FDA warning on anesthesia in pregnant women slammed
Web-based therapy relieves insomnia
RBy Ronnie Cohen
epeated or lengthy use of general anesthetic and sedation drugs in infants, toddlers and pregnant women in their third trimester might damage children’s developing brains, the US Food and Drug Administration warned this month.
Upset that the warning about pregnant women was based solely on animal studies, the American College of Obstetricians and Gynecologists, or ACOG, shot back its objection.
“ACOG is unaware of data on pregnant women that support the FDA’s claims,” the group said in a practice advisory to its members. “These warnings may cause patients and providers to inappropriately reject the use of these medically indicated drugs.”
Dr Chris Zahn, vice-president of practice activity for ACOG, said that the nonprofit, which represents physicians who care for women, and the FDA have had a close working relationship and in the past have discussed similar warnings before they were announced. But the warning about pregnant women and anesthesia was different.
“We were caught entirely off guard, and we are concerned about the practical applicability of this warning and its potentially negative impact on women’s health, particularly pregnant women,” Zahn said in a phone interview.
On Dec 14, the FDA issued a safety announcement urging that healthcare providers, parents and patients weigh the potential benefits against the risks while considering the timing of non-emergency surgery, particularly for pregnant women in their third trimester and children less than 3 years old.
The FDA based its safety advisory - and a requirement that drug manufacturers add warning labels on 11 anesthetic and sedation drugs - on both clinical human studies and animal studies. But the human studies include only children, not pregnant women.
Studies have shown that more than three hours of general anesthetic and sedation drugs in pregnant and young animals caused widespread loss of nerve cells in the offspring’s brains, FDA spokeswoman Sarah Peddicord said. Research showing adverse effects on behavior and brain development has been done in multiple animal species, from flatworms to non-human primates.
Asked why the FDA included pregnant women without clinical evidence of a problem, Peddicord said, “This is something we have been looking at, and based on the information we have, we thought it was important to get the information to the public.”
Web-based therapy for insomnia is an effective option that could reach “previously unimaginable numbers of people,” researchers suggest. Although cognitive behavior therapy for insomnia (CBT-I) is the first-line treatment for adults with chronic insomnia, there arenít enough trained clinicians to deliver the treatment, according to Dr Lee Ritterband of the University of Virginia School of Medicine in Charlottesville and colleagues.
To investigate whether web-based CBT-I is effective over the long term and might enable more people to benefit, the team randomly assigned 303 adults with chronic insomnia to a six-week automated, interactive and tailored web-based program (Sleep Healthy Using the Internet, or SHUTi, at www.myshuti.com) or an online, nontailored patient education program about insomnia.
To be included in the study, participants had to take more than half an hour to fall asleep at the beginning of the night or be awake for more than half an hour after initially falling asleep at least three nights per week for at least six months; average 6.5 hours or less sleep time nightly; and experience significant stress or impaired functioning due to sleep disturbances. About half of participants also had at least one medical or psychiatric condition.
Most of the participants — 77 in the SHUTi group (51 percent) and 69 in the patient education group (46 percent) — had taken a sleep aid at least once. The research team reports in JAMA Psychiatry that SHUTi was significantly more effective than the patient education program with respect to insomnia severity, delay until sleep onset and time awake after sleep onset. By one year, insomnia was no longer a problem for 57 percent of SHUTi participants versus 27 percent of those receiving education.
In addition, 70 percent of SHUTi participants had seen at least some improvement, compared to 43 percent of participants who received education.