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Maternal Child

Maternal Child HealthCCC CornerMarch 2008
OB/GYN CCC Corner - Maternal Child Health for American Indians and Alaska Natives

Volume 6, No. 3, March 2008

Abstract of the Month | From Your Colleagues | Hot Topics | Features   

Hot Topics

Obstetrics | Gynecology | Child Health | Chronic Disease and Illness

Obstetrics

Evidence Favors Late Cord Clamping in Infants

Background: Most physicians who deliver babies will clamp and cut the umbilical cord immediately upon delivery, but there is no evidence that this practice is optimal. Early cord clamping has been shown to result in a decrease in the neonate's blood volume, and may be associated with hypovolemia and hematopoietic stem cell and iron loss. Conversely, late clamping may result in complications associated with high blood volume (e.g., jaundice, respiratory distress, polycythemia). In the preterm infant, late clamping has been linked to a decreased need for transfusion and decreased intraventricular hemorrhage. This study is a systematic review evaluating the timing of cord clamping in term infants.

The Study: Hutton and Hassan reviewed studies addressing the risks and benefits of early versus late cord clamping, with outcomes related to respiratory status, anemia, polycythemia, jaundice, and specific laboratory values.

Results: Of 37 studies identified, eight randomized trials and seven nonrandomized trials, six of which were rated as high quality, were included. Early clamping was defined in most studies as clamping within the first 10 seconds of birth, and late clamping was defined as occurring with cessation of cord pulsations or at three minutes (two minutes was the minimal cutoff for definition of late clamping in this meta-analysis).

Of 1,912 newborns represented in the 15 studies identified, 1,001 underwent late clamping and 911 underwent early clamping. Hematocrit levels, as measured at hours or days after delivery, were higher with late cord clamping, but the difference was not significant at six months. Similarly, the higher hemoglobin levels found with late cord clamping were no longer significant at two to three months of age.

Blood volume in infants with late clamping was higher in some trials and not significantly different in others, especially with increasing passage of time. Three trials reported higher blood viscosity with late clamping. Mean bilirubin levels were similar regardless of clamping approach. Several trials found higher ferritin levels and iron stores with late clamping. In terms of clinical outcomes, infants with late clamping had lower risk of anemia at 24 to 48 hours and at two to three months of age. When ferritin levels were considered, infants were at lower risk of anemia at six months as well. There were no differences in rates of jaundice. Polycythemia risk within the first few days of life was greater in infants who underwent late cord clamping. Clamping approach had no apparent effect on tachypnea or respiratory distress, or neonatal intensive care unit admission.

Conclusion: Late cord clamping had a beneficial effect on infants' anemia risk and iron stores, an effect that lasted well into the neonatal period. Increased viscosity and polycythemia were associated with late clamping, but did not appear to have any clinical adverse effects. The authors conclude that these findings are particularly important in geographic areas with few resources, where late cord clamping would be the most beneficial approach.

Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. March 21, 2007;297(11):1241-1252. http://www.ncbi.nlm.nih.gov/pubmed/17374818

OB/GYN CCC Editorial comment:

Similar finding in preterm infants

A study published in the March 2007 issue of Pediatrics looked at the effects of late cord clamping on cerebral oxygenation in preterm infants.1 The study of infants at a median age of 30.4 weeks found that infants with late cord clamping had similar cerebral blood volumes but higher tissue oxygenation than infants delivered in the conventional manner. Although this study did not evaluate the clinical impact of this finding, it does identify another high-risk group that could benefit from late cord clamping.

Baenziger O, Stolkin F, Keel M, et al. The influence of the timing of cord clamping on postnatal

cerebral oxygenation in preterm neonates: a randomized, controlled trial. Pediatrics.

2007;119(3):455-459 http://www.ncbi.nlm.nih.gov/pubmed/17332197

Continuous suturing for perineal closure vs interrupted methods - Less pain: Cochrane

AUTHORS' CONCLUSIONS: The continuous suturing techniques for perineal closure, compared to interrupted methods, are associated with less short-term pain. Moreover, if the continuous technique is used for all layers (vagina, perineal muscles and skin) compared to perineal skin only, the reduction in pain is even greater.

Kettle C et al Continuous versus interrupted sutures for repair of episiotomy or second degree tears. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000947 .

http://www.ncbi.nlm.nih.gov/pubmed/17943747

Minor trauma in pregnancy: Commonly used measures not predictive of adverse outcome

RESULTS: Of the 317 patients evaluated for minor trauma, 9 had a positive KB test (2.8%). Delivery information was available on 256 (81%) patients, and there was 1 placental abruption. The 49 cases (19.4%) of composite outcome could not be predicted.

