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Objective: To describe the individual characteristics, clinical features, and morbidity associated with syncope following immunization. Design: Large case series. Setting: United States, 1990 through 1995. Subjects: Reports to the national Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system. An additional 3 reports of head injury (documented by medical records) were obtained through the National Vaccine Injury Compensation Program. Main Outcome Measures: Syncope, syncope and hospitalization, or syncope and head injury within 12 hours of vaccination. Results: A total of 697 cases of syncope after vaccination was reported. Age younger than 20 years was reported for 77.4%; 57.5% were female. Hospitalization was reported in 9.6%. Of the 571 syncope events with known time, 511 occurred 1 hour or less after vaccination. Of these, 323 (63.2%) occurred 5 minutes or less, 454 (88.8%) occurred 15 minutes or less, and 500 (97.8%) occurred 30 minutes or less after vaccination. Tonic or clonic movements, which have been associated with the anoxia of vasovagal syncope, were reported in 30.4% of syncopal episodes occurring 15 minutes or less after and in 12.8% of those occurring 15 minutes or longer after vaccination (P[is less than].001). Six patients suffered skull fracture, cerebral bleeding, or cerebral contusion after falls; 3 of these patients required neurosurgery. Falls occurred 15 minutes or less after vaccination, in or near the clinic or office. Ages ranged from 12 to 28 years; 5 of 6 were male. Follow-up revealed substantial residual impairment in 2 patients. Conclusions: Prevention of injury from syncope after vaccination and of syncope itself may be possible in many cases. Vaccinators should be aware that patients exhibiting presyncopal signs and symptoms around the time of immunization need to be evaluated carefully and may need to be assisted to sit or lie down after immunization until free of symptoms., Fainting may occur after vaccination. Data analysis of the national Vaccine Adverse Event Reporting System over a five-year period revealed 700 cases of fainting. Six patients experienced skull fractures or bleeding or bruising of the brain, three of which required surgery. Nearly 45% displayed seizure-like movements, which could lead to unnecessary diagnostic tests. Ninety percent of fainting episodes occurred within 15 minutes of vaccination. Clinicians giving vaccinations should ask patients who display symptoms of impending fainting to sit or lie down and should have patients sit in a waiting area for 15 minutes after vaccination.

The human immunodeficiency virus (HIV) is the causative agent of AIDS. It attacks and destroys the immune system, thereby reducing the ability to fight infection. People with HIV infection are at greater risk for developing other infections that are life-threatening. Tuberculosis is common in patients with the HIV/AIDS syndrome, and the increase in the incidence of tuberculosis has been attributed, in part, to the HIV/AIDS epidemic. It is estimated that 70 percent of the adults in Kinshasa, Zaire, are infected with Mycobacterium tuberculosis (M. tuberculosis), and that 5 to 7 percent of the adults have HIV. The incidence of tuberculosis in patients with AIDS is dependent on infection with both HIV and M. tuberculosis. A retrospective study was performed to determine the incidence of tuberculosis among 249 mothers with HIV and 310 mothers without HIV infection, living in Kinshasa, Zaire. During a 32-month follow-up period, 19 of the HIV-positive mothers developed tuberculosis, while tuberculosis occurred in only 1 HIV-negative mother. It is estimated that HIV infection was responsible for 35 percent of the total incidence of proven pulmonary tuberculosis. Ten percent of the women with HIV infection died during the follow-up period, while 26 percent of the women who had both HIV and tuberculosis died. These findings indicate that tuberculosis combined with HIV infection is associated with a poor prognosis, and that tuberculosis is common during the final stages of HIV infection prior to death. It is concluded that the HIV/AIDS epidemic has contributed to the increasing incidence of and death from tuberculosis in Kinshasa. (Consumer Summary produced by Reliance Medical Information, Inc.)

