Skin Diseases/ Injuries from Accutane
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on a voluntary basis. In other words, the doctor, hospital, or other medical person or facility are not required by law to report an adverse side effect from a drug. The FDA reported that perhaps only one in one hundred side effects ever get reported. One could only imagine about how many serious Adverse Side Effects there are from taking Accutane, that have never been reported to anyone!
Under Federal Law, the manufacturer of a drug is required to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.
The FDA has required Hoffmann-La Roche to revise its label for Accutane many times. The most recent label states - ...Many of the side effects and adverse reactions seen in patients receiving Accutane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, et, of the lips, nasal passage, and eyes.
Skin and Appendages: acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), sunburn susceptibility increased, sweating, urticaria, vasculitis (including Wegener's granulomatosis: see PRECAUTIONS: Hypersensitivity), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PRECAUTIONS: Information for Patients and Prescribers)
FDA - Accutane Information Page
Hoffmann-La Roche down-plays the side effects of Accutane by talking about its effect on the skin. They readily admit that it causes skin diseases and/or injuries. Following are just a few of those skin and appendages side effects.
Acne Fulminans
Acne fulminans is a rare and very severe form of acne conglobata associated with systemic symptoms. It nearly always affects males. It is characterized by:
Abrupt onset
Inflammatory and ulcerated nodular acne on chest and back
Severe acne scarring
Fluctuating fever
Painful joints
Malaise (i.e. the patient feels unwell)
Loss of appetite and weight loss
Raised while blood cell count
One source of additional information is DermNet
Alopecia
(Hair Loss - Sometimes Permanent)
Epistaxis
(Nose Bleeds)
Eruptive Xanthomas
Eruptive xanthomas are yellow-orange-to-red-brown papules that are often surrounded by an erythematous halo. They appear in crops on the buttocks, extensor surfaces of the extremities, and flexural creases. Acutely, variable amounts of pruritus and pain occur. A Koebner reaction may be present. Lesions usually resolve spontaneously over weeks and may result in hypertrophic scars. Histologically, foamy macrophages are present in the dermis with an inflammatory infiltrate of lymphocytes and neutrophils.
Eruptive xanthomas can occur in the setting of chylomicronemia and hypertriglyceridemia. (Hypertriglyceridemia is a frequent side effect of Accutane.) This may be due to a primary hyperlipoproteinemia resulting from a genetic deficiency of lipoprotein lipase (Type 1 hyperlipoproteinemia) or familial hyperlipoproteinemia (Type V). Eruptive xanthomas often also occur secondarily in individuals unresponsive to insulin. Insulin is required for the normal triglyceride clearing function of lipoprotein lipase. Whenever insulin deficiency is present, an acquired lipoprotein lipase deficiency exists, which results in impaired clearance of chylomicrons and very-low-density lipoproteins causing the resultant hypertriglyceridemia. Rarely, eruptive xanthomas have been reported with hypothyroidism, nephrotic syndrome, and von Gierke's glycogen storage disease. They have been noted also after ingestion of alcohol, glucocorticoids, estrogens, and retinoids.
Other features of hyperlipidemia often noted in patients with eruptive xanthomas include lipemia retinalis, hepatosplenomegaly, and abdominal pain. The abdominal pain may be secondary to intestinal ischemia from increased blood viscosity, stretching of organ
Hirsutism
(Increased Hair Growth Even in Women)
Vasculitis Including Wegener's Granulomatosis
Wegener's Granulomatosis (WG) is a rare form of vasculitis; that is, a disease characterized by inflammation of the walls of the blood vessels. This inflammation can result in damage to vital organs of the body by restricting blood flow to those organs. WG normally begins as a localized granulomatous inflammation of the nasal mucosa (lining) and lung tissue, and usually progresses into generalized necrotizing (gradual degeneration) granulomatous (tumor-like) inflammation of the blood vessels. WG is an autoimmune disease, meaning the body's immune system attacks its own body tissue.
Although vasculitic diseases can result in damage to any organ system, WG primarily affects the respiratory tract (sinus, nose, trachea, and lungs) and the kidneys, and may involve the joints, eyes, ears, and skin. Patients who do not have renal (kidney) involvement are described as having Limited Wegener's. This disorder occurs equally in males and females and can occur at any age, but usually in middle age. For more information, please visit, Wegener's Granulomatosis Association
Accutane, manufactured by Roche, is a prescription medication used to treat severe acne. Accutane -- or Roaccutane, European brand name for Accutane, is usually the last line of treatment for cystic acne because of its uncomfortable and serious side effects. For this reason, medical professionals generally don’t prescribe Accutane unless the patient’s acne is particularly severe. Newsweek reports that "a good candidate [for Accutane] suffers from painful cysts over large regions of the back, shoulders or face." 1
A form of vitamin A, the drug decreases the amount of oil released by the sebaceous (oil) glands, facilitates the renewal of the skin, and increases the rate at which the skin renews itself. The active ingredient in Accutane is isotretinoin, which generally needs to be used for up to five months before a patient’s acne clears up. In addition to the side effects, a major drawback of Accutane is its high price tag - around $50 per pill. Patients should check with their insurance company to make sure the medication will be covered if money is an issue. Many insurance companies do not cover Accutane treatment.
