January 12, 2021 by Carol Higgins
Roundup: FDA Broadens Warnings Against Mixing Opioids With Anxiety Meds; Weight-Loss Surgery Can Have Long-term Benefits, Study Finds
The U.S. Food and Drug Administration (FDA) wants Americans to fully understand the dangers of mixing prescription opioids to relieve pain with medications to combat anxiety or sleeping problems.
The FDA said this week that it is requiring nearly 400 products to carry a “black box warning” focusing on the risks from combined use. Those risks include extreme sleepiness, respiratory depression, coma and death.
The agency said its action comes after a review of scientific evidence showing that physicians have been increasingly prescribing these drugs together. Earlier this year, health officials in cities and states across the country petitioned the FDA to bolster warnings on drug labels after citing an increase in overdoses from the simultaneous use of these drugs.
Painkillers and cough medicines containing opioids that will be required to carry the new warning include oxycodone, hydrocodone and morphine. The benzodiazepines (the class of drugs primarily used for treating anxiety or related conditions) that will get the warning are sold under a variety of brand and generic names, including Xanax, Valium and lorazepam. They often are called tranquilizers or sleeping pills for their ability to relieve anxiety, insomnia and seizures.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf, M.D., in a statement. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or central nervous system depressants more generally – together outweigh these serious risks.”
Prescription opioids can be used to treat moderate-to-severe pain and are often prescribed following surgery or injury, or for health conditions such as cancer. But the overuse of opioids has sparked concerns among health officials and the medical community. According to the U.S. Centers for Disease Control and Prevention (CDC), unintentional overdoses on opioid prescription medications, such as Oxycontin and Percocet, quadrupled between 1999 and 2014.
- FDA to Require Warnings on ‘Immediate-Release’ Painkillers
- Back to Basics: Preventing and Treating Lower Back Pain
- Watch Now: The Opioid Epidemic in America
- From the Front Lines: Rx for Heroin Addiction
Weight-Loss Surgery Can Have Long-term Benefits, Study Finds
Weight-loss surgery can help obese people maintain a significant dropp-off in weight over a ten year period, new research has determined.
The new report is unique because few previous studies have followed weight-loss surgery patients over a long period of time.
In the two-part study by a team from Duke University School of Medicine, in Durham, N.C., the results of about 1,800 men and women who had gastric bypass surgery were evaluated. The researchers compared weight changes in gastric-bypass surgery patients to weight changes in more than 5,300 obese veterans who had no weight-loss surgery or formal weight-loss treatment.
At 10 years, the researchers had weight information about 564 of the nearly 1,800 patients who had the gastric bypass. Only 19 of them had regained so much weight that they nearly returned to their initial weight. The rest of the group kept off the weight.
Compared to the non-surgical group, the bypass group weighed 21 percent less than at the start of the study.
In gastric bypass, the stomach is reduced by dividing it into a small upper pouch and a much larger lower pouch. The small intestine is then rerouted to connect to both. Other weight-loss surgeries include adjustable gastric band and sleeve gastrectomy.
The study also found that after four years, those who had gastric bypass lost nearly 28 percent of their starting weight. People who had sleeve gastrectomy lost about 18 percent, and those with gastric banding lost about 11 percent, the researchers found.
In gastric banding, a silicone band is placed around the top end of the stomach, reducing stomach capacity and restricting food intake. A sleeve gastrectomy involves the removal of a section of your stomach, causing a reduction in food intake.
“These results provide further evidence of the beneficial association between surgery and long-term weight loss that has been demonstrated in shorter-term studies of younger, predominantly female populations,” the researchers concluded.
The average age of the men and women in the Duke University study was about 52, and three-quarters of the subjects were men.