Infection with the human immunodeficiency virus (HIV) increases the risk of infection with Mycobacterium tuberculosis, the organism that causes tuberculosis. The increased prevalence of tuberculosis since 1984 is associated with the epidemic of HIV infection and AIDS. In 1987, the Centers for Disease Control (CDC) revised the definition of AIDS to include HIV infection with extrapulmonary tuberculosis, or tuberculosis involving organs other than the lungs. Between October 1987 and March 1989, 1,239 cases of AIDS with extrapulmonary tuberculosis were reported to the CDC. The demographic characteristics of the patients and their risk factors for AIDS were assessed to help identify those persons with AIDS who are at highest risk for developing extrapulmonary tuberculosis. Extrapulmonary tuberculosis developed in 1,013 United States-born persons with AIDS as compared with 26 Mexican-born persons, 82 persons born in Haiti, and four people born in Cuba. Extrapulmonary tuberculosis rarely developed in AIDS patients less than 10 years old. Black race, intravenous drug use, transmission of AIDS by heterosexual intercourse, and Hispanic ethnicity were associated with extrapulmonary tuberculosis. In 1988, HIV-infected patients with extrapulmonary tuberculosis accounted for 21 percent of all the patients with extrapulmonary tuberculosis in the United States. (Consumer Summary produced by Reliance Medical Information, Inc.)

Introduction:Severe, chronic periodontitis (CP) is typically treated either with scaling and root planing (SRP) or surgical therapy in an effort to gain clinical attachment. The advantage of non‐surgical therapy is decreased morbidity to the patient; however, the site typically heals by formation of a long junctional epithelium. The advantage of surgical therapy is access for debridement and the use of bone or bone substitutes in combination with a barrier membrane for epithelial exclusion. Compared with a non‐surgical approach, surgical therapy is more invasive, and patient acceptance of treatment is typically more challenging. The use of lasers in dentistry appears to be rapidly increasing, as evidenced by the influx of new lasers into the dental market as well as numerous anecdotal reports of beneficial results with their use. Case Series:This report presents a novel approach to the treatment of severe CP using a carbon dioxide (CO2) laser in combination with SRP. This study presents the findings of 17 patients (nine males and eight females, aged 34 to 71 years; mean age: 54 years) that were compared in a split‐mouth design and followed for 3 months. To the best of the authors’ knowledge, this is the first reported case series using a CO2laser for de‐epithelialization in combination with SRP for the treatment of CP. Conclusion:Sites treated with the CO2laser tended to show a greater decrease in probing depths, greater amounts of recession, and greater gains in clinical attachment levels, but the results were not statistically significantly better than SRP alone.

Background:The objective of this case series is to compare root defect coverage results and healing responses of bilateral recession defects treated with acellular dermal matrix (ADM) with and without recombinant human platelet‐derived growth factor (rhPDGF). Methods:Seventeen patients with 40 bilateral gingival recession defects were compared. Each defect was ≥2 mm and treated with ADM and a coronally advanced flap. Using split‐mouth design, the control‐side ADM was hydrated in sterile saline, whereas the test‐side ADM was hydrated in rhPDGF. The patients were evaluated at 1 week, 1 month, 3 months, and 6 months. Standardized measurements were taken preoperatively at 3 and 6 months. Healing was clinically assessed at 1 week and 1 month post‐surgically. Results:Both test and control groups showed significant gain in root defect coverage over the 6‐month period for all individuals, with the test group showing a 69.0% gain and the control group showing a 76.7% gain. Patients divided into Miller Class I and Class III defects were also found to have a significant gain in root defect coverage over 6 months. The test group showed 84.1% gain, and the control group showed 84.7% gain for Miller Class I defects. For Miller Class III defects, the test group showed 51.5% gain, and the control group showed a 60.8% gain. One week after surgery, 35% of the test group showed better healing, whereas 15% of the control group showed better healing. One month after surgery, 20% of the test group showed better healing, whereas 15% of the control group showed better healing. Conclusion:Based on the results of this case series, there were no statistically or clinically significant differences in root defect coverage, keratinized tissue, clinical attachment level, or clinical healing for treatment of root recession with a coronally advanced flap and ADM with and without rhPDGF.

