EDITORIAL:Risky drug goes over the counter
November 13, 2002
The medication Accutane has been called names ranging from a “miracle drug” to “dangerous.” It can clear up a person’s skin, but there has been evidence of the drug causing birth defects and mental problems in its worst cases. Since the drug’s introduction in 1982, physicians and the Food and Drug Administration have worked to educate its users of its potential risks.
Soon acne sufferers will be able obtain a generic form of the drug, under its chemical name — isotretinoin.
The approval of this generic drug presents a real danger that has sparked concern among health officials that users will not associate the generic drug’s name with the potentially severe side effects.
Accutane is not prescribed to the average person with an occasional pimple. It is used to fight nodular acne after several other drugs have been used to no avail. In today’s society, where there is such an emphasis on physical beauty, providing a generic drug that is equally as potent as Accutane could cause some confusion.
There have been two high-profile cases in which teenagers have ended their lives while on Accutane. On May 14, 2000, Michigan state Sen. Bart Stupak’s 17-year-old son shot himself after being put on the medication for six months. According to a Washington Post article, the FDA issued a MedWatch report on the drug in February 1998 that advised of “isolated reports of depression, psychosis and rarely suicidal thoughts and actions.” It also stated that the FDA and Accutane’s manufacturer, Roche Pharmaceuticals, would include the information on the warning label.
The Stupaks looked at their son’s prescription, and the warning label only warned of “changes in mood.”
In January, a 15-year-old flew a plane into an office building in Tampa, Fla. He was on Accutane at the time, and the boy’s mother has filed a $70 million wrongful death lawsuit against its manufacturer.
It has become more difficult to obtain the drug. Last spring the FDA and Roche required a doctor’s certification that each female patient had a negative pregnancy test. It also stressed a ban on pharmacies filling Accutane prescriptions without the required certification and release of only one month’s supply at a time. The FDA and Roche also began requiring female patients to get a new pregnancy test before each renewal, according to The Associated Press.
Users should not only rely on doctors when seeking advice about taking Accutane or isotretinoin — they should educate themselves. There are plenty of resources, such as the FDA’s Web site at www.fda.gov.
Accutane is a dangerous drug, although it can improve self-confidence and appearance. Be aware that the generic drug is on the market its potential to harm. Although the name isotretinoin has not been associated with the attention that surrounded Accutane, that doesn’t mean that it’s not as life-altering.
Editorial Board:Cavan Reagan, Amber Billings, Ayrel Clark, Charlie Weaver, Rachel Faber Machacha, Zach Calef.