CONCLUSION: Perhaps it is time to reevaluate the extensive evaluations often done after minor trauma in pregnancy, particularly because none of the commonly used objective measures are predictive of adverse outcomes.

Cahill AG et al Minor trauma in pregnancy--is the evaluation unwarranted? Am J Obstet Gynecol. 2008 Feb;198(2):208.e1-5. http://www.ncbi.nlm.nih.gov/pubmed/18226625

Amphetamine hospitalizations doubled: Familiarize yourself with the adverse outcomes

RESULTS: From 1998 to 2004, the hospitalization ratio for cocaine abuse decreased 44%, whereas the hospitalization ratio for amphetamine abuse doubled. Pregnancy hospitalizations with a diagnosis of amphetamine abuse were geographically concentrated in the West (82%), and were more likely to be among women younger than 24 years than the cocaine-abuse or non-substance-abuse hospitalizations. Most medical conditions were more prevalent in the amphetamine-abuse group than the non-substance-abuse group. When the substance abuse groups were compared with each other, obstetric diagnoses associated with infant morbidity such as premature delivery and poor fetal growth were more common in the cocaine-abuse group, whereas vasoconstrictive effects such as cardiovascular disorders and hypertension complicating pregnancy were more common in the amphetamine-abuse group. CONCLUSION: As pregnancy hospitalizations with a diagnosis of amphetamine abuse continue to increase, clinicians should familiarize themselves with the adverse consequences of amphetamine abuse during pregnancy and evidence-based guidelines to deal with this high-risk population. LEVEL OF EVIDENCE: III.

Cox S et al Hospitalizations with amphetamine abuse among pregnant women. Obstet Gynecol. 2008 Feb;111(2):341-7. http://www.ncbi.nlm.nih.gov/pubmed/18238971

Pregnant smokers reluctant to use smoking cessation medications recommended

RESULTS: At end of pregnancy, 29.3% of respondents reported discussing a cessation medication with their obstetric providers, more often nicotine replacement (26.5%) than bupropion (12.2%) (P=.001). Ten percent of trial respondents used a medication while pregnant (7.4% nicotine replacement, 3.4% bupropion, P=.023). Obstetricians discussed medication with 29.4% of smokers at the postpartum visit; 14.3% of postpartum smokers used medication. Contrary to guidelines, women who smoked more cigarettes per day or had already tried quitting during pregnancy were not more likely to use medication or to discuss medication with their provider. Medication use was associated with older age, more education, living with a partner, a previous birth, having an obstetric provider who discussed medication, and having private health insurance in a state whose Medicaid program did not cover cessation medications (all P<.05).

CONCLUSION: Pregnant women are more reluctant to use cessation medications than clinical guidelines recommend. More pregnant smokers might use cessation medications if their obstetricians discussed them routinely and if health insurance covered their cost.

Rigotti NA et al Smoking cessation medication use among pregnant and postpartum smokers.Obstet Gynecol. 2008 Feb;111(2):348-55.

http://www.ncbi.nlm.nih.gov/pubmed/18238972?dopt=Abstract

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Gynecology

Biofeedback Reduces Psychological Burden in Older Women With Urge UI

In older women with urge urinary incontinence (UI), biofeedback (BFB) therapy significantly improved psychological burden, especially in those with a history of depression.

CONCLUSION: In older women with urge UI, BFB significantly improves psychological burden, especially in those with a history of depression, in whom psychological burden is linked to change in perception of control. Psychological factors are relevant outcome measures for UI, and these data suggest that focusing on UI frequency alone may have underestimated BFB's efficacy and additional therapeutic benefits.

Tadic SD, et al Effect of biofeedback on psychological burden and symptoms in older women with urge urinary incontinence. J Am Geriatr Soc. 2007 Dec;55(12):2010-5

http://www.ncbi.nlm.nih.gov/pubmed/18028340

Not enough evidence to evaluate routine antibiotic prophylaxis with SAB: Cochrane

MAIN RESULTS: One study involving 140 women was included. A second well-conducted trial was excluded because of high losses to follow-up. No differences were detected in postabortal infection rates with routine prophylaxis or control. However, compliance with antibiotic treatment was also low. AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate a policy of routine antibiotic prophylaxis to women with incomplete abortion.