Brain function monitors have improved safety and efficiency in general anesthesia; however, they have not been adequately tested for guiding conscious sedation for periodontal surgical procedures. This study evaluated the patient state index (PSI) obtained from the SEDline monitor (Sedline Inc., San Diego, CA) to determine its capacity to improve the safety and efficiency of intravenous conscious sedation during outpatient periodontal surgery. Twenty-one patients at the periodontics clinic of Baylor College of Dentistry were admitted to the study in 2009 and sedated to a moderate level using midazolam and fentanyl during periodontal surgery. The PSI monitoring was blinded from the clinician, and the following data were collected: vital signs, Ramsay sedation scale (RSS), medications administered, adverse events, PSI, electroencephalography, and the patients' perspective through visual analogue scales. The data were correlated to evaluate the PSI's ability to assess the level of sedation. Results showed that the RSS and PSI did not correlate (r= −0.25) unless high values associated with electromyographical (EMG) activity were corrected (r= −0.47). Oxygen desaturation did not correlate with the PSI (r= −0.08). Satisfaction (r= −0.57) and amnesia (r= −0.55) both increased as the average PSI decreased. In conclusion, within the limits of this study, PSI appears to correlate with amnesia, allowing a practitioner to titrate medications to that effect. It did not provide advance warning of adverse events and had inherent inaccuracies due to EMG activity during oral surgery. The PSI has the potential to increase safety and efficiency in conscious sedation but requires further development to eliminate EMG activity from confounding the score.

The Advisory Committee on Immunization Practices' recommendations for influenza vaccination of children have expanded from the long-standing recommendation to vaccinate high-risk children aged ≥6 months, to vaccinating all 6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds (2008).

Background:Gingival recession remains an important problem in dental esthetics. A new dermal matrix material has been introduced, but its effectiveness has not been studied and compared to current dermal matrix material. The aim of this study is to compare the healing associated with a coronally advanced flap for root coverage in areas of localized tissue recession when using Alloderm (ADM) and Puros Dermis (PDM). Methods:A split‐mouth design was used for this study, with 52 contralateral sites in 14 patients with Miller Class I or III facial tissue recession. Twenty‐six sites were treated with coronally advanced flap using PDM, and 26 sites were treated with coronally advanced flap using ADM, all followed for 6 months. Clinical measurements of vertical recession, keratinized tissue, probing depths, and attachment levels were made initially, at 3 months, and at 6 months. Results:Both groups had significant improvement in the amount of recession coverage with means of 2.83 mm for the PDM and 3.13 mm for the ADM. The percentage of root coverage was 81.4% for the PDM and 83.4% for the ADM; differences between the materials were not statistically significant. Conclusions:Based on the results of this study, there was no statistical or clinical difference in the amount of root coverage, probing depth, or keratinized tissue in coronally advanced flaps for root coverage with either of the two acellular dermal matrix materials. Both materials were successful in achieving root coverage.

Rapid safety assessment of novel vaccines, especially those targeted against pandemic influenza, is a public health priority.

Kawasaki disease (KD) is a multisystemic vasculitis primarily affecting children <5 years. A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly.

This article reviews current dental education economic challenges such as increasing student tuition and debt, decreasing funds for faculty salaries and the associated faculty shortage, and the high cost of clinic operations and their effect on the future of dentistry. Management tactics to address these issues are also reviewed. Despite recent efforts to change the clinical education model, implementation of proposed faculty recruitment and compensation programs, and creation of education‐ corporate partnerships, the authors argue that the current economics of public dental education is not sustainable. To remain viable, the dental education system must adopt transformational actions to re‐engineer the program for long‐term stability. The proposed re‐engineering includes strategies in the following three areas: 1) educational process redesign, 2) reduction and redistribution of time in dental school, and 3) development of a regional curriculum. The intent of these strategies is to address the financial challenges, while educating adequate numbers of dentists at a reasonable cost to both the student and the institution in addition to maintaining dental education within research universities as a learned profession.

