Accutane related birth defects are common for mothers who have taken the drug while pregnant, and any doctor that prescribes the medication to an expecting woman is acting negligently. Several countries, including the U.S., Australia and Germany have all acknowledged the dangers associated with this drug for pregnant women. In fact, the FDA has given the medication a rare ‘X’ classification, which is reserved for substances that have demonstrated a significant chance of causing deformities.
Isotretinoin is the active ingredient in Accutane and causes birth defects in 25 to 35 percent of pregnant women who take it. It is used to treat cystic acne and is typically applied to the skin. It is also used as a form of chemotherapy for people with brain and pancreatic cancer. Isotretinoin’s mechanism of action is not well understood by doctors, as the substance can have major and permanent effects on the biogenetics in the body. One study recorded major changes to several hundred genes in the skin after just eight weeks of use. While it can permanently alter sebum production (the material that causes acne), it can also affect cells in the eye and brain.
In fact, Accutane related birth defects aren’t the only side effect this medication can cause. Anemia, immunological hypersensitivity, hair loss, back pain, depression, aggression, anxiety, convulsions, blurred vision, impaired hearing, inflammatory bowel disease, stunted growth and arthritis are also among complications patients have reported. These are just a few of the adverse effects that have been noted, and some of them can lead to permanent complications.
The reason why Accutane causes birth defects is that isotretinoin is chemically similar to retinoic acid. This derivative of vitamin A is crucial for proper embryonic development, as it signals embryonic positioning in the womb. In pregnant women, isotretinoin can interfere with this process and mistakenly be used by the body as retinoic acid. This can result in major and permanent debilitations in the fetus. The most common deformities are vision and hearing impairment, facial dysmorphism, missing earlobes and mental retardation. The FDA has tested many children affected by the medication, and has confirmed that it is responsible for reduced IQ in many of the tested children. Between 1982 and 2003, more than 2,000 women became pregnant while on the medication, and the majority of these pregnancies ended in abortion or miscarriage. Around 160 children were born with deformities.
The problem is so severe that the FDA set up the iPLEDGE program in 2005 to stem the tide of pregnant women taking the drug. This program is meant to stop Accutane birth defects by only allowing doctors registered with iPLEDGE to prescribe isotretinoin. Patients must also be registered with iPLEDGE before they can receive the drug. The idea is to control the distribution of the medication.
Anyone who has taken Accutane and suffered major complications involving the drug should consider consulting with a drug injury attorney to explore their options. This medication is extremely dangerous when it is not prescribed and dosed properly. Thousands of law suits have already been resolved with Hoffman-La Roche, and a victim may be able to attain compensation after consulting with a legal expert.