insurance program for low-income people will lead to expanded coverage of substance abuse and treatment.

Meghan Andreae, a senior case manager at the addiction services and consulting firm Southworth Associates, said many clients become addicted to painkillers first through legitimate prescriptions for a health concern but later seek out new doctors and methods to obtain the drugs.

This issue highlights the need for more awareness among physicians — one of the strategies outlined in the report — since only 22 states have laws that require or recommend continuing education for doctors and other health providers who prescribe prescription pain meds.

“I would certainly say that’s something that’s lacking,” Andreae said. “A small amount of their training is spent on this issue.”

While the report highlights the shortcomings of prescription drug abuse prevention, it also recognizes that many states are taking steps to address the issue.

Almost all state Medicaid programs have in place a pharmacy “lock-in” program that requires patients to use a single prescriber or pharmacy if they are suspected of abusing drugs.

And, in 44 states, health providers have to conduct a physical exam and screen for substance abuse before prescribing medication.

Other recommendations include:

  • Good Samaritan Laws — Measures that protect individuals from criminal charges for helping themselves or others experiencing an overdose.
  • ID Requirements — Laws requiring or permitting a pharmacist to require an ID before dispensing a controlled substance.
  • Rescue drug laws — Laws to expand access to the use of naloxone, a drug that can be effective in counteracting an overdose.

“Given the extraordinarily rapid growth of the problem, we’re also impressed by how quickly policies have emerged to get a handle on it, and how quickly many of these are showing signs of progress,” said Andrea Gielen, director of the Johns Hopkins Center for Injury Research and Policy, who was a reviewer of the report.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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FDA moves to reduce use of long-acting opioid pain drugs

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The US Food and Drug Administration has changed the labeling on long-acting opioids, such as OxyContin, in an effort to limit the use of these drugs to patients with severe refractory pain. Here’s is the Consumer Update from the FDA released today.

FDA Consumer Update

FDA logojpgConsumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.

“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research.

“Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them,” Throckmorton adds.

He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

How Labeling Will Change

Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches.

Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products.

They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.

Currently, labeling on these ER/LA opioids indicate they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever.

Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers.

It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.

FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing.

The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

Postmarket Studies

Recognizing the need for more scientific data about the benefits and risks of ER/LA opioids when used over long periods, FDA also decided to require drug companies to conduct longer term studies and trials of ER/LA opioid pain relievers on the market.

The companies must evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.

Education to Reduce Risk

Following implementation of the safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling for the ER/LA opioid pain relievers.

As part of the new labeling changes, opioid manufacturers also must revise a paper handout patients receive with their prescription.

The ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will also be updated after the labeling changes are finalized.

The ER/LA Opioid Analgesics REMS requires manufacturers to make available continuing education courses for health care professionals who prescribe these drugs.

The courses, from accredited sources, teach about risks and safe prescribing and safe use practices of these medications.

“By improving information about the risks of ER/LA opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products,” says Throckmorton.

He adds: “This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Sept 10, 2013

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FDA warns of rare acetaminophen risk

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A Consumer Update from the US Food and Drug Administration

ucm363013Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin.

If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines.

Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names.

It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions.

Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen.

FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section.

On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”

Ingredient Linked to Several Conditions

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

A serious skin reaction can occur at any time, even if you’ve taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

If you’ve ever had a skin reaction when taking acetaminophen, don’t take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

Evidence of Link

Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen.

In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA’s strongest warning, used for calling attention to serious risks.

The agency continues to consider the benefits of this medication to outweigh the risks.

“FDA’s actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen,” says Hertz. “Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

August 1, 2013

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Attorneys general seek warning label cautioning pregnant women against using pain pills

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Illustration showing two pill bottlesBy Maggie Clark
Stateline Staff Writer

Forty-three state attorneys general, including Washington state Attorney General Bob Ferguson, are calling for new “black box” warning labels on prescription painkillers that can harm unborn children.

