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FDA Approves Lusedra

-December  19, 2008

Earlier this week, the Food and Drug Administration (FDA) approved a new sedative-hypnotic agent that will be distributed under the brand name Lusedra. A sedative-hypnotic agent is any type of medication that calms patients and induces light sleep by depressing the central nervous system.

Currently, the FDA is recommending that the U.S. Drug Enforcement Administration (DEA) classify Lusedra as a "controlled substance," meaning that the drug will be illegal outside of specific, expert-monitored environments.

While the FDA and Eisai (Lusedra's manufacturer) await the DEA's decision, as soon as the DEA's report is published, Lusedra's label will be updated, and the drug will be available for widespread use.

Lusedra's Uses

As a sedative-hypnotic agent, Lusedra is indicated for use in monitored anesthesia care (MAC) - as opposed to local, general or regional anesthesia. MAC involves sedating a patient without fully knocking him unconscious. This means that patients under MAC will be in a light sleep stage so that they are still responsive and will be able to breathe on their own.

In most cases, Lusedra will be used as an adjunct to local and/or regional anesthesia, which will typically occur during minor surgery when patients need further help:

• getting more comfortable
• reducing their anxiety
• relieving their pain

Only professional anesthesiologists (or others specifically trained to administer anesthesia) are permitted by law to give patients Lusedra.

While patients who receive Lusedra may awake during their procedure, as the medication only puts them in a light sleep, they will have no memory of doing so.

By the end of the procedure, most patients will naturally awake from the effects of Lusedra and, following an evaluation, will be able to go home.

Known Side Effects of Lusedra

Like many newly approved FDA prescriptions, Lusedra does carry the possibility of some side effects, which may include:

• hypotension, dangerously low blood sugar
• hypoxemia, low blood-oxygen levels
• lowered responsiveness, as some patients will lose their ability to respond to pain when under the influence of Lusedra
• respiratory depression, which may mean that some patients will need assistance breathing when under the influence of Lusedra
• sensations of burning, tingling and/or sensitive skin (paresthesia)
• severe itchiness (pruritis)

Paresthesia and pruritis are the most commonly reported side effects of Lusedra.

(Source: Sources: Medical News)

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