FDA Requires New Warning on Opioid Pain Medications

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The FDA has issued a new required warning for all opioid pain medications. If you are taking an opioid, you should be aware of a few potential side effects, including reactions with other medications, and effects on hormone levels.

What are some examples of opioid medications?

Opioids are powerful prescription-only medications, used to manage manage pain when other treatments may not work. Some common opiods include:

Why exactly was the FDA safety alert issued?

The FDA identified some safety concerns for anyone using opioid pain medications:

What kind of medications can react with opioids?

Specifically, opioids may react with antidepressants and migraine medications. When used with opioids, these medications may cause a serious, life-threatening condition known as serotonin syndrome.

Serotonin syndrome is the accumulation of too much serotonin (a naturally occurring chemical in the brain responsible for mood). Symptoms may include increased blood pressure, fast heartbeat, increased body temperature, nausea, vomiting, diarrhea, and restlessness.

Examples of antidepressants that may be affected include Zoloft (sertraline), Celexa (citalopram), Effexor (venlafaxine), Cymbalta (duloxetine), and trazodone.

Migraine medications that may be affected include Imitrex (sumatriptan), Maxalt (rizatriptan), and Zomig (zolmitriptan).

How can opioids affect my adrenal glands?

Taking an opioid can also lead the a rare but serious condition where your adrenal glands don’t produce enough of the hormone cortisol. Symptoms include nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.

Cortisol is the hormone responsible for the regulation of a wide variety of processes throughout the body including metabolism and immune response. Cortisol is best known for its role in helping the body respond to stress.

Why would a decrease in sex hormones be a concern?

A decrease in sex hormones can be associated with loss of sexual desire, inability to get and keep an erection, lack of menstruation, and infertility.

While these symptoms are not life threatening like serotonin syndrome or adrenal insufficiency, they can still drastically affect your quality of life.

What is the FDA doing in response to the new concerns?

The FDA is requiring changes to the labeling of all opioid medications to make sure you and your doctor are aware of the risks.

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