From July to September 1999, due to a concern of toxicity from exposure to thimerosal-containing vaccines, the American Academy of Pediatrics and U.S. Public Health Service temporarily recommended delaying the administration of first dose of hepatitis B vaccine until the age of 2–6 months for infants born to hepatitis B surface antigen negative mothers. Our objectives were to determine whether the recommendation affected the rate of perinatal hepatitis B infection in a multistate managed care population; to describe neonatal and early childhood cases of hepatitis B infection and to evaluate a possible role of the recommendation; and to assess the timeliness, with respect to the U.S. childhood immunization schedule, of vaccinations during the first 2 years of life.

Most reports of oral lesion prevalence are based on studies of atypical populations. There are no published studies on oral mucosal lesion prevalence in U.S. adults that are based on a national probability sample.

Palivizumab (Synagis) is used for prophylaxis against respiratory syncytial virus infection among children at high risk for respiratory syncytial virus disease. A number of deaths after palivizumab use among children <2 years have been reported to the Food and Drug Administration. We assessed available information, including the extent to which preexisting medical conditions may have put these children at higher than normal risk of death.

The Vaccine Adverse Event Reporting System (VAERS) is administered by the Food and Drug Administration and CDC and is a key component of postlicensure vaccine safety surveillance. Its primary function is to detect early warning signals and generate hypotheses about possible new vaccine adverse events or changes in frequency of known ones. VAERS is a passive surveillance system that relies on physicians and others to voluntarily submit reports of illness after vaccination. Manufacturers are required to report all adverse events of which they become aware. There are a number of well-described limitations of such reporting systems. These include, for example, variability in report quality, biased reporting, underreporting and the inability to determine whether a vaccine caused the adverse event in any individual report. Strengths of VAERS are that it is national in scope and timely. The information in VAERS reports is not necessarily complete nor is it verified systematically. Reports are classified as serious or nonserious based on regulatory criteria. Reports are coded by VAERS in a uniform way with a limited number of terms using a terminology called COSTART. Coding is useful for search purposes but is necessarily imprecise. VAERS is useful in detecting adverse events related to vaccines and most recently was used for enhanced reporting of adverse events in the national smallpox immunization campaign. VAERS data have always been publicly available. However, it is essential for users of VAERS data to be fully aware of the strengths and weaknesses of the system. VAERS data contain strong biases. Incidence rates and relative risks of specific adverse events cannot be calculated. Statistical significance tests and confidence intervals should be used with great caution and not routinely. Signals detected in VAERS should be subjected to further clinical and descriptive epidemiologic analysis. Confirmation in a controlled study is usually required. An understanding of the system’s defined objectives and inherent drawbacks is vital to the effective use of VAERS data in vaccine safety investigations.

Tumor necrosis factor α (TNFα) has been implicated in the pathogenesis of certain inflammatory diseases. Two TNFα-neutralizing agents are licensed in the US. Infliximab is licensed for the treatment of Crohn's disease (CD) and, when used with methotrexate, for the treatment of rheumatoid arthritis (RA). Etanercept is licensed for the treatment of RA, including juvenile RA, and, more recently, was licensed for the treatment of psoriatic arthritis. Because of the potential for decreased host resistance to infectious agents due to treatment with anti-TNFα agents, we sought to evaluate postlicensure cases of opportunistic infection, including Listeria monocytogenes, in patients treated with these products. The FDA Adverse Event Reporting System, a passive monitoring system, was reviewed to identify all reports of adverse events (through December 2001) associated with L monocytogenes infection in patients treated with infliximab or etanercept. Fifteen cases of L monocytogenes infection associated with infliximab or etanercept treatment were identified. In 14 of these cases, patients had received infliximab. The median age of all patients was 69.5 years (range 17–80 years); 53% were female. Six deaths were reported. Among patients for whom an indication for use was reported, there were 9 patients (64%) with RA and 5 patients (36%) with CD (information was not reported for 1 patient). All patients for whom information was reported were receiving concurrent immunosuppressant drugs. Postlicensure surveillance suggests that L monocytogenes infection may be a serious complication of treatment with TNFα-neutralizing agents, particularly infliximab.

