scholarly journals P76 The effect of the pregnancy and lactation labeling rule on prescribing information of FDA-approved drugs

2019 ◽  
Vol 104 (6) ◽  
pp. e48.2-e48
Author(s):  
A Patel ◽  
M Mazer-Amirshahi ◽  
G Fusch ◽  
A Chan ◽  
J van den Anker ◽  
...  
Keyword(s):  
Specific Pattern ◽  
Pharmaceutical Companies ◽  
Limited Data ◽  
Lactating Women ◽  
Category System ◽  
Pregnancy And Lactation ◽  
Approved Drugs ◽  
Fda Approved Drugs ◽  
Prescribing Information

BackgroundThe U.S. Food and Drug Administration implemented the new Pregnancy and Lactation Labeling Rule (PLLR) in June 2015. Under PLLR, all new drug applications were to present a narrative risk assessment (as opposed to letter category), while drug approvals after June 2001, were required to phase in by June 2020. The purpose of this study was to assess the quality of presented pregnancy and lactation data in the drug labeling and degree of adherence to the PLLR.Design/MethodsWe reviewed the labeling data of all new molecular entities (NMEs) approved from 1999–2017. The pregnancy and lactation information was classified as: 1. Harmful to use 2. Safe to use 3. Consideration of safety and efficacy. For drugs approvals after June 2001, presence of pregnancy letter category system was noted.ResultsOf the 456 NMEs, 131 (29%) were classified as harmful to use in pregnancy and 207 (45%) as harmful to use during lactation. This number did not follow any specific pattern over the course of 19 years. Less than 1% of drugs were deemed to be safe during pregnancy or lactation. Human data was the source of pregnancy or lactation information for only 2% of drugs. Up to 70% of drugs belonged to each implementation schedule has yet to meet the PLLR compliance requirement.Conclusion(s)Pregnant and lactating women are mostly advised against use of medications that might be needed for their health and health of their infants based on very limited data. Pharmaceutical companies lagged behind the required adherence rule for labeling updates on pregnancy and lactation information.Disclosure(s)Nothing to disclose

scholarly journals Emerging Therapeutic Modalities against COVID-19

2020 ◽  
Vol 13 (8) ◽  
pp. 188 ◽  
Author(s):  
Shipra Malik ◽  
Anisha Gupta ◽  
Xiaobo Zhong ◽  
Theodore P. Rasmussen ◽  
Jose E. Manautou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Small Molecules ◽  
Therapeutic Interventions ◽  
Pharmaceutical Companies ◽  
The Novel ◽  
Comprehensive Overview ◽  
Therapeutic Modalities ◽  
Academic Researchers ◽  
Approved Drugs ◽  
Fda Approved Drugs

The novel SARS-CoV-2 virus has quickly spread worldwide, bringing the whole world as well as the economy to a standstill. As the world is struggling to minimize the transmission of this devastating disease, several strategies are being actively deployed to develop therapeutic interventions. Pharmaceutical companies and academic researchers are relentlessly working to investigate experimental, repurposed or FDA-approved drugs on a compassionate basis and novel biologics for SARS-CoV-2 prophylaxis and treatment. Presently, a tremendous surge of COVID-19 clinical trials are advancing through different stages. Among currently registered clinical efforts, ~86% are centered on testing small molecules or antibodies either alone or in combination with immunomodulators. The rest ~14% of clinical efforts are aimed at evaluating vaccines and convalescent plasma-based therapies to mitigate the disease's symptoms. This review provides a comprehensive overview of current therapeutic modalities being evaluated against SARS-CoV-2 virus in clinical trials.

scholarly journals Habitual Choline Intakes across the Childbearing Years: A Review

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4390
Author(s):  
Emma Derbyshire ◽  
Rima Obeid ◽  
Christiane Schön
Keyword(s):  
Brain Function ◽  
Population Level ◽  
Food Composition ◽  
Life Stages ◽  
Lactating Women ◽  
Dietary Surveys ◽  
Pregnancy And Lactation ◽  
Choline Intake ◽  
Global Food

Choline is an important nutrient during the first 1000 days post conception due to its roles in brain function. An increasing number of studies have measured choline intakes at the population level. We collated the evidence focusing on habitual choline intakes in the preconceptual, pregnancy, and lactation life stages. We conducted a review including studies published from 2004 to 2021. Twenty-six relevant publications were identified. After excluding studies with a high choline intake (>400 mg/day; two studies) or low choline intake (<200 mg/day; one study), average choline intake in the remaining 23 studies ranged from 233 mg/day to 383 mg/day, even with the inclusion of choline from supplements. Intakes were not higher in studies among pregnant and lactating women compared with studies in nonpregnant women. To conclude, during the childbearing years and across the globe, habitual intakes of choline from foods alone and foods and supplements combined appear to be consistently lower than the estimated adequate intakes for this target group. Urgent measures are needed to (1) improve the quality of choline data in global food composition databases, (2) encourage the reporting of choline intakes in dietary surveys, (3) raise awareness about the role(s) of choline in foetal–maternal health, and (4) consider formally advocating the use of choline supplements in women planning a pregnancy, pregnant, or lactating.

