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Health & Wellbeing
 

December 1, 2018 - December 7, 2018

FDA OKs powerful opioid pill as alternative to IV painkiller

This undated image provided by AcelRx Pharmaceuticals shows the dispenser and a tablet for the company’s medication Dsuvia. (Craig Sherod Photography/AcelRx Pharmaceuticals via AP)

Linda A. Johnson

Trenton, N.J. (AP) - U.S. regulators have approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. In a lengthy statement, FDA Commissioner Scott Gottlieb said there will be “very tight restrictions” placed on its distribution and it is intended only for supervised settings like hospitals.

The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor.

Gottlieb noted the pill was a high priority for the Department of Defense, which helped fund testing, because it wanted a way to provide fast pain relief to injured soldiers. The tablet, placed under the tongue with a dispenser, starts reducing pain in 15 to 30 minutes.

A panel of FDA advisers had earlier voted 10-3 in favor of the pill called Dsuvia (duh-SOO’-vee-uh). But in a rare response, the panel’s chairman joined critics in urging the FDA to reject it. The chairman, Dr. Raeford E. Brown Jr., who couldn’t attend the meeting and didn’t cast a vote, predicts that the pill will be abused inside and outside medical settings and cause overdose deaths.

The pills contain sufentanil, a chemical cousin of the opioid fentanyl.

Gottlieb said the drug will carry a boxed warning and won’t be available at drugstores for patients to take home. Acknowledging the criticism, he said he’s asked FDA staff to “evaluate a new framework” for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.

“We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,” Gottlieb’s wrote.

Sidney Wolfe of Public Citizen’s Health Research Group, a consumer group, called Gottlieb’s statement “empty rhetoric” and said the agency missed a big opportunity when it approved the pill.

“It’s a huge mistake,” Wolfe said. “This drug is doomed. It’s dangerous and it will kill people.”

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.

In one study, the pill provided about the same pain relief to patients as IV morphine. Common side effects with Dsuvia included nausea, vomiting, constipation and decreased blood oxygen levels. Those occurred slightly more often with the pill than for study participants given morphine.


New exercise guidelines: Move more, sit less, start younger

New federal guidelines released on Monday, Nov. 12, 2018, advise that children as young as age 3 should move more, sit less and get more active, and that any amount and any type of exercise helps health. (Aaron Marineau/The Hutchinson News via AP)

Marilynn Marchione

Chicago (AP) - Move more, sit less and get kids active as young as age 3, say new federal guidelines that stress that any amount and any type of exercise helps health.

The advice is the first update since the government’s physical activity guidelines came out a decade ago. Since then, the list of benefits of exercise has grown, and there’s more evidence to back things that were of unknown value before, such as short, high-intense workouts and taking the stairs instead of an elevator.

“Doing something is better than doing nothing, and doing more is better than doing something,” said Dr. Donald Lloyd-Jones, a preventive medicine expert at Northwestern University in Chicago.

Only 20 percent of Americans get enough exercise now, and the childhood obesity problem has prompted the push to aim younger to prevent poor health later in life.

Highlights of the advice released at an American Heart Association conference in Chicago and published in the Journal of the American Medical Association:

Children and Teens

The biggest change: Start young. Guidelines used to begin at age 6, but the new ones say preschoolers ages 3 through 5 should be encouraged to take part in active play throughout the day. They don’t call for a certain amount but say a reasonable target may be three hours of various intensities. That’s consistent with guidelines in many other countries and is the average amount of activity observed in kids this age.

From ages 6 through 17, at least an hour of moderate-to-vigorous activity throughout the day is recommended. Most of it should be aerobic, the kind that gets the heart rate up such as brisk walking, biking or running. At least three times a week, exercise should be vigorous and include muscle- and bone-strengthening activities like climbing on playground equipment or playing sports.

Adults

Duration stays the same - at least 2 to 5 hours of moderate-intensity or 1 to 2 hours of vigorous activity a week, plus at least two days that include muscle-strengthening exercise like pushups or lifting weights.

One key change: It used to be thought that aerobic activity had to be done for at least 10 minutes. Now even short times are known to help. Even a single episode of activity gives short-term benefits such as lowering blood pressure, reducing anxiety and improving sleep.

Sitting a lot is especially harmful.

The advice is similar for older adults, but activities should include things that promote balance to help avoid falls.

Brought to you by the letter E

Targeting young children is the goal of a project that Dr. Valentin Fuster, a cardiologist at New York’s Mount Sinai Hospital, has worked on for years with the Heart Association and Sesame Workshop, producers of television’s “Sesame Street.”

At the heart conference, he gave results of an intensive four-month program to improve knowledge and attitudes about exercise and health among 562 kids ages 3 to 5 in Head Start preschools in Harlem.

“It was really successful,” Fuster said. “Once they understand how the body works, they begin to understand physical activity” and its importance.

When brains are young, “it’s the best opportunity” to set health habits that last, he said.


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FDA OKs powerful opioid pill as alternative to IV painkiller

New exercise guidelines: Move more, sit less, start younger