A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zosterimmune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants specific educational efforts to prevent further repetitions. It also has more general implications for medical product safety surveillance. First, this problem's original detection depended on the Pregnancy Registry's open‐ended collection of information about pregnancy exposures. It could have escaped recognition through surveillance limited to pre specified potential risks. This need for unrestricted reporting and human vigilance to sift through case stories has particular relevance for efforts to re‐think methods to monitor gestational drug exposures. In addition, the problem's persistence despite initial publicity suggests that diligent surveillance may require continued follow‐up of identified safety issues. Periodic reassessments of selected preventable problems might strengthen efforts to minimize product risks. Copyright © 2002 John Wiley & Sons, Ltd.

Etanercept and infliximab are tumor necrosis factor (TNF) antagonists that have been recently approved for the treatment of rheumatoid arthritis (RA) and Crohn's disease (CD). This study was undertaken to investigate the occurrence of lymphoproliferative disorders in patients treated with these agents. Relevant data in the MedWatch postmarket adverse event surveillance system run by the US Food and Drug Administration were reviewed. We identified 26 cases of lymphoproliferative disorders following treatment with etanercept (18 cases) or infliximab (8 cases). The majority of cases (81%) were non-Hodgkin's lymphomas. The interval between initiation of therapy with etanercept or infliximab and the development of lymphoma was very short (median 8 weeks). In 2 instances (1 infliximab, 1 etanercept), lymphoma regression was observed following discontinuation of anti-TNF treatment, in the absence of specific cytotoxic therapy directed toward the lymphoma. Although data from a case series such as this cannot establish a clear causal relationship between exposure to these medications and the risk of lymphoproliferative disease, the known predisposition of patients with RA and CD to lymphoma, the known excess of lymphoma in other immunosuppressed populations, and the known immunosuppressive effects of the anti-TNF drugs provide a biologic basis for concern and justification for the initiation of additional epidemiologic studies to formally evaluate this possible association.

A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants specific educational efforts to prevent further repetitions. It also has more general implications for medical product safety surveillance. First, this problem's original detection depended on the Pregnancy Registry's open-ended collection of information about pregnancy exposures. It could have escaped recognition through surveillance limited to pre specified potential risks. This need for unrestricted reporting and human vigilance to sift through case stories has particular relevance for efforts to re-think methods to monitor gestational drug exposures. In addition, the problem's persistence despite initial publicity suggests that diligent surveillance may require continued follow-up of identified safety issues. Periodic reassessments of selected preventable problems might strengthen efforts to minimize product risks. Copyright © 2002 John Wiley & Sons, Ltd.

Two tumor necrosis factor α (TNFα) antagonists were recently licensed in the US. Infliximab was licensed in 1998 for the treatment of Crohn's disease (CD), and since 1999, it has been licensed in combination with methotrexate for treatment of rheumatoid arthritis (RA). Etanercept was licensed in 1998 for treatment of RA and, more recently, for juvenile RA and psoriatic arthritis. Because of potential immunosuppression related to use of anti-TNFα agents, we sought to identify postlicensure cases of opportunistic infection, including histoplasmosis, in patients treated with these products. The US Food and Drug Administration's (FDA) passive surveillance database for monitoring postlicensure adverse events was reviewed to identify all reports received through July 2001 of histoplasmosis in patients treated with either infliximab or etanercept. Ten cases of Histoplasma capsulatum (HC) infection were reported: 9 associated with infliximab and 1 associated with etanercept. In patients treated with infliximab, manifestations of histoplasmosis occurred within 1 week to 6 months after the first dose and typically included fever, malaise, cough, dyspnea, and interstitial pneumonitis. Of the 10 patients with histoplasmosis, 9 required treatment in an intensive care unit, and 1 died. All patients had received concomitant immunosuppressive medications in addition to infliximab or etanercept, and all resided in HC-endemic regions. Postlicensure surveillance suggests that acute life-threatening histoplasmosis may complicate immunotherapy with TNFα antagonists, particularly infliximab. Histoplasmosis should be considered early in the evaluation of patients who reside in HC-endemic areas in whom infectious complications develop during treatment with infliximab or etanercept.

