Accutane / Roaccutane - Isotretinoin

Illegal Accutane

Accutane (isotretinoin) information

History

Gerald Peck and co-workers from the NIH (National Institutes of Health) in Bethesda, Maryland, first studied isotretinoin in patients with skin cell disorders. They accidentally found that it also worked on patients with severe acne. Isotretinoin was registered in 1979, released in the United States in 1982 as Accutane, and released in Europe in 1985 as Roaccutane.1

Roche's patent expired in 2002, and manufacturers began selling generic forms of the drug.

In late June, 2009, shortly after a jury awarded $33 million in damages to people who claimed Accutane caused bowel disease, Roche decided to discontinue selling brand name Accutane. The company cited declining sales as their reason.

Pregnancy prevention programs

Roche started with a program called SMART (System to Manage Accutane Related Teratogenicity) in 2000, which became the iPLEDGE program in March, 2006. Female patients of childbearing age are required to use two (2) forms of birth control while on Accutane.

iPLEDGE program telephone: 1-866-495-0654
iPLEDGE program website: ipledgeprogram.com2

Accutane is the #1 prescribed teratogenic (causes birth defects) medication in the United States.3

Warning: Do not buy Accutane on the Internet4

According to the FDA:

  • "...Buying (Accutane) over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects..."
  • You should NEVER buy Accutane (isotretinoin) without first seeing your healthcare professional.
  • You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or could accidentally become pregnant.
  • Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.

I will personally add to this:

Buying Accutane or any other prescription over the Internet often means you will receive pills that contain little or no active ingredient, or in some cases, a different medication entirely. Buying Accutane over the Internet is not only illegal, it is potentially dangerous and is also a waste of money.4 I agree strongly with the FDA. NEVER buy Accutane over the Internet.

Topical Isotretinoin

Topical isotretinoin exists but does not produce the results of oral isotretinoin. It is largely of historical significance in acne treatment.

Manufacturer

F. Hoffman-LaRoche, Ltd. (also known as Roche)
340 Kingsland St.
Nutley, NJ 07110

Roche announced on July 22, 2008 that it is moving its headquarters to South San Francisco. This move should be complete by 2010.5

Some of the common misspellings of Accutane include: acutane and accutaine.

References

1. Kligman, Albert M., Gerd Plewig. Acne and Rosacea. Berlin: Springer, 2000.

2. Cruzan, Susan. "FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne." U.S. Food and Drug Administration. 12 Aug. 2005.

3. Honein MA, Paulozzi LJ, Erickson JD. "Continued occurrence of Accutane-exposed pregnancies." Teratology. 2001 Sep;64(3):142-7.

4. "FDA Consumer Safety Alert: Don't Buy These Drugs Over the Internet or From Foreign Sources." Food and Drug Administration. 2010. link

5. Cohen, Robert. "Roche is moving Jersey headquarters to California." The Star-Ledger. 22 Jul. 2008.