How does Accutane work?
Accutane is an oral medication usually taken twice day. Since Accutane slows down the production of oils in the oil glands, pores begin to become unclogged and may stop clogging all together. The absence of clogged pores creates an absence of acne, since clogged pores is what causes acne in the first place. It may be as long as two months before a patient sees improvement in his or her skin. How long does it take to work? Though the full benefits of the taking Accutane may not show up until after five months of use, some patients experience improvements sooner. The most likely scenario is that acne will get worse during the first month or two of use and then gradually begin to work to patient satisfaction.
What kind of results can patients expect from Accutane?
Accutane works well for most patients. However, research has shown that about one person in ten will experience a return of their serious acne condition and need a second or third treatment.
What are the side effects of Accutane?
That Accutane has side effects is not a disputed fact. Before taking the medication, a patient, along with the help of his or her doctor, must determine if the benefits of taking Accutane outweigh its potential side effects. Following is a list of potential side effects. This list is by no means all inclusive:
Dry skin
Chapped lips
Dry eyes
Joint and muscle pain
Depression with or without suicidal thoughts
Increased sensitivity to sunlight
Nausea
Headaches
Increased levels of cholesterol
Women who are prescribed Accutane are urged not to get pregnant while taking the drug. This is because it can cause miscarriage and birth defects. Women taking oral contraceptives are advised to use a second form of birth control while in treatment. Anyone taking Accutane must be monitored closely to ensure that damaging side effects do not develop.
Does Accutane interact dangerously with anything?
Some birth control pills may not be effective when taken in combination with Accutane. In addition, the following drugs can be quite dangerous when taken with Accutane:
Ddemeclocycline
Doxycycline
Minocycline
Tetracycline antibiotic
Troleandomycin
Vitamin A
In addition to the above list, Accutane must not be taken with alcohol since the combination of the two can cause liver damage.
Symptoms of an Accutane overdose are clear; They include headache, nausea, abdominal pain, flushing, lip inflammation, dizziness, and a general awkwardness or clumsiness. Anyone experiencing these symptoms must immediately seek medical attention.
What is the most important information I should know about accutane?
• Accutane is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, accutane can cause serious side effects. Before starting treatment with accutane, discuss with your doctor how bad the acne is, the possible benefits of accutane, and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with accutane therapy.
• Do not take accutane if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking accutane. Accutane is in the FDA pregnancy category X. This means that accutane is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that accutane may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking accutane. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with accutane, during treatment with accutane, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking accutane. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking accutane and notify your doctor.
• Some patients have experienced depression (including feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite) and suicidal thoughts and/ or behavior during, and soon after stopping, treatment with accutane. Notify your doctor immediately if you begin to experience signs of depression or if you begin to have thoughts about taking your own life during or shortly following treatment with accutane.
• Do not take vitamin supplements containing vitamin A during treatment with accutane. This could cause increased side effects.
• Do not donate blood while taking accutane and for at least 1 month following the end of treatment. Blood donated while taking accutane may be given to a pregnant woman and be harmful to her baby.
• Do not use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking accutane and for six months following treatment due to the possibility of scarring.
• Avoid exposure to sunlight or UV rays while taking accutane. Accutane may increase the sensitivity of the skin to sunlight and a severe sunburn could result.
• Use caution when driving a vehicle at night. Accutane can cause decreased night vision. The onset of decreased night vision may be sudden.
• Take all of the accutane that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with accutane.
What is accutane?
• Accutane is a form of vitamin A. It decreases the amount of sebum (oil) that is released by the sebaceous (oil) glands, and it increases that rate at which the skin renews itself.
• Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
• Accutane may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking accutane?
• Before taking accutane, tell your doctor if you have
• a personal or family history of mental problems including depression, suicidal behavior, or psychosis (loss of contact with reality, hearing voices, or seeing things that are not there)
• diabetes
• asthma
• heart disease
• osteoporosis (bone loss) or weak bones
• anorexia nervosa
• high cholesterol or triglyceride levels (types of fat) in the blood or
• liver disease.
