Isotretinoin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Isotretinoin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
CONTRAINDICATIONS AND WARNINGS Isotretinoin capsules must not be used by patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin capsules exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a patient who is taking isotre
WARNINGS Psychiatric Disorders Isotretinoin capsules may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.
No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric ).
Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin.
Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need.
Therefore, prior to initiation of isotretinoin capsules therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary.
Signs and symptoms of depression, as described in the brochure ("Recognizing Psychiatric Disorders in Adolescents and Young Adults"), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment.
Patients should stop isotretinoin capsules and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit.
Discontinuation of isotretinoin capsules therapy may be insufficient; further evaluation may be necessary.
While such monitoring may be helpful, it may not detect all patients at risk.
Patients may report mental health problems or family history of psychiatric disorders.
These reports should be discussed with the patient and/or the patient's family.
A referral to a mental health professional may be necessary.
The physician should consider whether isotretinoin capsules therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of isotretinoin capsules therapy.
Pseudotumor Cerebri Isotretinoin capsules use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
Concomitant treatment with tetracyclines should therefore be avoided.
Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances.
Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue isotretinoin capsules immediately and be referred to a neurologist for further diagnosis and care (see ADVERSE REACTIONS: Neurological ).
Serious Skin Reactions There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use.
These events may be serious and result in death, life-threatening events, hospitalization, or disability.
Patients should be monitored closely for severe skin reactions, and discontinuation of isotretinoin capsules should be considered if warranted.
Pancreatitis Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels.
In rare instances, fatal hemorrhagic pancreatitis has been reported.
Isotretinoin capsules should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.
Lipids Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with isotretinoin capsules.
Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving isotretinoin capsules in clinical trials.
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