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According to a study, a pregnant woman’s use of acetaminophen may be associated with increased risk of her child developing attention-deficit/hyperactivity disorder (ADHD). Plus: Another study says race is sole indicator of breast reconstruction likelihood. Also: FDA issues guidance on labeling for surgical aspirators.
According to a study published in Pediatrics, a pregnant woman’s use of acetaminophen may be associated with increased risk of her child developing attention-deficit/hyperactivity disorder (ADHD). The authors believe that duration of acetaminophen usage during pregnancy plays a major role in the rate of ADHD.
Using the Norwegian Mother and Child Cohort Study, the researchers looked at a sample of 112,973 offspring born between 1999 and 2009. Both mothers and fathers completed questionnaires at 18 weeks’ gestation and the mothers completed follow-up questionnaires after delivery and when their child reached 6 months, 18 months, and 3 years of age. To control for potential confounders, questions on the survey also included various medical conditions for which acetaminophen was indicated.
From that sample, 2246 (2%) children were diagnosed with ADHD and 52,707 (46.7%) mothers reported some acetaminophen use during pregnancy. Compared with mothers who reported no acetaminophen exposure, the unadjusted hazard rate (HR) of ADHD in children after 1, 2, or 3 trimesters of prepartum exposure was 17%, 39%, and 46%, respectively. When the authors adjusted for parental ADHD symptoms, the risk associated with acetaminophen reduced slightly from an HR of 1.26 to 1.20. Use of acetaminophen for any one, any two, or all three trimesters was associated with an HR of 1.07, 1.22, and 1.27, respectively.
When the pregnant mother took acetaminophen between 1 and 7 days for any indication, the HR was 0.90. In general, longer use was associated with a steady increase in risk. Acetaminophen usage for 29 days or longer carried an HR of 2.20. When the mother indicated acetaminophen use for fever and infections for 22 to 28 days, the HR spiked to 6.15, but dropped to 2.40 with use of 29 days or longer. The researchers found no association between acetaminophen use in the 6 months prior to pregnancy and ADHD in the child. But paternal use of acetaminophen for 29 days or longer had an HR of 2.06.
The authors claimed this study could have an impact on prescribing habits as they estimated that approximately 65% to 70% of pregnant women in the United States and approximately 50% to 60% of pregnant women in western and northern Europe use acetaminophen. But the authors noted some limitations to this study. These include the inability to adjust for the severity of the indications leading to maternal acetaminophen use and the accuracy of clinician ADHD diagnoses. In addition, the indication that paternal use of acetaminophen also having an effect on ADHD likelihood makes the researchers question the causal role of acetaminophen in the etiology of ADHD.
Study: Race is sole indicator of breast reconstruction likelihood
Even when insurance status and access to plastic surgeons are controlled, women of color are still far less likely to undergo breast reconstruction surgery than white women, according to a study published in The American Journal of Surgery. The study authors believe this study shows that race alone is a predictor of which patients are most likely to undergo reconstruction.
Looking at surgery databases from California, Florida, and New York (which combined represent 24 percent of the US population according to 2010 census data), the researchers identified more than 65,000 women with breast cancer who underwent a mastectomy between 2008 and 2012. Patient access to plastic surgeons was measured using a ratio of plastic surgeons per 100,000 people living in each county within those states. Patients were further grouped by insurance status (private or public) and by race.
While less access obviously led to fewer reconstructions, insurance status was also a major predictor. Of the entire study population, 60% of privately insured patients underwent reconstruction compared to 20% of patients with public insurance.
However, the study findings illustrated that race was the biggest predictor of women who were likely to undergo reconstruction. In counties with the highest ratios of plastic surgeons where access would not be a factor, white women underwent reconstruction 59% of the time, compared to 47% of Hispanic women, 42% of African-American women, and 41% of Asians, Pacific Islanders, and Native Americans (APINA). These likelihoods also followed the same trends when insurance status was factored in. White women with private insurance who live in areas with the highest plastic surgeon density underwent reconstruction 84% of the time. The rates fall to 65% of Hispanic women, 60% among African-Americans, and 24% for APINA. In the public insurance group, the rates still follow the same disparity. White women with public insurance underwent reconstruction at 34%, Hispanic women at 28%, and 24% for both African-American and APINA women.
The researchers believe that their study illustrates that race alone is the predictor of which patients will undergo reconstruction. However, they identified three areas to address which could help close the disparity. They believe more patient outreach and education will help these communities better understand their options so they can choose what is best for them. Breast oncologists and primary care physicians also need to be more vigilant in their patient referrals to plastic surgeons. Lastly, plastic surgeons need to take it upon themselves to improve the disparity. While the need for more plastic surgeons nationally exists, according to the researchers, fewer plastic surgeons are accepting insurance.
FDA issues guidance on labeling for surgical aspirators
The US Food and Drug Administration (FDA) is recommending that a specific safety statement be added to the product labels of certain ultrasonic surgical aspirators. The guidance, which is nonbinding, applies to devices indicated for use in laparoscopic surgery, open surgery, or gynecologic surgery with product codes including LFL (Instrument, Ultrasonic Surgical) and NLQ (Scalpel, Ultrasonic, Reprocessed).
Issued on October 30, the nonbinding document mirrors a draft issued by FDA on November 10, 2016. The Agency is recommending that manufacturers of the ultrasonic surgical aspirator devices with the indications previously listed include the following language in their product labeling:
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
The guidance document goes on to say that “FDA is generally not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time. FDA is recommending the contraindication in this guidance, rather than the contraindication in the laparoscopic power morcellator (LPM) guidance, in light of the fact that ultrasonic surgical aspirators are generally not intended nor used for the removal of uterine fibroids.” Issued on November 25, 2014, the LPM guidance was a warning against using such devices in management of many women undergoing hysterectomy or myomectomy. Thise action, taken 3 years ago, followed a review by the FDA and its Obstetrics and Gynecological Medical Device Advisory Panel of evidence regarding use of morcellators, which suggested that there was a higher prevalence of unsuspected uterine sarcomas (1 in 352) or leiomyosarcoma (1 in 498) in women undergoing hysterectomy or myomectomy for presumed benign fibroids than the clinical community had previously understood.
In 2014, the Agency listed two contraindications to use of the morcellators devices and a “black box” warning aimed at educating women about the potential for dissemination of unexpected malignancy with the laparoscopic power morcellator. Specifically, the FDA issued contraindications for use of the devices in: 1) gynecologic surgery in which the tissue to be morcellated is known to, or suspected to contain malignancy; and 2) removal of uterine tissue containing suspected fibroids in women who are perimenopausal or postmenopausal, or who would be candidates for en bloc tissue removal, (i.e., through the vagina or via a mini-laparotomy). The FDA further advised that providers should thoroughly discuss the risks and benefits of all treatments for uterine fibroids with their patients and inform them that fibroids may harbor unexpected cancers that could be disseminated with the laparoscopic power morcellator and adversely affect their survival.
Regarding the new guidance on the aspirators, the FDA “believes that the Contraindication is important for the safe and effective use of these ultrasonic surgical aspirator devices.” The Agency said that within 120 days of publication of the guidance, manufacturers with an existing 510(k) clearance for them should add the new verbiage to the label, submit the current and revised labeling to FDA, and provide updated labeling to previous purchasers of the devices.