The Food and Drug Administration (FDA) and dermatology organizations need to do a better job of warning consumers about the link between Accutane, a commonly prescribed acne drug, and depression or suicide, members of a US Congressional committee have said. Their comments come following a recent congressional hearing exploring the link.
"The FDA is supposed to guarantee the efficacy of drugs for the people of this country," said Rep. Dan Burton (R-Ill.), chairman of the House Committee on Government Reform. "To say that it's too difficult to do it is kind of a cop-out."
Rep. Burton also blasted the American Academy of Dermatology for not notifying all of its members of Accutane's mental health risks.
"Why not send a fax out to all your members saying, 'This is a risk, and we want to make sure you know about it'? If the academy doesn't do it, give me a list of all your members and I'll send the darned thing out."
Since 1982, when Accutane was first introduced, the government has received 66 reports of patients who committed suicide while taking the drug. Of course, underreporting of incidents in almost certain.
Patients who take the drug will soon get special warning brochures outlining side effects - including the possible, but not proven, link to suicide. Patients must then sign a paper certifying they understand those risks, Dr. Jonca Bull, the FDA's deputy drug chief told Congress.
Also, the FDA is developing tougher restrictions on who can take Accutane and which doctors can prescribe it, Dr. Bull told the committee. This so-called registry is an attempt to counter another Accutane problem: 2,000 women have gotten pregnant while taking Accutane since the drug began selling in 1982. Accutane causes severe birth defects. The registry could be in place ``as early as next summer,'' Bull said.
The committee heard from several families about their experiences with Accutane. Seventeen-year-old Amanda Calais of Denham Springs, Louisiana, described how she began feeling depressed only a few weeks after starting the drug. "I found myself feeling sad, and I often cried for no reason," she said. Calais later attempted suicide. She claims her depression lifted after she stopped using the drug.
The committee also heard from several other parents whose children had committed suicide while taking Accutane. All of the parents said they had received no warnings about a possible link between Accutane and depression either from their physician or their pharmacist.
James O'Donnell PharmD, Assistant Professor of Pharmacology, Rush Medical College, Chicago testified about the pharmacological aspects of the drug and possible mechanisms by which Accutane may have adverse psychological effects. He states:
"it is associated with a long list of side-effects which are frequent, varied and at times severe. The most commonly occurring adverse reactions are those involving the skin and mucous membranes, which occur in all patients treated with Accutane. Other side effects reported include skin fragility, pyogenic granuloma-like lesions and epidermal blistering, paronychia and alopecia (Bigby, 1988). Gastrointestinal intolerance occurs in 20% of patients treated (Bigby, 1988). Muscular or joint pain, are quite common with Accutane use. Myalgia and arthralgias occur in 16% of patients treated, which usually abate when the medication is discontinued (Orfanos, 1997).
Blepharitis and conjunctivitis associated with Accutane use were recognized well before its marketing. Corneal opacities and acute myopia have been reported in government publications and in the ophthalmologic literature. Other ocular reactions include optic neuritis, cataracts, decreased night vision, blurred vision and photosensitivity. Pseudotumor cerebri (PTC) and headaches are also associated with the drug. In common with other retinoids at pharmacological doses, Accutane causes elevation of serum lipids particularly triglycerides.
Chronic hypervitaminosis A is more common than the acute form and results from continued ingestion of high doses [of vitamin A] for months or even years. Symptoms include anorexia, dry itchy skin, alopecia, increased intracranial pressure, fatigue, irritability, somnolence pronounced craniotabes and occipital edema, skin desquamation, fissuring of the lips, pain in the legs and forearms, neurologic disturbances and lethargy. Elevated blood lipids are also common.(Wilson, 1996 ) This reads just like the Accutane package insert.