Comparing the Metabolome of a Caribbean Sponge to 420 FDA Approved Drugs, a Molecular Networking Approach

Planta Medica ◽  
2013 ◽  
Vol 79 (10) ◽  
Author(s):  
H Houson ◽  
J Schlesser ◽  
J Beverage ◽  
V Macherla ◽  
E Esquenazi
Keyword(s):  
Molecular Networking ◽  
Approved Drugs ◽  
Fda Approved Drugs

Resistance to Lettuce Infectious Yellows Virus in Melon

HortScience ◽  
1998 ◽  
Vol 33 (3) ◽  
pp. 534b-534
Author(s):  
James D. McCreight
Keyword(s):  
Cucumis Melo ◽  
Dominant Gene ◽  
Field Tests ◽  
Single Dominant Gene ◽  
Limited Data ◽  
Sweetpotato Whitefly ◽  
Sources Of Resistance ◽  
Lettuce Infectious Yellows Virus ◽  
Greenhouse Tests

Yellowing of melon (Cucumis melo L.) incited by lettuce infectious yellows virus (LIYV) reduces yield and fruit quality of infected plants. LIYV is transmitted only by the sweetpotato whitefly (Bemisia tabaci Genn.). Two naturally infected field tests indicated several potential sources of resistance to LIYV. PI 124112 and `Snake Melon' had mild symptoms in both field tests whereas PI 313970 was asymptomatic in the test in which it was included. In greenhouse tests using controlled inoculation, PI 313970 was asymptomatic, had negative ELISA assays for LIYV, and was negative for LIYV in serial transfers to Chenopodium. `Top Mark' and `PMR 5' were symptomatic, had positive ELISA assays for LIYV, and were positive for LIYV in serial transfers to Chenopodium in these greenhouse tests. Limited data indicate that resistance in PI 313970 is conditioned by a single, dominant gene.

Targeting COVID-19 in Parkinson’s patients: Drugs repurposed.

2020 ◽  
Vol 27 ◽  
Author(s):  
Firoz Anwar ◽  
Salma Naqvi ◽  
Fahad A. Al-Abbasi ◽  
Nauroz Neelofar ◽  
Vikas Kumar ◽  
...  
Keyword(s):  
Day Treatment ◽  
Treatment Options ◽  
Developed Countries ◽  
Methyl Transferase ◽  
Comt Inhibitors ◽  
Mao B ◽  
Pharmacokinetic Properties ◽  
Us Fda ◽  
Approved Drugs ◽  
Fda Approved Drugs

: The last couple of months have witnessed the world in a state of virtual standstill. The SARS-CoV-2 virus has overtaken globe to economic and social lockdown. Many patients with COVID-19 have compromised immunity, especially in an aged population suffering from Parkinson disease (PD). Alteration in dopaminergic neurons or deficiency of dopamine in PD patients is the most common symptoms affecting 1% population above the age of 60 years. The compromised immune system and inflammatory manifestation in PD patients make them an easy target. The most common under trial drugs for COVID-19 are Remdesivir, Favipiravir, Chloroquine and Hydroxychloroquine, Azithromycin along with adjunct drugs like Amantadine with some monoclonal antibodies. : Presently, clinically US FDA approved drugs in PD includes Levodopa, catechol-O-methyl transferase (COMT) inhibitors, (Entacapone and Tolcapone), Dopamine agonists (Bromocriptine, Ropinirole, Pramipexole, and Rotigotine), Monoamine oxidase B (MAO-B) inhibitors (Selegiline and Rasagiline), Amantadine and Antimuscarinic drugs. The drugs have established mechanism of action on PD patients with known pharmacodynamics and pharmacokinetic properties along with dose and adverse effects. : Conclusion and relevance of this review focus on the drugs that can be tried for the PD patients with SAR CoV-2 infection, in particular, Amantadine approved by all developed countries a common drug possessing both antiviral properties by downregulation of CTSL, lysosomal pathway disturbance and change in pH necessary to uncoat the viral proteins and antiParkinson properties. The significant prognostic adverse effect of SARS-CoV-2 on PD and the present-day treatment options, clinical presentation and various mechanism is warrant need of the hour.

Pd Catalyzed N1/N4 Arylation of Piperazine for Synthesis of Drugs, Biological and Pharmaceutical Targets: An Overview of Buchwald Hartwig Amination Reaction of Piperazine in Drug Synthesis

2018 ◽  
Vol 15 (2) ◽  
pp. 208-220 ◽  
Author(s):  
Vaibhav Mishra ◽  
Tejpal Singh Chundawat
Keyword(s):  
Bond Formation ◽  
Catalyst Design ◽  
Biologically Active ◽  
Reaction Conditions ◽  
Biological Targets ◽  
Amination Reaction ◽  
Drug Synthesis ◽  
Substituted Piperazine ◽  
Approved Drugs ◽  
Fda Approved Drugs

Background: Substituted piperazine heterocycles are among the most significant structural components of pharmaceuticals. N1/N4 substituted piperazine containing drugs and biological targets are ranked 3rd in the top most frequent nitrogen heterocycles in U.S. FDA approved drugs. The high demand of N1/N4 substituted piperazine containing biologically active compounds and U.S. FDA approved drugs, has prompted the development of Pd catalyzed C-N bond formation reactions for their synthesis. Buchwald-Hartwig reaction is the key tool for the synthesis of these compounds. Objective: This review provides strategies for Pd catalyzed C-N bond formation at N1/N4 of piperazine in the synthesis of drugs and biological targets with diverse use of catalyst-ligand system and reaction parameters. Conclusion: It is clear from the review that a vast amount of work has been done in the synthesis of N1/N4 substituted piperazine containing targets under the Pd catalyzed Buchwald-Hartwig amination of aryl halides by using different catalyst-ligand systems. These methods have become increasingly versatile as a result of innovation in catalyst design and improvements in reaction conditions. This review gives an overview of recent utilization of Buchwald-Hartwig amination reaction in drug/target synthesis.

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