Amnesteem Side Effects

Serious side effects

• vision problems including cornea film development, decreased night vision and problems with contact lenses, inflammation, cataracts, dry eyes and sensitivity to light
• cardiac problems such as palpitations, rapid heart rate, stroke, inflammation of blood vessels, and blood clots, with chest pain
• pancreatitis and inflammation of the kidney, with liver problems including dark urine, clay-color and tarry stools, rectal bleeding, dry mouth and yellowing of the skin/eyes
• changes in blood levels including elevated/decreased blood sugar levels, high triglyceride levels and anemia, with increased chances for infection and bruising from low platelet, neutrophil and granulocyte counts
• bone, muscle and joint pain/stiffness from decreased bone mineral density, arthritis and tendonitis
• digestion problem indicators such as spreading pain in the abdomen, inflammatory bowel disease, inflammation of gums, colon and esophagus, with severe diarrhea, and severe nausea or vomiting
• hearing impairment that may become persistent with ringing in the ears
• seizures and sudden numbness/weakness on one side of the body, with severe headaches
• mental and/or mood changes that may include thoughts of suicide, depression, aggression, instability, trouble concentrating/restlessness, hallucinations and sleep problems
• signs of an infection including fever, chills, body aches, flu-like symptoms, and sore throat/painful swallowing
• skin complications like tingling of the skin, purple spots under the skin, peeling on the palms and soles, and Stevens-Johnson syndrome
• allergic reactions such as rashes, swelling of the face, sudden dizziness and trouble breathing

 

Common side effects

• changes in weight and appetite that stem from depression, with fatigue, insomnia, nervousness and drowsiness also occurring
• nose bleeds and respiratory complications like spasms and infection
• minor nausea/vomiting and minor joint and abdominal/back pain
• women may experiences spotting between periods
• overall dryness of skin including dry mouth, nails, hair, nose and lips, with skin cracking and peeling
• hair changes may occur like the thinning or abnormal growth, with minor swelling of the eyelids and lips
• skin abnormalities like the return of acne, alopecia, yellow or red patches with blisters, changes in skin pigmentation, nail fungus, sun sensitivity, hives and rashes with severe itching and increased sweating, and overgrown tissues beneath the skin

 

Warnings & Recalls for Amnesteem

Patients who have had a history of depression or mental illness, heart disease, osteoporosis, inflammatory bowel disease, diabetes, asthma, liver disease and high triglycerides should consult with their doctor before taking Amnesteem.

Since Amnesteem causes sensitivity to light, patients should avoid sunlight exposure and wear protective items, and may also experience some discomfort while wearing contact lenses during and for some time after taking Amnesteem.

Amnesteem may inhibit the ability to see in the dark and therefore patients should proceed with caution while performing activities at night or in the dark.

Those who are allergic to isotretinoin or any of its ingredients (yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, soybean oil, glycerin, red iron oxide paste and black ink, yellow iron oxide paste, and titanium dioxide) should not take Amnesteem.

Amnesteem can only be prescribed by physicians who are actively registered with the iPLEDGE program, and can only be taken with patients who have signed the agreement with iPLEDGE.

Patients should avoid waxing and laser treatments or dermabrasion for at least 6 months after taking Amnesteem because of the risk of scarring.

Those who partake in strenuous physical activity should proceed with caution because of Amnesteem's ability to weaken bones. Fractures and delayed healing of bones have been reported.

Since Amnesteem can be fatal to the fetus, patients should not donate blood during treatment, or for at least one month after treatment, in risk that the blood might be exposed to a pregnant woman.


Contraindications:
Contraindications include medications for seizures, oral steroids, antibiotics, vitamin A supplements, tetracyclines,  micro-dosed progesterone preparations, norethindrone/ethinyl estradiol, St. John's Wort, phenytoin, systemic corticosteroids, anticonvulsants and vitamin D supplements.


Family Planning:
Pregnant women SHOULD NOT TAKE THIS MEDICATION!

Amnesteem is categorized by the FDA in pregnancy category X, meaning that the drug will cause severe fetal harm if taken while the patient is pregnant. This drug has a high risk for such birth defects as feature abnormalities, central nervous system defects, cardiovascular system complications, spontaneous abortion and miscarriages, thymus gland and parathyroid hormone abnormalities.

In order to take Amnesteem, the patient must have a negative reading on a pregnancy test 30 days before beginning the drug, in between each prescription, after the last dosage of the drug, and 30 days after the discontinuation of Amnesteem.

If the patient discovers she is pregnant, the fetus may be harmed, even if she has only taken Amnesteem for a short time. The pregnant female should discontinue Amnesteem immediately and seek medical attention for testing and monitoring. Patients should be warned that there is not an accurate way to determine if the fetus has been affected by the drug.

Females should start using a primary and secondary forms of contraception together for 1 month before taking Amnesteem and for 1 month after discontinuation, with continuous pregnancy tests, and must attest to this in writing form with the iPLEDGE. Primary forms of birth control include tying tubes, vasectomy, intrauterine device (IUD), estrogen birth control pills and hormonal patches, implants, injections or vaginal rings, while secondary forms of birth control include latex condoms with spermicide, diaphragms with spermicide, cervical caps with spermicide and vaginal sponges with spermicide.

Amnesteem has also been found in semen, but the amount transferred to a female sexual partnerwould not pose the same risks as if a female were taking the drug while becoming pregnant. Some risks are evident, but none to conclusively state that male sperm poses a threat when meeting with an egg.

Nursing mothers are advised DO NOT BREASTFEED while taking Amensteem, and for 1 month after the discontinuation of the drug, as the drug can be passed through the breast milk.

Amnesteem Treatment and Use

What is Amnesteem?

Amnesteem is a retinoid used to treat severe acne (nodular or cystic acne) that hasn’t responded to any other medication.

 

How does Amnesteem work?

Sebum is facial oil that is released by oil glands that can cause severe acne. Amnesteem reduces the amount of sebum produced or released, and therefore decreases the amount of acne in the surrounding areas.

 

Dosage Information

Amnesteem comes in 10 mg, 20 mg and 40 mg capsules that should be swallowed whole and taken with meals. The dosage of Amnesteem is adjusted by a physician according to a patient’s condition and responses, but is usually taken for 15-20 weeks, twice a day.

After taking this drug, patient’s are advised to not lie down until more than 10 minutes. Acne may continue or worsen for the first couple of days, and it may take 1 to 2 months before the full effects take place. Before another form of acne medication can be started, patient’s must stop taking Amnesteem for at least 2 months.

Other Names for Amnesteem

Amnesteem is also known as Isotretinoin, Claravis and Sotret.

Lawsuits & Legal Information for Amnesteem