Dermatology body urges FDA crackdown on Internet sales of Accutane (isotretinoin)
SCHAUMBURG, ILL., February 2, 2004 -- In a letter to the FDA,
the American Academy of Dermatology Association (AADA) called on
the agency to halt Internet sales of isotretinoin, commonly known
To assist government efforts, the AADA is providing the FDA with a
preliminary list of Internet sites from which isotretinoin can be
"The sale of isotretinoin over the Internet is not only a serious public health concern, it undermines the ability of the FDA to assess the success of the regulatory program in place for this drug," warned AADA President Raymond L. Cornelison Jr., MD.
Isotretinoin is a key treatment for severe cystic acne, yet the medication may result in serious side effects if taken incorrectly and should only be used by patients in consultation with their physician. Guidelines developed by the FDA and isotretinoin manufacturers prohibit Internet dispensing of the drug. Patients are required to bring a prescription form complete with a qualification sticker on it to pharmacists to obtain a one-month supply of the medication.
The Internet dispensing ban is associated with a voluntary pregnancy- prevention risk management program that all isotretinoin manufacturers, prescribers and patients are expected to comply with. Despite this ban, Americans are still able to buy the drug online and have it delivered directly to their homes.
Isotretinoin received FDA approval in 1982 for the treatment of severe recalcitrant nodular acne. For patients who are unresponsive to other standard acne therapies, it is an important medication. However, isotretinoin may cause birth defects in women who become pregnant while taking the drug. This led to the establishment of the current program to prevent female patients from starting isotretinoin treatment while pregnant or from becoming pregnant while taking the drug.
"While patients may be able to save time or money by purchasing isotretinoin directly from Internet vendors, the benefits certainly don't outweigh the risks of taking this powerful medication without proper medical supervision," commented Dr. Cornelison. "As the primary prescribers of isotretinoin, dermatologists are committed to the safe and responsible use of this drug and will fight to put an end to this type of unlawful dispensing."
Approximately 85 percent of all isotretinoin prescriptions in the U.S. are written by dermatologists. To view the AADA's policy on isotretinoin, visit its Web site at www.aadassociation.org/Policy/psisotretinoin.html
Source: American Academy of Dermatology www.aad.org
Posted: February 2004