May W et al Antibiotics for incomplete abortion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001779 http://www.ncbi.nlm.nih.gov/pubmed/17943756

Intracervical catheter placement: Less pain during an saline infusion sonohysterography

CONCLUSION: Intracervical catheter placement results in significantly less pain during an saline infusion sonohysterography and also requires half the saline volume to perform the saline infusion sonohysterogram. Therefore, routine intracervical balloon placement should be considered for saline infusion sonohysterogram. LEVEL OF EVIDENCE: I

Spieldoch RL et al Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21.

http://www.ncbi.nlm.nih.gov/pubmed/18165388

Acupuncture in dysmenorrhea: improvements in pain and quality of life

Conclusion Additional acupuncture in patients with dysmenorrhea was associated with improvements in pain and quality of life as compared to treatment with usual care alone and was cost-effective within usual thresholds.

Witt CM et al Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care.

Am J Obstet Gynecol. 2008 Feb;198(2):166.e1-8. http://www.ncbi.nlm.nih.gov/pubmed/18226614

The diagnosis and management of endometrial cancer are reviewed

This review summarizes the epidemiology, prevention, diagnosis and treatment, and prognosis of endometrial carcinoma. Although the incidence of disease has remained stable, the death rate has increased over 100% over the last two decades. Precursor lesions of complex hyperplasia with atypia are associated with an endometrial carcinoma in over 40% of cases. The percentage of obese women with endometrial cancer is increasing. The incidence of endometrial cancer in white women is twice the incidence in African-American women, but stage for stage, African-American women have a less favorable prognosis. Preoperative imaging cannot accurately assess lymph node involvement. Gross examination of depth of myometrial invasion does not have the sensitivity, specificity, and positive or negative predictive value to select women who can have lymphadenectomy safely omitted from the surgical procedure. In the absence of ideal noninvasive preoperative testing, surgical staging remains the most accurate method of determining the extent of disease. There has been an increase in surgical staging and a decrease in postoperative adjuvant pelvic radiation therapy over the past two decades. Women with a family history of hereditary nonpolyposis colorectal colon cancer are at increased risk for endometrial cancer. Conservative treatment to allow for childbearing is possible in select situations. Women with endometrial cancer should be managed by physicians experienced in the treatment of this disease

Sorosky JI. Endometrial cancer. Obstet Gynecol. 2008 Feb;111(2):436-47.

http://www.ncbi.nlm.nih.gov/pubmed/18238985?dopt=Abstract

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Child Health

Sex education: Providers need to fill gaps in adolescent knowledge

RESULTS: Representing 91.3% of sampled schools, the teacher survey response rate was 62.4%. The most frequently taught topics included HIV/AIDS (97%), STDs (96%), and abstinence-until-marriage (89%). The least frequently taught topics were emergency contraception (31%), sexual orientation (33%), condom (34%) and other contraceptive (37%) use, and abortion (39%). Abstinence-only curricula were used by 74% of teachers, but 33% of these teachers supplemented with "other" curricula. Overall, two thirds met comprehensiveness criteria based on topics taught. Curricular material availability was most commonly cited as having a "great deal" of influence on topics taught. Thirty percent had no training in sex education; training was the only significant predictor of providing comprehensive sex education in multivariable analysis.

CONCLUSION: Illinois public school-based sex education emphasizes abstinence and STDs and is heavily influenced by the available curricular materials. Nearly one in three sex education teachers were not trained. Obstetrician-gynecologists caring for adolescents may need to fill gaps in adolescent knowledge and skills due to deficits in content, quality, and teacher training in sex education.

Lindau ST et al What schools teach our patients about sex: content, quality, and influences on sex education. Obstet Gynecol. 2008 Feb;111(2):256-66.

http://www.ncbi.nlm.nih.gov/pubmed/18238961

Editorial comment : Beth Crow, Anchorage

Learning about sexuality is really important for children's health, safety, and confidence

In order to offer something that our schools lack, I teach Our Whole Lives (OWL), which is an age appropriate sexual health curriculum developed by the Unitarian Universalists of the US and Canada in conjunction with the United Church of Christ. Although there is a supplemental spiritual curriculum, the core OWL curriculum is secular. There is a male and female teaching team for each class. The teachers are trained for whatever age group they want to teach. Our training was at Planned Parenthood with municipal HIV educators and Planned Parenthood staff. The curriculum includes communication, gender identification, gender roles, sexual health and safety, anatomy, contraception, intercourse (when age appropriate), etc. The curricula is available for 5-6 year olds, 9-11 year olds, junior high and senior high school students. Parents are involved in initial meetings and with home links, but the students are in class with peers and their teaching team.

