FDA Date: 3/21/16
Opioid Pain Medicines FDA Drug Safety Communication
FDA warns about several safety issues with opioid pain medicines; requires label changes
The U.S. Food and Drug Administration (FDA) is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.
- Opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity.
- Taking opioids may lead to a rare, but serious condition in which the adrenal glands do not produce adequate amounts of the hormone cortisol. Cortisol helps the body respond to stress.
- Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as reduced interest in sex, impotence, or infertility.
Opioids are a class of powerful narcotic pain medicines that are used to treat moderate to severe pain that may not respond well to other pain medicines. They can help manage pain when other treatments and medicines are not able to provide enough pain relief, but they also have serious risks including misuse and abuse, addiction, overdose, and death.
Recommendations and information for patients and health care professionals
Patients taking an opioid along with a serotonergic medicine should seek medical attention immediately if they develop symptoms such as agitation; hallucinations; rapid heart rate; fever; excessive sweating; shivering or shaking; muscle twitching or stiffness; trouble with coordination; and/or nausea, vomiting, or diarrhea. Symptoms generally start within several hours to a few days of taking an opioid with another medicine that increases the effects of serotonin in the brain, but symptoms may occur later, particularly after a dose increase.
Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.
Cases of serotonin syndrome in the FDA Adverse Event Reporting System (FAERS) database were reported more frequently with the opioids fentanyl and methadone used at the recommended doses. Therefore, we are requiring a new statement in the Warnings and Precautions section to be added to these drug labels. Some opioids, including tramadol, tapentadol, and meperidine, already have warnings about serotonin syndrome. Cases were also reported with other opioids, so the labels of all these drugs will be updated to include information about serotonin syndrome in the Drug Interactions and Adverse Reactions sections.
Patients should seek medical attention if they experience symptoms of adrenal insufficiency such as nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure. Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.
We are requiring a new statement about adrenal insufficiency to be added to the Warnings and Precautions section of all opioid labels.
Decreased sex hormone levels:
Patients should inform their health care professionals if they experience symptoms of low libido, impotence, erectile dysfunction, lack of menstruation, or infertility. Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.
We reviewed published studies that assessed levels of sex hormones in patients taking opioids chronically; however, all had limitations that make it difficult to determine whether the symptoms were caused by the opioids or other factors. The labels of some opioids already describe this possible risk, and we are now adding consistent information to the Adverse Reactions section of all opioid labels.
