scholarly journals Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex

Sexual Health ◽  
2020 ◽  
Vol 17 (1) ◽  
pp. 91 ◽  
Author(s):  
Aaron J. Siegler ◽  
Lauren Ahlschlager ◽  
Elizabeth M. Rosenthal ◽  
Patrick S. Sullivan ◽  
Colleen F. Kelley ◽  
...  

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Oluwasolape Olawore ◽  
Trevor A. Crowell ◽  
Sosthenes C. Ketende ◽  
Habib O. Ramadhani ◽  
Hongjie Liu ◽  
...  

Abstract Background This study reports on the individual and partnership characteristics that influence consistent condom use in cisgender men who have sex with men (MSM) and transgender women (TGW) attending trusted community centers that provide HIV prevention and treatment services in Nigeria. Methods Adults assigned male at birth who reported anal sex with male partners who enrolled between March 2013–2019 and had information about at least one male sexual partner were included in these analyses. At enrollment and follow-up visits every 3 months for up to 18 months, participants were administered detailed questionnaires that collected information about demographics, sexual practices, HIV risk behaviors, and characteristics and behaviors of their partners in the previous year (at enrollment) or the preceding 3 to 6-months (at follow-up visits). Logistic regression models with generalized estimating equations were used to assess the odds ratio (OR) and 95% confidence intervals (CI) of individual, partner, and partnership characteristics associated with consistent condom use (CCU). A participant was defined as consistently using condom if they reported always using condoms all the time they had insertive, receptive or both types of anal sex with a male partner. Results At the individual level, CCU was positively associated with higher education, disclosure of key population status to a healthcare worker and negatively associated with poor access to condoms. At the partner and partnership level, CCU was associated with partners with higher education (aOR: 1.36; 95% CI: 1.07–1.72), casual relationships (aOR: 1.22; 95% CI: 1.11–1.34) and relationships in which partners encouraged the participant to use condoms with other partners (aOR: 1.14; 95% CI: 1.02–1.28). Relationships in which the partner was married to a woman and/or the partner’s HIV status positive or unknown were negatively associated with CCU. Conclusions These findings suggest that individuals in relationships where partners were more open and encouraged safer sex were more likely to consistently use condoms. HIV prevention programs should consider leveraging communication to sexual partners to encourage condom use as this may support condom use with other sexual partners. Given sustained and growing HIV and STI epidemics among MSM and TGW, even with pre-exposure prophylaxis scale-up, it is crucial to continue to study optimal implementation strategies to increase condom use.


2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.


2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.


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