I think many European countries, in particular, Scandinavia, have comprehensive sexual health programs, which results in a fraction of the teen pregnancies and STI's that we have in the US. In addition to universal access to health care and contraception, their schools have age-appropriate sex education curricula from a very early age.

I do believe that this should be a universal curriculum, and not just for children of interested parents. Parents often can't or won't talk to their children about sexuality, so children learn about sexuality from the media, school, other children, etc. These are not reliable sources, even schools, as the article by Landau shows. The sequelae of inadequate sex education is an increasing rate of teen STI's, sexual violence, and pregnancy. The U.S. needs to be proactive about our health care spending by instituting a universal, comprehensive, age-appropriate, sexual education. This will lead to a healthier, more confident, safer young population.

Obstet Gynecol Editorial

Phipps MG. Consequences of inadequate sex education in the United States. Obstet Gynecol. 2008 Feb;111(2):254-5.. http://www.ncbi.nlm.nih.gov/pubmed/18238960

Physical Activity Twice Weekly Helps Prevent Teens From Becoming Overweight Adults

School-based and extracurricular physical activities in which teens participate at least 2 times per week are effective ways to help prevent them from becoming overweight in adulthood.

CONCLUSION: These data underscore the important role that school-based and extracurricular physical activity play in reducing the likelihood of transitioning to overweight as young adults.

Menschik D et al Adolescent physical activities as predictors of young adult weight. Arch Pediatr Adolesc Med. 2008 Jan;162(1):29-33.

http://www.ncbi.nlm.nih.gov/pubmed/18180409

Early menarche associated with increased all-cause mortality

An inverse association was found between age at menarche and the all-cause mortality rate (p < 0.001), with an approximately 2.4% (95% confidence interval: 1.6, 3.1) reduced mortality per year increase in age at menarche. The association was stronger in women with an attained age of less than 70 years (3.9% reduction in mortality) than in women aged 80 years and above (1.5%). The inverse association could not be explained by extreme mortality rates in women with very early (10 years) or late (19 years) menarche or by possible confounding variables such as birth cohort, place of residence, occupational category (own or husband's occupation), body mass index, age at first delivery, or parity. Because of lack of data, residual confounding by physical activity or cigarette smoking could not be ruled out. Women with a menarche at age 18 years or later had, however, a slightly higher mortality rate than was predicted by the linear association.

Jacobsen BK et al Association of low age at menarche with increased all-cause mortality: a 37-year follow-up of 61,319 Norwegian women. Am J Epidemiol. 2007 Dec 15;166(12):1431-7. Epub 2007 Sep 17. http://www.ncbi.nlm.nih.gov/pubmed/17875585

School-Associated Student Homicides --- United States, 1992—2006

Homicide is the second leading cause of death among youths aged 5--18 years in the United States. The finding that <1% of all homicides in this population during July 1999--June 2004 were school associated is consistent with estimates from previous studies and indicates that the risk for student-associated homicides in schools is very low.

Overall rates of school-associated student homicide during July 1999--June 2006 are lower than those reported when the SAVD study was first conducted (July 1992--July 1994). Data for 1999--2006 have patterns that are similar to those documented previously, with substantially higher homicide rates among male students and students in urban areas, and homicides involving single victims occurring more frequently than those with multiple victims. SAVD data continue to indicate that individual violent events involving numerous homicides, such as the 1999 event that involved 15 deaths at Columbine High School in Colorado, are rare. Most school-associated student homicides continue to involve a single victim and a single offender.

Because each incident of school violence is different, lethal school violence cannot be eliminated using a single approach. However, research on school-associated violent deaths has described patterns in the timing of violent events and the characteristics of incidents and behaviors that precede violence (e.g., bullying experiences, suicidal ideation, and a high prevalence of threats and warning signs) that could be targets for prevention measures.

Most lethal youth violence does not occur in schools, and most acts of youth violence do not lead to death. Therefore, youth violence prevention measures should focus on a range of aggressive behaviors by addressing risk factors at individual, family, and community levels and in a range of locales. Such strategies should be guided by reviews of empirically validated prevention programs and guidelines for promoting school safety, reducing risk for youth violence and suicide, and comprehensive crisis planning. The National Youth Violence Prevention Resource Center provides information about youth violence prevention for students, parents, researchers, and others (available at http://www.safeyouth.org ).

