Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs

Lurasidone was approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia, as well as for the treatment of bipolar depression. However, emerging reports have indicated various adverse drug reactions with the use of lurasidone. Thus, in this article, we have analyzed the risk profile of lurasidone in the established therapeutic indication. A total of 419 studies were published from October 2010-July 2019 regarding lurasidone. After the inclusion and exclusion criteria, 17 studies were selected for the analysis of risk. The adverse drug reactions (ADRs) of these studies were categorized as per the innovator summary of product characteristics (SmPC). Finally, the unlisted ADRs were analyzed by using the Naranjo probability algorithm. Telogen effluvium, thrombocytopenia, restless leg syndrome and hypersexuality were found with the use of lurasidone and fall under the unlisted category. The causality assessment has shown a probable correlation of lurasidone with hypersexuality, restless leg syndrome, thrombocytopenia and possible relation with telogen effluvium. In conclusion, lurasidone is a novel and efficacious pharmacological treatment for bipolar depression and schizophrenia. However, more data regarding the safety of this drug in a large population is needed.

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Respiratory concerns of gabapentin and pregabalin: What does it mean to the pharmacovigilance systems in developing countries?

F1000Research ◽

10.12688/f1000research.21962.2 ◽

2021 ◽

Vol 9 ◽

pp. 32

Author(s):

Sunil Shrestha ◽

Subish Palaian

Keyword(s):

United States ◽

Developing Countries ◽

Early Detection ◽

Evaluation Studies ◽

The United States ◽

Drug Reactions ◽

Prescription Monitoring ◽

Concurrent Use ◽

United States Food ◽

States Food

Gabapentin and pregabalin, commonly known as gabapentinoids, have been widely used globally. This paper highlights the serious breathing problems due to using gabapentin and pregabalin which was warned by the United States Food and Drug Administration on December, 2019. In this article, we tried to recommend suggestions for controlling these adverse drug reactions (ADRs). Safety reports of gabapentin and pregabalin should be obtained from concerned manufacturers and reviewed for respiratory depression effects. There should be strict prescription monitoring and drug use evaluation studies. Concurrent use of gabapentin and pregabalin with other respiratory depressants such as opioids should be strictly monitored. Educating patients can help in the early detection of ADRs due to gabapentin and pregabalin. Anecdotal reports on these medications should be encouraged.

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Nonprescription Drugs: An Overview

International Journal of Health Services ◽

10.2190/c9cd-1prb-g60y-xpvg ◽

1974 ◽

Vol 4 (1) ◽

pp. 125-130 ◽

Cited By ~ 5

Author(s):

Benjamin Hodes

Keyword(s):

United States ◽

The United States ◽

Health Practitioner ◽

Drug Reactions ◽

Nonprescription Drugs ◽

Safety And Efficacy ◽

United States Food ◽

Deceptive Advertising ◽

States Food ◽

Regulatory Actions

This article discusses a widely used class of medicinal agents—nonprescription drugs. The pertinent legislation affecting nonprescription drugs is reviewed historically, followed by a discussion of recent federal regulatory actions, especially those of the review panels convened by the United States Food and Drug Administration. The problems associated with nonprescription drugs are considered from the viewpoints of the health practitioner, the consumer, and the federal regulatory agency, taking into account such concerns as drug interactions, adverse drug reactions, overuse, and deceptive advertising. Finally, some problems in the assessment of the safety and efficacy of nonprescription drugs are discussed.

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Respiratory concerns of gabapentin and pregabalin: What does it mean to the pharmacovigilance systems in developing countries?

F1000Research ◽

10.12688/f1000research.21962.1 ◽

2020 ◽

Vol 9 ◽

pp. 32

Author(s):

Sunil Shrestha ◽

Subish Palaian

Keyword(s):

United States ◽

Developing Countries ◽

Early Detection ◽

Evaluation Studies ◽

The United States ◽

Drug Reactions ◽

Prescription Monitoring ◽

Concurrent Use ◽

United States Food ◽

States Food

Gabapentin and pregabalin, commonly known as gabapentinoids, have been widely used globally. This paper highlights the serious breathing problems due to using gabapentin and pregabalin which was warned by the United States Food and Drug Administration on December, 2019. In this article, we tried to recommend suggestions for controlling these adverse drug reactions (ADRs). Safety reports of gabapentin and pregabalin should be obtained from concerned manufacturers and reviewed for respiratory depression effects. There should be strict prescription monitoring and drug use evaluation studies. Concurrent use of gabapentin and pregabalin with other respiratory depressants should be strictly monitored. Educating patients can help in the early detection of ADRs due to gabapentin and pregabalin. Anecdotal reports on these medications should be encouraged.

Download Full-text