Accutane (Isotretinoin) is typically prescribed to patients when other acne medications or antibiotics have proven ineffective in addressing severe acne. Physicians may also recommend this potent medication for purposes not explicitly listed. In most cases, Accutane is prescribed after other treatments have been unsuccessful in managing symptoms associated with severe acne.

Patients who are taking generic versions of isotretinoin should avoid the following:

• Vitamin A Supplements: Patients should be cautioned against taking dietary supplements containing vitamin A due to the relationship of vitamin A to Accutane and to avoid potential harmful effects.
• Tetracyclines: Cases of benign intracranial hypertension (pseudotumor cerebri) have been found to be associated with the concomitant treatment of tetracyclines and Accutane. As such, concomitant use of tetracyclines should be avoided.
• Systemic Corticosteroids: Osteoporosis has been found to develop from the use of systemic corticosteroids. Patients should be cautioned on concomitant use of Accutane and systemic corticosteroids.
• Phenytoin: A study involving seven healthy volunteers demonstrated that Accutane does not affect the pharmacokinetics of phenytoin. These findings align with the in vitro observation. It is determined that isotretinoin and metabolites do not inhibit or induce CYP 2C9 human hepatic P450 enzyme and its activity.
• Progesterone: The use of low-dose progesterone preparations during Accutane treatment may not provide a sufficient and reliable contraceptive method. Cases have documented that pregnancy has occurred in female patients taking implantable or injectable contraceptive products and oral contraceptives. As such, patients are advised to use two effective forms of birth control before starting isotretinoin therapy.

Before the initial prescription of generic versions of isotretinoin, female patients of childbearing age must undergo two serum or urine pregnancy tests and have negative test results. The first pregnancy test serves as a screening test. It is performed to determine if the patient is eligible for the medication. The second pregnancy test is a confirmation test. It must be performed immediately once Accutane therapy has started and within the first five days of the menstrual cycle. Furthermore, there must be two pregnancy tests 30 days apart, both with negative results.

Patients who are pregnant or planning to become pregnant are advised not to take isotretinoin. The potential medication may cause severe birth defects if the female patient takes the medication during pregnancy. Major birth defects may occur, even from taking one dose, including the baby’s brain, heart, skull, face, eyes, and ears. According to contraindications and warnings for nursing mothers, it is not yet known if the medication is excreted in breast milk. As such, nursing mothers are advised not to take the drug due to potential adverse effects.

If a female patient has not experienced continuous menopause for a minimum of 12 consecutive months or undergone a total hysterectomy (removal of ovaries and uterus), it is advised not to use isotretinoin without the use of birth control. Even if a woman has undergone a total hysterectomy, it is recommended to use birth control if planning to take the medication. Patients taking isotretinoin should stop taking the drug and see their physician immediately if they believe they may be pregnant, experienced a late period, stopped using birth control, or have had unprotected sex.

Before starting isotretinoin, patients must enroll in the iPledge program. This safety program oversees and tracks the effects of the medication. This serves to minimize fetal exposure and the potential for defects in a developing fetus (teratogenicity). It also gathers information on pregnancy and other relevant details concerning medication usage. The other goal of the safety program is to inform and warn patients, pharmacists, and prescribers on how to safe usage and serious risks. It is required by the FDA to ensure that the benefits of the medication outweigh the potential risks.

Consulting with a physician before starting generic versions of isotretinoin is crucial for several reasons, including a patient assessment, explaining medication side effects, individualized treatment plans, monitoring health, and addressing concerns. A patient with the following conditions should speak with a physician to determine if they are able to take Accutane:

• Asthma
• Diabetes
• Liver disease
• Eating disorders
• Triglycerides, high cholesterol, or heart disease
• Osteoporosis or other disorders affecting the bones

Patients considering generic versions of isotretinoin or currently taking the medication should follow orders from their physician and attend regular check-ups.

In June 2009, Hoffman-LaRoche sent a letter to the FDA providing notification of the removal of Accutane. The capsules, 40 mg, 20 mg, and 10 mg were discontinued. It was later added to the FDA’s Discontinued Drug Product List. A statement from the company indicated that the cost of legal proceedings and market pressures led to its removal, not safety concerns. While the product has been removed from the market, there are generic versions of the medication available today. A wide array of adverse side effects has been reported, including fetal deformities, suicidal thoughts, and depression.

If an individual has experienced harm from the use of a dangerous drug, the first step in holding a manufacturer accountable for injuries and losses is to consult with an experienced attorney. A lawyer with extensive experience in product liability law can assess the specifics of the situation, including the extent of injuries and losses, monitor the FDA’s FAERS database for adverse events associated with the medication, and determine if they are eligible to bring a case forward. The right attorney will know how to build the strongest case possible to obtain justice and maximum compensation.

Manufacturers have a duty to sell reasonably safe products on the market. If a manufacturer fails to uphold this obligation, they may be held strictly liable for damages under California law. If you have experienced adverse harm from the use of a medication, our California-based drug product liability lawyers are available to evaluate your potential case. We proudly offer free, friendly case advice when you dial (916) 921-6400 or (800) 404-5400. Our legal team can assess the specifics of your situation, determine whether you have grounds for a claim, and advise you on what to expect moving forward.

^{Picture Source: By KarolinaGrabowska through Pexels.com ds [cs 1058]}