MMWR Weekly January 18, 2008 / 57(02);33-36

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5702a1.htm

Mediterranean diet in pregnancy helps ward off childhood asthma and allergy

Mums to be who eat a Mediterranean diet while pregnant could help stave off the risks of asthma and allergy in their children, suggests research published ahead of print in Thorax.

CONCLUSION: Our results support a protective effect of a high level of adherence to the Mediterranean Diet during pregnancy against asthma-like symptoms and atopy in childhood.

Chatzi L et al Mediterranean Diet in pregnancy protective for wheeze and atopy in childhood. Thorax. 2008 Jan 15; http://www.ncbi.nlm.nih.gov/pubmed/18198206

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Chronic Disease and Illness

Diuretics most effective blood pressure medicine for people with metabolic syndrome

CONCLUSIONS: The ALLHAT findings fail to support the preference for calcium channel blockers, alpha-blockers, or angiotensin-converting enzyme inhibitors compared with thiazide-type diuretics in patients with the MetS, despite their more favorable metabolic profiles. This was particularly true for black participants.

Wright JT Jr, Clinical outcomes by race in hypertensive patients with and without the metabolic syndrome: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2008 Jan 28;168(2):207-17.

http://www.ncbi.nlm.nih.gov/pubmed/18227370

'Aspirin resistance' linked to increased cardiovascular events and death

CONCLUSION: Patients who are resistant to aspirin are at a greater risk of clinically important cardiovascular morbidity long term than patients who are sensitive to aspirin.

Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis. BMJ. 2008 Jan 26;336(7637):195-8. http://www.ncbi.nlm.nih.gov/pubmed/18202034

FDA MedWatch- Chantix (varenicline)-Associated With Reports Of Changes In Behavior

FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Healthcare Professional Information Sheet and the prescribing information for Chantix regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline

Chronic constipation more pronounced in women and the elderly

RESULTS: In all, 5507 (79%) subjects responded to the initial survey and 2298 (55%) subjects responded to the second survey in which chronic constipation could be defined. Over 12 years, the cumulative incidence of chronic constipation was 17.4% (14.5, 20.5). Among those less than age 50 years at baseline, the incidence of chronic constipation differed by gender (9.2% in men vs. 18.3% in women). In those over 70 years, the incidence of chronic constipation was more similar for men and women (20.6% vs. 25.0%). The other risk factor associated with new onset chronic constipation was the presence of abdominal pain at baseline [OR = 2.0 (1.3, 3.0)]. CONCLUSION: The cumulative incidence of chronic constipation over more than a decade was almost one in six, and more pronounced in women and the elderly.

Choung RS, et al Cumulative incidence of chronic constipation: a population-based study 1988-2003. Aliment Pharmacol Ther. 2007 Dec;26(11-12):1521-8.

http://www.ncbi.nlm.nih.gov/pubmed/17919271

Older Women More Susceptible to Depression Than Older Men

Older women are more prone to depression and are more likely to remain depressed than older men. The Yale team also found that women were less likely to die while depressed than older men, indicating that women live longer with depression than men. This factor, along with the higher likelihood of women becoming depressed and remaining depressed, collectively contribute to the higher burden of depression among older women.

CONCLUSION: Among older persons, the higher burden of depression in women than men seems to be attributable to a greater susceptibility to depression and, once depressed, to more persistent depression and a lower probability of death.

Barry LC et al Higher burden of depression among older women: the effect of onset, persistence, and mortality over time. Arch Gen Psychiatry. 2008 Feb;65(2):172-8.

http://www.ncbi.nlm.nih.gov/pubmed/18250255

Antiepileptic Drugs- Had Approximately Twice The Risk of Suicidal Behavior Or Ideation

FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

Botox And Botox Cosmetic: Reports of Respiratory Compromise And Death

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA's Early Communication about an Ongoing Safety Review regarding this issue at:  http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox

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OB/GYN

Dr. Neil Murphy is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Murphy is very interested in establishing a dialogue and/or networking with anyone involved in women's health or maternal child health, especially as it applies to Native or indigenous peoples around the world. Please don't hesitate to contact him by e-mail or phone at 907-729-3154.

This file last modified: Wednesday August 27, 2008  1:29 PM