Discussion 2.1: Medication Safety and Drug Approvals
Directions

Review the U. S. Food and Drug Administration website (https://www.fda.gov) . Review the drugs section of the website.

First, select the Menu button at the top of the screen.

In the Featured column, choose the Recalls, Market Withdrawals and Safety Alerts tab.

Review recalls and alerts and choose one to discuss for your initial post.

In your initial post, pose a question on how a nurse practitioner could protect a client from being harmed by the medication. This must be a question that is posed for your classmates to answer. Do not answer this question in your initial post.

After reviewing the recalls and alerts, select the Menu button.

From the Products heading, select Drugs. Go to the navigate the drugs section and select the Updates, News, Events, and Training link. This
will take you to information about new drugs approved by the FDA.

In your initial post, describe the newly-approved drug you selected, including its indications/uses and mechanism(s) of action. This part of your initial post should be about a brand-new drug or a new indication for a drug.
Post your original response by the end of Day 3. Then, by the end of Day 6, respond to at least two of your classmates’ posts.
If you copy and paste references from the course into your assignment, be sure to confirm current APA professional paper formatting (https://lmscontent.embanet.com/MVU/Syllabus/APA_Style.html) before
submitting.

SAMPLE ANSWER

SYMJEPI (epinephrine) Injection is one of the drugs recalled by the FDA. Kindly state the reason why the drug was recalled and why it is a concern to patient safety.

KEPPRA

KEPPRA, whose active ingredient is Levetiracetam, is one of the drugs recently approved by the FDA. The drug comes as a tablet or in suspension form. From the filed documents in the FDA portal, the drug is used to treat myoclonic seizures in persons 12 years and above with juvenile myoclonic epilepsy, persons six years and above who have primary generalized tonic-clonic seizures with certain types of generalized epilepsy, and for treatment of partial-onset seizures for children, 1-month or older (FDA, 2023).

One of the causes of seizures is the excessive release of glutamate. Glutamate is an excitatory neurotransmitter that has several types of receptors throughout the central nervous system. It plays an important role in memory, mood regulation, and cognition, but, at the same time, responsible for seizures and other neurologic disorders like Alzheimer’s when the levels are too high (Sarlo & Holton, 2021). The mechanism of action for KEPPRA, whose main ingredient is Levetiracetam, involves the modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain (Contreras-García et al., 2022). By binding to the synaptic vesicle protein, KEPPRA inhibits the release of glutamate, thus maintaining its level low enough to prevent the occurrence of seizures.

References

Contreras-García, I. J., Cárdenas-Rodríguez, N., Romo-Mancillas, A., Bandala, C., Zamudio, S. R., Gómez-Manzo, S., Hernández-Ochoa, B., Mendoza-Torreblanca, J. G., & Pichardo-Macías, L. A. (2022). Levetiracetam mechanisms of action: from molecules to systems. Pharmaceuticals, 15(4), 475. https://doi.org/10.3390/ph15040475

Sarlo, G. L., & Holton, K. F. (2021). Brain concentrations of glutamate and GABA in human epilepsy: A review. Seizure, 91, 213-227. https://doi.org/10.1016/j.seizure.2021.06.028

United States Food and Drug Administration [FDA]. (2023). FDA-approved drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s113,021505s052lbl.pdf#page=32