Post-Marketing Experience with an Opioid Nasal Spray for Migraine: Lessons for the Future

Cephalalgia ◽  
2006 ◽  
Vol 26 (2) ◽  
pp. 89-97 ◽  
Author(s):  
E Loder
Keyword(s):  
Nasal Spray ◽  
Drug Formulation ◽  
Opioid Medication ◽  
Post Marketing Surveillance ◽  
Future Drug ◽  
The Usa ◽  
Post Marketing ◽  
Spray Formulation ◽  
The Impact ◽  
Limited Scope

In 1992 a nasal spray formulation of butorphanol, an opioid medication intended for pain relief, was marketed in the USA on an unscheduled basis. Only a few years later, amid widespread reports of abuse and dependence, primarily in migraine patients, its manufacturer voluntarily requested the Food and Drug Administration to reschedule the drug as a Schedule IV narcotic. The events surrounding this episode are reviewed, and four problem areas that might have contributed are identified: (i) inadequate review of previous experience with other formulations of butorphanol; (ii) failure to consider the impact of disease state and drug formulation on the risk of adverse events; (iii) the limited scope of clinical trials prior to approval; and (iv) aggressive marketing efforts. The implications of these lessons for future drug development and post-marketing surveillance in the migraine field are considered.

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

scholarly journals P647 Post-marketing evaluation of reported adverse events of a multi-strain probiotic product confirms that change in manufacturing site had no impact on safety profile

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S534-S535
Author(s):  
V Panetta ◽  
I Simonelli ◽  
A Bacchieri ◽  
S Papetti ◽  
E De Stefani ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
System Organ Class ◽  
Safety Report ◽  
Post Marketing Surveillance ◽  
The Us ◽  
The Usa ◽  
Post Marketing ◽  
Probiotic Product ◽  
System Organ

Abstract Background In 2016, the manufacturing site of the multi-strain probiotic product VSL#3 changed. The present work is aimed at verifying if this change had an impact on the safety profile of the product. Methods The safety reports from post-marketing surveillance in the USA received by Alfasigma in the years 2014–2015 were compared with those received in the years 2017–2018. 2016 was not considered, because the product on the market during this year could likely come from both manufacturing sites. VSL#3 is sold in the US market as a medical food. Most of the reports were from consumers and were not medically confirmed. However, this happened in both periods, so no bias is introduced in the comparison. Each single safety report contained one or more adverse events (AEs), coded with MedDRA. The comparison between the two periods concerned primarily the number of safety reports in relation to the number of units sold. Given the similarity of trends between the total number of safety reports and sales in the two periods, the frequencies of the AEs and serious AEs were also compared at the System Organ Class (SOC) and Preferred Term (PT) level. Results More than 70% of subjects reporting an AE were women in both periods under comparison; mean age was 58; phone was the most frequent means (overall 76%). Table 1 summarises the main results. Sales and number of safety reports were higher in the second than in the first period. However, the ratio between number of reports and sales was higher in the 2014–2015 period compared with the 2017–2018 period: 3.5 vs. 2.9 reports per 10,000 units sold, respectively. Similar results were obtained when stratifying the described ratios by formulation. The percentages of reports with at least one serious AE were respectively 3.2% in the first period and 2.5% in the second. The two periods appeared to be similar even with respect to the percentages of AEs and serious AEs by SOC and PT, being the AEs under the Gastrointestinal SOC the most frequently reported, as expected. Conclusion The analyzed data show that the manufacturing site change had no impact on the safety profile of VSL#3.

scholarly journals Implant failure following pedicle based dynamic stabilization of the lumbar spine

2021 ◽  
Vol 87 (1) ◽  
pp. 191-196
Author(s):  
Hans Schauvliege ◽  
Marc Du Bois ◽  
Jan Verlooy
Keyword(s):  
Lumbar Spine ◽  
Group Versus ◽  
Dynamic Stabilization ◽  
Implant Failure ◽  
Failure Rates ◽  
Factors Affecting ◽  
Post Marketing Surveillance ◽  
Significant Difference ◽  
Post Marketing ◽  
The Impact

Pedicle-based dynamic stabilization (PBDS) devices such as Dynesys are promoted as an alternative and less invasive option for rigid stabilization of one and even more levels of the lumbar spine. Promising features of the Dynesys system, as well as shortcomings, became obvious in several clinical studies. Since 2012, we started using a new PBDS device as an alternative for the Dynesys, to avoid the screw loosening and the kyphosing effect. The objective is to compare failure rates between the Dynesys and Balan-C type PBDS implant and factors affecting outcome. In a retrospective study we investigated a total of 90 patients with lumbar pedicle screw dynamic stabilization (a group of 64 patiënts with Dynesys stabilization is compared to a group of 26 patients with Balan-C stabilization). Mean follow-up was 48 and 38 months, respectively. Using logistic regression analysis the impact of baseline characteristics such as gender, age, body mass index (BMI), indication for surgery, primary or revision surgery, single versus more level surgery, surgeon’s experience and type of the implant on implant failure was analyzed. We found a statistically significant difference in failure rates between the two systems (13% in the Dynesys group versus 62% in the Balan-C group). In multivariate analysis, type of implant was associated with implant failure (odds ratio : 13). Our current results call for an optimization of the pre-and post-marketing surveillance of pedicle-based dynamic stabilization.

EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana
Keyword(s):  
Data Base ◽  
Clinical Case ◽  
Drug Information ◽  
Case Record ◽  
Post Marketing Surveillance ◽  
Japanese Character ◽  
Record Data ◽  
Post Marketing ◽  
On Line ◽  
Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy
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