New warning labels for Opioids: On Tuesday, the U.S. FDA issued a safety announcement on the use of opioids based medications. About 18 different types of opioid medications exist in the U.S. market. The FDA has declared the entire class of opioid pain medicines unsafe in some conditions and is asking all opioid manufacturers to revise their warning labels on such drugs.

Opioids are a class of prescription medicine which relieve pain but can also lead to addiction. According to the American Society of Addiction Medicine (ASAM), opioid addiction is one of the leading causes of death in the United States.

In 2012, about 259 million prescriptions were given for opioid drugs and in 2014 opioid overdose caused around 18,893 deaths in the U.S., making opioid addiction an epidemic. The ASAM further states 23% of heroin addicts also develop opioid addiction.

According to the FDA, even prescription opioids can interact with other drugs in a harmful way and lead to numerous critical conditions. The announcement is a warning listing the potential risks linked with taking opioid medication.

Opioids cause three main health problems. Opioids interact with antidepressants and migraine medicines, also known as serotonergic medicines, leading to the serotonin syndrome. The serotonin syndrome is a serious central nervous system condition in which high levels of chemical serotonin start storing in the brain. The levels reach such a high amount it causes toxicity in the brain.

Another rare condition caused by opioids is in the adrenal glands. Opioids disturb the production of the hormone cortisol in the gland which is responsible for handling stress in the body. Similarly, the long-term use of opioids decreases levels of sex hormones, leading to lessened sexual drive, impotence and even infertility in some cases.

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So under FDA all opioid med packages need to feature warnings and additional information, about the serotonin syndrome, adrenal insufficiency and decrease in sex hormone levels.

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What Are Opioids?

Opioids can be described as a class of very powerful pain relieving narcotics, used for treatment of moderate to severe pain. Opioids are prescribed when other pain relieving medicines fail to do the job, but opioids can prove to be very addictive if misused. Abuse of opioids can lead to addiction, overdose and even death, making it an epidemic in the U.S.

There are two main categories of opioid medicines: IR products and ER/LA products. The Immediate-Release (IR) products are prescribed to be taken every 4 to 6 hours. The Extended Release/Long Acting (ER/LA) products are prescribed to be taken only once or twice a day.

The dosage also varies depending on the types of products and patients. They are available in many different forms such as tablets, capsules, patches, sprays and even injections. Some normal side effects of opioids are nausea, constipation, vomiting, dizziness, drowsiness and difficulty in breathing.

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New Warning Labels For Opioids — The Medicines Under FDA Review

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  • Alfentanil
  • Buprenorphine
  • Butorphanol
  • Codeine
  • Dihydrocodeine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Meperidine
  • Methadone
  • Morphine
  • Contin
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Remifentanil
  • Sufentanil
  • Tapentadol
  • Tramadol

The variants of Oxycodone (OxyContin) and Hydrocodone (Vicodin) are the most prevalent drugs used by addicted high schoolers in the U.S. In 2015, it was found 4.4% of 12th graders were addicted to Vicodin, while 3.7% were addicted to OxyContin.

Certain opioid forms like methadone and buprenorphine can also be used to treat opioid addiction. The FDA suggests people with a family history of addiction or mental illness should not use opioids.

Serotonin Syndrome

Serotonin syndrome, also known as serotonin toxicity, occurs when opioids are mixed with serotonergic medicines. The symptoms of the syndrome include fever, excessive sweating, shivering, muscle twitching, agitation, hallucinations, increased heart rate, nausea, vomiting, and diarrhea. The symptoms appear usually after a few hours of taking both drugs or may even take up to a few days.

The FDA recommends immediate medical attention if a person takes both the drugs at the same time. Discontinuation of both medications is recommended in such a case.

A survey by the FDA found out that since 1969 until 2013, about 43 cases of serotonin syndrome developed due to opioids use with serotonergic drugs. Especially fentanyl, oxycodone, and methadone increased the risk of developing the syndrome.

Some different types of serotonergic medicines are:

  • Selective Serotonin Reuptake Inhibitors (SSRIs)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
  • Tricyclic Antidepressants (TCAs)
  • Monoamine Oxidase Inhibitors (MAOIs)
  • Other Psychiatric Medicines
  • Migraine Medicines
  • Antiemetics

Adrenal Insufficiency

Adrenal insufficiency occurs when opioids disturb the normal cortisol production ability of the adrenal gland. The symptoms include nausea, vomiting, loss of appetite, fatigue, weakness and dizziness. The FDA recommends treating affected patients with corticosteroids.

The FDA also identified 37 cases of adrenal insufficiency due to use of opioids from 1969 up till 2014. Most commonly, the use of fentanyl, oxycodone, buprenorphine, naloxone, hydromorphone and tramadol caused adrenal insufficiency.

Sex Hormones (Androgen) Deficiency

Androgen deficiency is a condition in which the body does not create adequate amounts of sex hormones also called androgens e.g., testosterone and oestrogen. The FDA has carried out studies which show the long-term use of opioids leads to decrease in levels of the sex hormones.

Opioid-induced androgen deficiency is mostly seen in chronic users of opioids i.e., addicts. In both men and women, the continued use of opioids can lead to reduced libido and ultimately even infertility. In men, the use of opioids can even lead to impotence. According to the FDA, individuals using opioids and experiencing such symptoms should undergo laboratory evaluation.

The FDA recommends patients with chronic pain should carefully read the leaflets provided with their prescribed opioid medication to avoid any further complications.