Concerning the possible effects of Accutane on psychiatric function, Dr. O'Donnell states:
Vitamin A intoxication resulting in generalized as well as Central Nervous System (CNS) symptoms, was first alluded to in 1856 by Elisha Kane (Kane, 1856), the arctic explorer. He recorded symptoms of vertigo, headache, drowsiness and irritability following ingestion of polar bear liver, which was later found to contain a high concentration of vitamin A. Over the succeeding 140 years, case reports of the occurrence of acute schizophrenia or remitting psychosis associated with either hypervitaminosis A (Halter, 1991; Haupt, 1977; Landy, 1985) or vitamin A deficiency (Oliver, 1986) have appeared in the literature. These provide literature precedent and biologic plausibility to the causation analysis. In 1972, Restak reported a case of toxic psychosis in a patient following vitamin A treatment (50,000 IU 2/3 times daily) for acne, which required hospitalization. About six months after initiating vitamin A therapy, the patient experienced the onset of prolonged depression, bouts of elation alternated with despondency, disturbed sleep, insomnia and loss of appetite. Twelve months later, while on holidays, she became more agitated and depressed, and lost weight. She also developed blurred vision, hyperacusis, vertigo, strong feelings of ego alienation, and lethargy. Following psychiatric referral, total remission occurred over 6 months of close observation and anti-depressant therapy. The authors cautioned against the use of the vitamins as preventatives for such benign entities as acne. (Middelkoop, 2000) In 1992, a case report described a patient, with no previous psychiatric history, who presented with a 1-year history of depressed mood and poor concentration (McCance-Katz, 1992). Medication included only a multivitamin preparation of 25,000 IU of vitamin A per day, for 2 years. Hamilton Depression Ratings confirmed full cessation of depressive symptoms after stopping treatment. Other reports of lethargy, loss of interest in surroundings, insomnia, listlessness, profound daily fatigue, anorexia and irritability, in association with vitamin A, have been documented (Stimson, 1961; Shaw, 1953; Oliver, 1958; Bifulco, 1957; Elliot, 1965).
Vitamin A intoxication resulting in generalized as well as Central Nervous System (CNS) symptoms, was first alluded to in 1856 by Elisha Kane (Kane, 1856), the arctic explorer. He recorded symptoms of vertigo, headache, drowsiness and irritability following ingestion of polar bear liver, which was later found to contain a high concentration of vitamin A. Over the succeeding 140 years, case reports of the occurrence of acute schizophrenia or remitting psychosis associated with either hypervitaminosis A (Halter, 1991; Haupt, 1977; Landy, 1985) or vitamin A deficiency (Oliver, 1986) have appeared in the literature. These provide literature precedent and biologic plausibility to the causation analysis.
In 1972, Restak reported a case of toxic psychosis in a patient following vitamin A treatment (50,000 IU 2/3 times daily) for acne, which required hospitalization. About six months after initiating vitamin A therapy, the patient experienced the onset of prolonged depression, bouts of elation alternated with despondency, disturbed sleep, insomnia and loss of appetite.
Twelve months later, while on holidays, she became more agitated and depressed, and lost weight. She also developed blurred vision, hyperacusis, vertigo, strong feelings of ego alienation, and lethargy. Following psychiatric referral, total remission occurred over 6 months of close observation and anti-depressant therapy. The authors cautioned against the use of the vitamins as preventatives for such benign entities as acne. (Middelkoop, 2000)
In 1992, a case report described a patient, with no previous psychiatric history, who presented with a 1-year history of depressed mood and poor concentration (McCance-Katz, 1992). Medication included only a multivitamin preparation of 25,000 IU of vitamin A per day, for 2 years. Hamilton Depression Ratings confirmed full cessation of depressive symptoms after stopping treatment.
Other reports of lethargy, loss of interest in surroundings, insomnia, listlessness, profound daily fatigue, anorexia and irritability, in association with vitamin A, have been documented (Stimson, 1961; Shaw, 1953; Oliver, 1958; Bifulco, 1957; Elliot, 1965).
Depression has been listed as a possible side effect on Accutane's label since 1986, and the FDA in 1998 strengthened the warning to say suicide, too, was possible. The suicide link gained wide attention in October when a Michigan congressman, Democrat Bart Stupak, blamed his 17-year-old son's suicide on Accutane - and charged that patients and families aren't warned about the risk, which appears in the fine print of drug labels that many consumers never receive.
Accutane is not the miracle cure-all for acne that it is promoted to be. It has a category X for pregnancy which means that it causes birth defects in nearly 100% of pregnant women.
The key to eliminating acne is to stop all soft drinks, juice, and milk and to drink one quart of pure water for every fifty pounds of body weight. It is also necessary to eliminate ALL sugar and chocolate. This strategy works in the majority of people, but some have elevated testosterone levels, which can promote acne.
In this case, non-synthetic vitamin A (the real McCoy-my favorite is emulsified vitamin A from Biotics Research) is very helpful. It is likely not toxic in pregnancy, but nonetheless should be avoided. To be effective one must use a high dose of 100-200,000 IU per day. The dose should not be used for longer than several months as toxicity could be an issue (as detailed above) if taken much longer.
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