In a letter sent Monday to the U.S. Food and Drug Administration, the attorneys general point to an alarming spike in the number of babies born with “neonatal abstinence syndrome,” or drug withdrawal symptoms experienced by babies when they are cut off from the opioid drugs ingested by their mothers. The symptoms include tremors, seizures, poor weight gain and fever.

“We believe that a ‘black box warning’ for these medications would help ensure that women of childbearing age – as well as their health care providers – are aware of the serious risks associated with narcotic use during pregnancy,” the attorneys general wrote in the letter addressed to FDA Commissioner Margaret Hamburg.

The targeted medications include popular painkillers such as OxyContin, Vicodin, codeine, morphine and methadone, which are part of the same opioid family of drugs as the illegal drug heroin.

Nationally, about 13,500 infants were born with drug withdrawal symptoms in 2009, about one baby each hour, according to a 2012 study from the Journal of the American Medical Association.

The problem is particularly pronounced in certain states. In Kentucky, for example, instances of neonatal abstinence syndrome have increased 2500 percent over 10 years, from 29 cases in 2001 to 730 cases in 2011, according to the attorney general’s office in that state.

Babies born with neonatal abstinence syndrome require more care and risk lifelong health problems. Medicaid, a joint state-federal program, bears much of the cost: In Florida, where seven of every 1,000 infants born in 2011 experienced opioid withdrawal symptoms,

Medicaid paid for treatment for 77 percent of those babies, at a total cost of about $32 million, according to a report on prescription drug abuse and newborns. The rate of opioid-exposed babies born in Florida more than tripled between 2007 and 2011, from 2.3 to 7.5 per 1,000 live births.

In Tennessee, the average cost to the state Medicaid program of a baby born with neonatal abstinence syndrome was $40,931 in 2010. That compares with $7,258 in Medicaid benefits for a healthy birth, according to the Tennessee Department of Health.

The state ranked second in the country for number of retail prescriptions filled per person, at 17.6 prescriptions filled per person in 2011.

The black box labels the attorneys general are calling for are found on prescriptions which cause the most serious side effects, including anti-depressants or heart medications.

The new warning labels would be added to any existing black box labels on the drugs. For instance, OxyContin already comes with a black box label warning about its potential for abuse.

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Stateline is a nonpartisan, nonprofit news service of the Pew Center on the States that provides daily reporting and analysis on trends in state policy.

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FDA warns pregnant women to not use certain migraine prevention medicines

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Alert Icon with Exclamation Point!From the FDA

Valproate products can lower IQ scores in children of mothers who used them during pregnancy

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy.

Therefore, these drugs should never be used by pregnant women for the prevention of migraine headaches.

Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

Valproate products have several FDA-approved uses including: prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder)

.Medicines that contain valproate already have a boxed warning for fetal risk, including birth defects.

The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found further evidence of the IQ risk, leading to today’s strengthened warnings.

“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

For its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable.

Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.

Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately

Women should not stop taking their medication without talking to their health care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.

Women of childbearing age taking valproate products should use effective birth control.

It is not known if there is a certain time period during pregnancy when valproate exposure can result in decreased IQ. The women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.

The FDA’s strengthened recommendations are based on the final results of the NEAD study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs.

The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the antiepileptic drug.

In a June 2011 alert, the FDA released interim results from the NEAD study that showed reduced cognitive test scores in these valproate-exposed children at age 3, and at that time the drug labels were updated.

The FDA is working with the manufacturers to make changes to the drug labels to reflect this new information and to change the pregnancy category for prevention of migraine headaches to category X (the drug’s risks outweigh the drug’s benefits for this use) from category D (the drug’s benefits outweigh the drug’s risks for this use).

Valproate products will remain category D for the other two approved indications, epilepsy and manic episodes associated with bipolar disorder.

In a drug safety communication issued today, the FDA provided a summary of the new data and recommendations for health care professionals and patients.To learn more:

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