"Kama ilivyoelezwa katika taarifa ya FDA ya Usalama wa Dawa ya Ugonjwa wa Opioid, FDA inatoa onyo juu ya ""matatizo kadhaa ya usalama na dawa za maumivu ya opioid"" na ""inahitaji mabadiliko ya lebo"" na ""Usimamizi wa Chakula na Dawa wa Marekani (FDA) inatoa onyo juu ya masuala kadhaa ya usalama na darasa lote la dawa za maumivu ya opioid.""" Hatari hizi za usalama ni mwingiliano wenye kudhuru na dawa nyingine nyingi, matatizo na tezi za adrenal, na kupungua kwa viwango vya homoni za ngono. "Tunahitaji mabadiliko katika lebo za dawa zote za opioid kuonya juu ya hatari hizi. """ Dawa za opioid zinaweza kuingiliana na dawa za antidepressants na dawa za kipandauso na kusababisha athari mbaya ya mfumo wa neva wa kati inayoitwa serotonin syndrome, ambayo viwango vya juu vya serotonin ya kemikali hujikusanya katika ubongo na kusababisha sumu. - Kutumia opioids inaweza kusababisha hali nadra, lakini mbaya ambayo tezi za adrenal hazitokezi kiasi cha kutosha cha homoni cortisol. Cortisol husaidia mwili kujibu mkazo. - Matumizi ya muda mrefu ya opioids yanaweza kuhusishwa na kupungua kwa viwango vya homoni za ngono na dalili kama vile kupungua kwa nia ya ngono, ukosefu wa uwezo wa ngono, au utasa. Opioids ni aina ya dawa za kulevya zenye nguvu za maumivu ambazo hutumiwa kutibu maumivu ya wastani hadi kali ambayo hayawezi kujibu vizuri kwa dawa zingine za maumivu. Dawa hizo zinaweza kusaidia kudhibiti maumivu wakati matibabu mengine na dawa hazina uwezo wa kutoa misaada ya kutosha ya maumivu, lakini pia zina hatari kubwa ikiwa ni pamoja na matumizi mabaya na unyanyasaji, ulevi, overdose, na kifo. Matibabu ya matibabu ya opioid na serotonergic ya matibabu ya serotonergic ya opioid ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic ya serotonergic. Kwa kawaida dalili huanza ndani ya masaa kadhaa hadi siku chache baada ya kuchukua opioid na dawa nyingine ambayo huongeza athari za serotonini kwenye ubongo, lakini dalili zinaweza kutokea baadaye, haswa baada ya kuongezeka kwa kipimo. Wataalamu wa huduma za afya wanapaswa kuacha matibabu ya opioid na / au matumizi ya dawa nyingine ikiwa kuna shaka ya ugonjwa wa serotonini. Katika mfumo wa ripoti ya FDA ya matukio mabaya (FAERS), kesi za ugonjwa wa serotonin ziliripotiwa mara nyingi zaidi na opioids fentanyl na methadone zilizotumiwa kwa kipimo kilichopendekezwa. Kwa hivyo, tunahitaji taarifa mpya katika sehemu ya Maonyo na U tahadhari kuongezwa kwenye lebo hizi za dawa. Dawa fulani za kulevya, kutia ndani tramadol, tapentadol, na meperidine, tayari zina maonyo kuhusu ugonjwa wa serotonini. "Kama ilivyoelezwa hapo juu, dawa za opioid zinapaswa kuwa na ""maelezo ya juu"" ya madawa ya kulevya, ambayo inapaswa kujumuisha habari kuhusu ugonjwa wa serotonini katika sehemu za ""Mingiliano ya Dawa"" na ""Madhara.""" Wagonjwa wanapaswa kutafuta matibabu ikiwa wanapata dalili za upungufu wa adrenal kama vile kichefuchefu, kutapika, kupoteza hamu ya kula, uchovu, udhaifu, kizunguzungu, au shinikizo la chini la damu. Wataalamu wa huduma za afya wanapaswa kufanya uchunguzi wa utambuzi ikiwa kuna shaka ya upungufu wa adrenal. Ikiwa imegunduliwa, kutibu na corticosteroids na kumzuia mgonjwa kutoka kwa opioid, ikiwa inafaa. Ikiwa opioid inaweza kusimamishwa, tathmini ya kufuatilia ya kazi ya adrenal inapaswa kufanywa ili kuamua kama matibabu na corticosteroids yanaweza kusimamishwa. "Hii ni kwa sababu ya taarifa mpya kuhusu upungufu wa adrenal ambayo inapaswa kuongezwa kwa ""Maonyo na tahadhari"" sehemu ya lebo zote za opioid." Ugonjwa wa homoni za ngono: Wagonjwa wanapaswa kuwajulisha wataalamu wao wa huduma za afya ikiwa wanapata dalili za libido ya chini, ukosefu wa nguvu, dysfunction ya erectile, ukosefu wa hedhi, au utasa. Wataalamu wa huduma za afya wanapaswa kufanya tathmini ya maabara kwa wagonjwa wanaosababisha dalili au dalili kama hizo. "Tuliangalia masomo yaliyochapishwa ambayo yalikadiria viwango vya homoni za ngono kwa wagonjwa wanaotumia opioids kwa muda mrefu, lakini yote yalikuwa na mapungufu ambayo hufanya iwe vigumu kuamua ikiwa dalili zilitokana na opioids au sababu nyingine. """ "Hii ni kwa sababu ya kwamba maandiko ya dawa za kulevya yanaonyesha hatari ya kuambukizwa na ""madhara"" na sasa tunaongeza habari ya kawaida kwenye sehemu ya athari mbaya ya maandiko ya dawa zote za kulevya."