The side effects threats of acne treatment Accutane and its active ingredient, Isotretinoin, led the Food and Drug Administration in 2005 to approve a mandatory risk management program for the drugs called iPLEDGE.
The iPLEDGE program is designed to reduce if not eliminate exposure to the drug Isotretinoin by pregnant women. Such exposure can lead to depression and suicidal impulses as well as to birth defects in newborns. It also can cause an inflammatory bowel disease, or IBD, such as Crohn’s Disease or Ulcerative Colitis, though the iPLEDGE program is not designed to combat those.
Many pregnant women have been exposed to the teratogenic drug Isotretinoin via Accutane and generic Accutane products by using them as acne treatment. The FDA strongly urges against this. The iPLEDGE program entails mandatory registration of prescribers, patients, wholesalers and pharmacies when it comes to Isotretinoin tablets or Accutane.
By this means, it is hoped that women who are pregnant or may soon become pregnant will be identified by physicians and will be steered away from Accutane and Isotretinoin use.
Yet defective drugs Accutane and Isotretinoin can be harmful for anyone, especially in terms of an IBD or bowel disease which can be lifelong and debilitating. Such bowel diseases as Crohn’s Disease and Ulcerative Colitis can be very costly and damaging to victims of Accutane and Isotretinoin, which is why an Accutane lawsuit or defective drug lawsuit may be vital.
Persons who have suffered Crohn’s Disease, UC or another IBD or bowel disease as a result of taking Accutane, generic Accutane or Isotretinoin tablets are advised to notify an Accutane lawyer with Accutane Lawsuit Lawyer.com. It can help Accutane victims seek fair and just financial compensation for their losses, including medical bills, lost wages and pain and suffering.
To begin the process of seeking such recovery, fill out the free case evaluation form on this website or call toll-free to 1-800-339-0606 and a legal representative will get back to you quickly to help you assess your case. The negligent manufacturers whose mistakes caused you harm can be held accountable in the legal arena via an Accutane lawsuit from an Accutane defective drugs lawyer or attorney.