women who take the drug, male patients must also participate in anti-pregnancy restrictions, primarily due to fears that male isotretinoin users might share their prescriptions with females without their physicians' knowledge. There has been no link to birth defects from Accutane associated with males using the drug, though male sexual dysfunction has been suggested by one study. As this has not been conclusively proven, this is not acknowledged as a side effect in the official literature accompanying the medication. As of December 13, 2021, IPLEDGE launched a nationwide update to their system against the AAD's recommendations, the AAD claimed this change would slow down a patient's ability to receive their prescription. The phone system on launch day was completely suspended providing no available support to users trying to navigate a new system that is full of bugs. There has since been long hours of waiting on the phone to get support and when connected with someone are told they received word "not to give out any information. If there are questions you should call the number on the letter sent out or email the original sender that distributed the information." Neither of these had worked at the time. IPLEDGE and the FDA have been heavily under fire in the dermatologic community due to these changes. The AAD issued a statement claiming the IPLEDGE issues are unacceptable and states, "Over the last several weeks we have repeatedly warned the FDA and Syneos that the proposed changes did not reflect clinical practice and would impede patient care; and we asked for a halt to the program until our concerns could be addressed. We were told “no,” with the explanation that suspending the iPLEDGE program would not, from FDA’s perspective, provide the safeguards that are necessary to prevent embryofetal exposure." References External links ipledgeprogram.com The official iPledge program web site. REMS document FDA press release about the program Information from the CDC CDC and the March of Dimes Isotretinoin and other retinoids during pregnancy Medscape Medical News, Dermatologists Frustrated With Problematic iPledge Program, AAD 64th Annual Meeting. Focus session, March 6, 2006 AAD's 12/13/2021 statement Pharmaceuticals policy Pharmacy in the United States Isotretinoin