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The REMS program is required if it is determined that specific safety measures are needed to ensure that a drugs benefits outweigh the risks, either during the initial product review or at any point in the post-marketing period.
Drugs that block monoamine reuptake initially suppress rapid eye movement (REM) sleep in the cat and other species. Less is known about the effects of repeated drugs administration.
Rapid eye movement (REM) sleep is the stage of sleep where most dreams happen. Its name comes from how your eyes move behind your eyelids while youre dreaming. During REM sleep, your brain activity looks very similar to brain activity while youre awake. REM sleep makes up about 25% of your total time asleep.
The most common role(s) of each of the key participants in the Risk Evaluation and Mitigation Strategy (REMS) (e.g., patients, health care providers, pharmacists and health care settings that dispense or administer the drug) are further described below.
The FDA requires a REMS program for about 70 drugs. In six of these cases, the REMS covers an entire class of drugs (shared REMS). About half of currently approved REMS programs include Elements to Assure Safe Use (ETASU).
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The Food and Drug Administration (FDA) has the authority to require a REMS as part of product approval as well as at any time after approval, and to require the inclusion of specific elements to assure safe use.
The branded and generic drug products subject to this REMS include all the following: Oral dosage forms containing: codeine and codeine analogs, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, oxycodone, oxymorphone, pentazocine, tapentadol, tramadol. Intranasal butorphanol.
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs.

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