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Current Label warnings for Roaccutane / Accutane. US - August, 2005 see FDA website under psychiatric disorders the current label warnings states: "Accutane 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. 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 initation of Accutane 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. Signs and symptoms of depression, as described in the brochure (Recognising Psychiatric Disorders in Adolescents and Young Adults) accutane hearing loss include sad mood, hopelessness, feelings accutane hearing loss of guilt, worthlessness or helplessness, loss of pleasure or interests in activities, fatigue, difficulty in concentrating, change in sleep pattern, change. Patients should stop Accutane and the patient or a accutane hearing loss family member should promplty contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Accutane therapy may be insufficent; 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 physican should consider whether Accutane therapy is appropiate in this setting; for some patients the risks may outweigh the benefits of Accutane therapy. EU Warnings, roaccutane was registered in all EU Member States, except Sweden, from 1983. The emea (European Agency for the Evalation of Medicinal Products) was established in 1995 which provided a centralised and mutual recognition procedure for authorising medicinal products. However as Roaccutane was not approved by the EU central authorisation system it remained the responsibility of national authorties to take more restrictive measures if necessary. However, it could be referred to the emea for an opinoin at the request of a competent authority if there was evidence of new and unexpected risks. On, France requested accutane hearing loss a referral of Roaccutane due to the fact that Roaccutane did not have the same summary of product characteristics across Member States due to divergent national decisions. An amended summary of product characteristics was approved in October 1993. Emea website ireland:- s ee ipha website july 2004, under psychiatric disorders the summary of product characteristics (SPC) states: "Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, accutane hearing loss and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of isotretinoin may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary.". The Patient Information Leaflet (PIL) states: - "Rare cases of depression, worsening depression, anxiety, mood changes, psychotic symptoms and very rarely suicidal thoughts, suicide attempts and suicide have been observed. If you have any kind of mental problems, or, if you observe signs of depression while taking Roaccutane such as feeling very sad for no reason, crying spells, difficulty concentrating or you become withdrawn from your friends or family, please inform your doctor. Your doctor may refer you for appropiate treatment if necessary. Discontinuation of your Roaccutane therapy may not be sufficent to alleviate symptoms and you may require further psychiatric or psychological evaluation. There have been reports of patients on Roaccutane becoming violent or aggressive. UK:- see EMC website) - Similar warnings to Ireland, above. Top, uS Historical Warning 1971, hoffman La-Roche (Roche) develops Accutane, but chooses not to pursue marketing because of its risk of birth accutane hearing loss defects. June 1982, the Food and Drug Administration (FDA) approves Accutane for the treatment of severe cystic acne which is unresponsive to other treatments. Shortly after marketing, FDA and Roche receive reports of Accutane-related birth defects. September 1983, public Citizen, a consumer advocacy group, petitions FDA for warning labels on Accutane's risk of birth defects and other side effects. March and October 1984. FDA requires stronger warnings and physician mailings on Accutane's risk of birth defects. June 1985 * depression added TO THE label warning. Roche amends Accutane's package insert under 'Adverse Reactions' to state: "The following CNS reactions have been reported and may bear no relationship to therapy - seizures, emotional instability including depression, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy and paresthesias.". August 1986, roche amends Accutane's package insert to state: "Depression has been reported in some patients on Accutane therapy.

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Isotretinoin, more commonly known by the former brand name. Accutane, is a powerful systemic drug used to treat severe inflammatory acne. Isotretinoin is classified as a retinoid, made from a synthetic form of accutane acne.org vitamin. It is taken orally, in pill form, once or twice daily. Accutane has accutane acne.org become one of the most accutane acne.org effective treatments available for patients with severe or cystic acne, successful even for patients whose acne has not responded to other treatments. According to the American Academy of Dermatology, isotretinoin is considered the most effective prescription treatment available for severe acne. It is generally believed to successfully treat and eliminate severe acne in about half of those who take. A Last Resort for Severe Acne. The decision to begin taking Accutane or another isotretinoin product is something you must discuss with your dermatologist. Because of its potency and possible side effects, the medication is reserved only for those with severe inflammatory or cystic acne that has failed to respond to other treatment options. All patients taking an isotretinoin-based drug are kept under careful monitoring by their accutane acne.org doctors. Prior to June 2009 when it was discontinued, isotretinoin was primarily sold as Accutane though it has been available as a generic drug since 2002. . Isotretinoin is now sold under the brand names Amnesteem, Claravis, and Sotret. How Isotretinoin Works, isotretinoin works by shrinking the sebaceous glands within the dermis, accutane acne.org reducing the amount of oil produced. The exact mechanism accutane acne.org of this is still unknown. The reduction of oil within the follicle accutane acne.org means less clogging of the pores, leading to a reduction of overall acne breakouts. Common Course of Treatment, the most common treatment process consists of a 16- to 20-week course followed by a period of rest. More courses are then prescribed if sufficient clearing is not achieved. For the majority of patients, one course is all that is needed. Approximately 20 percent of patients require a second course. To avoid a relapse, patients must finish the prescribed course, even if the skin becomes clear before all the pills have been taken. During treatment, patients are closely monitored by their doctors. Patients are required to schedule regular follow-up appointments and submit to blood testing to check for possible side effects, such as liver damage and an increase in triglycerides in the blood. While isotretinoin is a valuable treatment for those with severe acne, it is not without side effects. The most serious side effects of this drug are miscarriage among pregnant women accutane acne.org and severe birth defects in babies whose mothers took the medication while pregnant. Food and Drug Administration requires women not be pregnant or become pregnant during isotretinoin use. All women who are of childbearing age are required to take two pregnancy tests prior to beginning isotretinoin treatments. The FDA also requires women to use two forms of birth control for one month prior to treatment, during treatment, and for one month after treatment ends.

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