False‐positives in spontaneous reporting: should we worry about them?

Bégaud, Bernard; Moride, Yola; Tubert‐Bitter, Pascale; Chaslerie, Anicet; Haramburu, Françoise

doi:10.1111/j.1365-2125.1994.tb04373.x

Cited by 82 publications

(36 citation statements)

References 13 publications

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“…Tumor stage (for short-term BMT in patients with breast cancer and long-term BMT in patients with ovarian cancer) and a comorbidity score (for patients with breast cancer) were significant predictors of BMT. Physicians should continue to report suggestive temporal associations between new drugs and bone marrow suppression [39] and caution should be exercised when interpreting such reports. Given aforementioned limitations of clinical studies in addressing the issue of chemotherapeutic toxicities, observational studies serve as a practical option in post-marketing situations because they reflect ''real world'' [40].…”

Section: Discussionmentioning

confidence: 96%

Chemotherapy use and risk of bone marrow suppression in a large population-based cohort of older women with breast and ovarian cancer

Nurgalieva

Liu

2010

Med Oncol

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We studied 65,521 women with breast cancer and 7,420 women with ovarian cancer aged ≥ 65 identified from the 16 areas of the Surveillance, Epidemiology and End Results program linked with Medicare data during 1991-2002. Bone marrow toxicity associated with chemotherapy was defined using diagnosis codes from Medicare inpatient, outpatient and physician claims. The time to event Cox regression was utilized to estimate the risk of bone marrow toxicity. Use of anthracyclines, taxanes or platinums was associated with increased risks of short- (≤3 months) and long-term (>3 months) anemia and neutropenia in patients with breast cancer. Alkylating agents or antimetabolites were additional significant predictors of anemia in women with ovarian cancer. Patients who received chemotherapy (irrespective of regimens) were twice (breast cancer) or three times (ovarian cancer) as likely to develop thrombocytopenia compared to those not receiving chemotherapy. Among women with breast cancer, patients receiving cyclophosphamide, methotrexate and fluorouracil regimens (hazard ratio=19.0, 95% CI=11.2-32.5), platinum/taxane therapy (21.9, 11.9-40.4) or the cyclophosphamide, adriamycin and fluorouracil regimen (32.5, 19.6-53.9) were strongly associated with risk of aplastic anemia. There was a dose-response relationship between the use of taxane or platinum and the risk of bone marrow suppression, whereas the increased risk of bone marrow toxicity was consistently higher in those with use of alkylating agents or anthracycline-based regimens irrespective of the increasing number of cycles received. In conclusion, there was an association between chemotherapy use and clinical manifestations of bone marrow toxicities in a population-based setting.

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Section: Discussionmentioning

confidence: 96%

Chemotherapy use and risk of bone marrow suppression in a large population-based cohort of older women with breast and ovarian cancer

Nurgalieva

Liu

2010

Med Oncol

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“…Most serious adverse events of botulinum toxin come from spontaneous reporting systems and case reports [46,47]. However, spontaneous reporting systems cannot be used to determine the incidence of adverse events, as adverse events are underreported and neither patient exposure nor the amount of time the drug was in the market has been taken into consideration.…”

Section: Discussionmentioning

confidence: 99%

Serious and Long-Term Adverse Events Associated with the Therapeutic and Cosmetic Use of Botulinum Toxin

Yiannakopoulou

2015

Pharmacology

108

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Although botulinum toxin is generally considered safe, its widespread use and the constantly expanded indications raise safety issues. This study aimed to review the serious and long-term adverse events associated with the therapeutic and cosmetic use of botulinum toxin. Serious adverse events included dysphagia, respiratory compromise, generalized muscle weakness, marked bilateral ptosis, pseudoaneurysm of the frontal branch of the temporal artery, necrotizing fasciitis, sarcoidal granuloma, Fournier gangrene, and cervical kyphosis. Death was attributed to botulism or anaphylactic shock. In conclusion, botulinum toxin may cause serious adverse events, which are more common after its therapeutic use, but can also be noticed after its cosmetic use. Thorough knowledge of the anatomy of the treated muscles and of the pharmacology of the drug is imperative to avoid serious adverse events.