It has been suggested that cancers of the testis and breast are associated with exposure to estrogens and other hormones in utero. Twin pregnancies have higher levels of pregnancy-associated hormones than singleton pregnancies, and these levels may be higher in dizygotic than in monozygotic twin pregnancies. Through a large population-based study of twins, we assessed the hypothesis that levels of pregnancy-associated hormones have etiologic importance for cancers of the testis, breast, and other sites. The incidence of all cancers among 46,767 members of the Swedish Twin Registry was compared with the incidence among the Swedish general population. We found testicular cancer excess among dizygotic twins (observed/expected [O/E] ratio=1.6, 95 percent confidence interval [CI]=1.0–2.6) that was greater for men younger than 35 years (O/E ratio=2.3, CI=1.1–4.2) compared with older men (O/E ratio = 1.2, CI=0.5–2.4). In addition, a substantially elevated incidence of breast cancer was observed in dizygotic twin women aged 20 to 29 years (O/E=6.7, CI=2.9–13.1). None of the other age or zygosity groups showed notable elevations in incidence of testicular, breast, or other cancers. We conclude that dizygotic twinship may be associated with cancer of the breast and testis among young adults. These findings support the concept that pregnancy hormones are associated with risk of testicular and breast cancer, although non-hormonal aspects of twin pregnancy that vary with respect to zygosity cannot be excluded as explanatory factors.

An hypothesis has been forwarded linking prostate cancer to low serum levels of vitamin D metabolites. We sought to test this hypothesis using sera obtained in a large, prospective cohort study. A serum bank in Washington County, Maryland (United States) has stored sera obtained from 20,305 county residents during a blood collection campaign undertaken in August through November 1974. We studied sera obtained from 61 residents who were diagnosed with prostate cancer during the period 1980 through 1992. Each prostate cancer case was matched to two controls on age (±1 yr) and race. Controls had donated blood in the same blood-collection campaign and had not been diagnosed with prostate cancer through 1992. Serum levels of vitamin D metabolites did not differ significantly between cases and controls. Mean 25-hydroxyvitamin D (25-D) levels were 34.3 ng/ml and 33.2 ng/ml, and mean 1,25-dihydroxyvitamin D (1,25-D) levels were 41.0 pg/ml and 40.1 pg/ml, in cases and controls, respectively. No statistically significant trends or differences between cases and controls were found in an analysis by quintile of serum level. We also did not observe the association of vitamin D metabolites with prostate cancer to be strongest among older men with more severe disease, as previously has been reported. In summary, although our study's power was limited, our findings provide little support for the hypothesis that vitamin D metabolite levels are associated strongly with subsequent risk for prostate cancer.

The quadrivalent human papillomavirus (qHPV) (types 6, 11, 16, and 18) recombinant vaccine was licensed by the US Food and Drug Administration (FDA) in 2006 for use in females aged 9 to 26 years. Within 1 month after licensure, the Advisory Committee on Immunization Practices recommended the vaccine for routine vaccination of girls aged 11 to 12 years. Clinical trials conducted before licensure in more than 21,000 women reported no significant differences in the incidence of solicited systemic clinical adverse events after immunization (AEFIs) between the vaccine group (59%) and the placebo group (60%). Similar rates of serious AEFIs were also found in the 2 groups.

To the Editor.—Recent studies1-3 have shown high rates of tuberculosis in selected patients with the acquired immunodeficiency syndrome (AIDS). A review of AIDS cases among inmates in New York State Department of Correctional Services facilities using the AIDS and tuberculosis registries has shown tuberculosis in 22 (6.9%) of 319 patients with AIDS. Four of the AIDS patients with tuberculosis were diagnosed with AIDS in 1983, three in 1984, four in 1985, and 11 in 1986 (through December).Study.—All of the AIDS patients with tuberculosis were male intravenous drug abusers, and one of them was also bisexual. Ten of the patients had extrapulmonary tuberculosis at the time of diagnosis: three lymphatic, two disseminated, two pleural, one meningeal, one peritoneal, and one hepatic. The date of the procedure diagnostic of tuberculosis preceded the date of AIDS diagnosis in 13 (59%) cases, occurred in the same month in seven cases