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Last 8th of August, Dermatology researchers at the University of California, San Francisco have released the analysis of various abnormalities caused by taking the acne drug Isotretinoin.

The study comprising exactly 13,772 acne sufferers aged 13 to 50 showed raised levels of triglyceride lipid esters in about 44 percent of patients with previously normal levels. Overall levels of cholesterol were reported higher for around 31 percent of patients. Abnormal results for liver function and cholesterol levels were more common than previously expected, which stressed the need for a more rigorous control of people taking the drug.

The study also confirmed 11 percent increase in liver enzymes, abnormal liver tests, resulted from taking the drug. However, the aforementioned levels resumed to normal/pretreatment levels in most of the patients months after discontinuing isotretnoin intake.

Currently cited in the drug’s package label, Isotretinoin, marketed in the U.S. by Roche as Accutane, showed higher triglyceride levels in 25 percent of patients. 7 percent showed increased cholesterol levels.

Most acne patients and doctors already knew beforehand of the drug’s complications, which include high liver enzymes, the rare liver damage, and intestinal and esophageal complications.

Patients cost them 10 to USD15 a pill, which they take less than a year if found effective. Most of the time, the drug takes effect only after three courses of isotretinoin. It is considered one of the most effective treatments for severe cystic acne vulgaris. It was also tested as a bioadjuvant therapy for patients with head and neck cancer but significantly failed after phase three of the clinical trial.

Registry Issues

The Food and Drug Administration began requiring dermatologists and their patients to register their use of the drug, a program aimed at stopping pregnancy of isotretinoin patients, eventually preventing birth defects, last 1st of March.

The acne medication, whose manufacturers already incur scrutiny, may also cause brain damage, cleft lip, heart defects in infants if a woman takes it while pregnant or right before pregnancy. For this reason, women are now required to enroll in a rigorous screening program dubbed iPledge.

More than 160,000 patients have registered with iPledge. Female patients require:

1. taking two forms of birth control,
2. pregnancy tests prior to, during and after taking isotretinoin, and
3. furnish the form found on the iPledge Web site.

Prescriptions only last for 30 days and must be filled within seven days of check-up.

Acne sufferers from various acne discussion fora have expressed dismay in the iPledge program, however well-intentioned. They have reported long hours of waiting to get through the iPledge hotline. Several patients have even been unable to access their compulsory iPledge membership accounts, the acne forum members said.

For this reason, an alternative solution to the poorly executed iPledge is being proposed, called the Smart Card. Further testing and experimentation are yet to be performed to determine its efficiency.

The iPledge program is administered by Covance Drug Development Services in partnership with various isotretinoin manufacturers.

Sources
Zane, L. T., et al. Archives of Dermatology, August 2006. A Population-Based Analysis of Laboratory Abnormalities During Isotretinoin Therapy for Acne Vulgaris.
Archives of Dermatology. 2006;142:1055-1057. The Smart Card: An Alternative Solution for the iPledge Program.
The iPledge website on-line https://www.ipledgeprogram.com/
References
Khuri FR, J Natl Cancer Inst. 2006 Apr 5;98(7):426-7. Randomized Phase III Trial of Low-dose Isotretinoin for Prevention of Second Primary Tumors in Stage I and II Head and Neck Cancer Patients.

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