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“…Two-way interaction terms were evaluated. Both fixed effects and random effects models using generalized estimating equations were calculated (19). Finally, to simultaneously evaluate the effects of clustering due to wound care center and patient, we evaluated effect estimates using a generalized linear latent and mixed model (GLLAMM) (20).…”

Section: Discussionmentioning

confidence: 99%

Diabetic Neuropathic Foot Ulcers

et al. 2002

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OBJECTIVE -The goal of this study was to evaluate whether simple risk factors can be identified that successfully characterize who will heal and who will not heal among patients who have received standard therapy for diabetic neuropathic foot ulcers.RESEARCH DESIGN AND METHODS -For this cohort study, we evaluated Ͼ31,000 individuals with a diabetic neuropathic foot ulcer seen in the Curative Health Services System. Using multivariate logistic regression, we evaluated the association between wound size, wound duration, wound grade, and other variables and their effect on whether a patient would heal by the 20th week of care.RESULTS -We demonstrated that wound size, wound duration, and wound grade are all significantly associated with the likelihood of a wound healing by the 20th week of care. In addition, we noted that these associations were not significantly affected by the treating wound care center, whether the unit of analysis was one wound on a patient or all of their wounds, or current adjuvant therapies.CONCLUSIONS -We have shown that three easy-to-measure risk factors are associated with a wound healing. These results should help clinicians understand the likelihood that a wound will heal and help those conducting clinical investigations to design better trials. Diabetes Care 25:1835-1839, 2002L ower-extremity ulcers are a serious complication of diabetes. More than 16 million people in the U.S. have diabetes, and 15% of them can expect to develop a foot ulcer at some point in their lives (1-3). Diabetic patients admitted to the hospital with lower-extremity ulcers were hospitalized longer on average than those who were hospitalized and did not have ulcers (1,3). Whereas only 4% of the population has diabetes, 46% of those admitted to a hospital with a foot ulcer had diabetes, and half of all lower-extremity amputations in hospitalized patients occurred in diabetic patients (1,3). Those with a lower-extremity amputation have a diminished quality of life and increased health costs, often have many concomitant medical ailments, are more likely to have the contralateral limb amputated, and are more likely to die within the next 5 years than those with no amputation (4,5).There are many pathways for the development of a diabetic foot ulcer. In general, they include a combination of lowerlimb arterial insufficiency, lower-limb diabetic neuropathy, and local trauma (6). About 20% of diabetic patients with foot ulcers will primarily have inadequate arterial blood flow, ϳ50% will primarily have diabetic neuropathy, and ϳ30% will be afflicted with both conditions (1,6). Inadequate arterial blood flow is usually treated by a variety of surgical techniques that improve blood flow (7). For this study, foot ulcers on individuals with diabetes who lack protective sensation and have adequate arterial blood flow to their foot are termed diabetic neuropathic foot ulcers (DNFUs) (8 -10).The treatment of a DNFU usually consists of debridement of necrotic tissue, use of a moist wound dressing, and the use of a device that p...

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False‐positives in spontaneous reporting: should we worry about them?

Abstract: 1 Spontaneous reporting remains the most used and, undoubtedly, the most costeffective approach for the identification of adverse drug reactions (ADRs

Cited by 82 publications

References 13 publications

Chemotherapy use and risk of bone marrow suppression in a large population-based cohort of older women with breast and ovarian cancer

Chemotherapy use and risk of bone marrow suppression in a large population-based cohort of older women with breast and ovarian cancer

Serious and Long-Term Adverse Events Associated with the Therapeutic and Cosmetic Use of Botulinum Toxin

Diabetic Neuropathic Foot Ulcers

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