• You may not be able to take accutane, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Do not take accutane if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking accutane. Accutane is in the FDA pregnancy category X. This means that accutane is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that accutane may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking accutane. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with accutane, during treatment with accutane, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking accutane. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking accutane and notify your doctor.
• It is not known whether accutane passes into breast milk. Do not take accutane without first talking to your doctor if you are breast-feeding a baby.
How should I take accutane?
• Take accutane exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Accutane is a medication taken to treat severe nodular acne that has not been helped by other treatments, including antibiotics. However, accutane can cause serious side effects. Before starting treatment with accutane, discuss with your doctor how bad the acne is, the possible benefits of accutane and the possible side effects. Your doctor will ask you to read and sign a form indicating that you understand the serious risks associated with accutane therapy.
• Take each dose of accutane with a full glass of water. This will help prevent the medication inside the capsule from irritating the lining of the esophagus. For the same reason, do not chew or suck on the capsule.
• Take accutane twice a day with food or milk to get the best results from this medication, unless otherwise directed by your doctor.
• Take all of the accutane that has been prescribed for you even if your symptoms start to improve. The acne may seem to get worse at the start of therapy, but should then begin to improve. For the best results, finish all of the medication that has been prescribed. You may require more than one course of therapy with accutane.
• Your doctor may perform blood tests during treatment with accutane to monitor side effects from this medication.
• Due to the serious side effects that may occur with the use of this medication, do not share it with anyone else.
• Store accutane at room temperature away from moisture and heat.
What happens if I miss a dose?
• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
• Seek emergency medical attention.
• Symptoms of an accutane overdose include vomiting, abdominal pain, flushing of the face, inflammation of the lips, headache, dizziness, and clumsiness.
What should I avoid while taking accutane?
• Do not take vitamin supplements containing vitamin A during treatment with accutane. This could cause increased side effects.
• Do not donate blood while taking accutane and for at least 1 month following the end of treatment. Blood donated while taking accutane may be given to a pregnant woman and be harmful to her baby.
• Do not use wax hair removal systems or have any skin resurfacing procedures (such as dermabrasion or laser treatment) performed while taking accutane and for six months following treatment due to the possibility of scarring.
• Avoid exposure to sunlight or UV rays while taking accutane. Accutane may increase the sensitivity of the skin to sunlight and a severe sunburn could result.
• Use caution when driving a vehicle at night. Accutane can cause decreased night vision. The onset of decreased night vision may be sudden.
What are the possible side effects of accutane?
• Stop taking accutane and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
• an allergic reaction (difficulty breathing closing of the throat swelling of the lips, tongue, or face or hives)
• changes in vision, blurred vision, or decreased vision (especially at night)
• painful or constant dryness of the eyes
• depression including feelings of sadness, crying spells, irritability, changes in sleep patterns, unusual tiredness, trouble concentrating, loss of appetite, and/ or suicidal thoughts or other mental problems
• stomach, chest, or bowel pain
• rectal bleeding, or severe or bloody diarrhea
• difficulty or pain when swallowing
• new or worsening heartburn
• yellowing of the skin or eyes or persistently dark urine
• severe headache or dizziness
• seizures
• nausea and vomiting
• joint or muscle pain or bone problems
• hearing problems or hearing loss
• trouble breathing
• fainting
• increased thirst or urination
• slurred speech or problems moving
• leg swelling
• increased levels of cholesterol or triglyceride (types of fat) in your blood (detected by blood tests).
• Other, less serious side effects are more likely to occur. Continue to take accutane and talk to your doctor if you experience
• inflammation, dryness, or cracking of the lips
• dry skin, dry mouth, dry or bleeding nose, dryness of the eyes and/ or difficulty wearing contact lenses
• itching or
• increased sensitivity of the skin to the sun.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect accutane?
• Do not take any of the following medicines while taking accutane:
• vitamin supplements containing vitamin A or
• a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin, Panmycin, Robitet, others), minocycline (Minocin, Dynacin, Vectrin), doxycycline (Doryx, Monodox, Vibramycin, Vibra-Tabs), demeclocycline (Declomycin), or troleandomycin (TAO).
• Taking any of the drugs listed above during treatment with accutane may be dangerous.
• Before taking accutane, tell your doctor if you are taking carbamazepine (Tegretol, Carbatrol, Epitol). You may require a dosage adjustment or special monitoring during treatment.
• Do not use other acne medications unless otherwise directed by your doctor. They may interfere with the treatment or increase irritation of the skin.
• Do not take birth control pills that do not contain estrogen ("minipills") during treatment with accutane. They may not work while taking accutane.
• Drugs other than those listed here may also interact with accutane. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
Where can I get more information?
• Your pharmacist has additional information about accutane written for health professionals that you may read.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
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