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Pull Acne Drug Accutane From Market, Critics Ask FDA

Prescriptions should be restricted because of link to birth defects, Public Citizen claims

THURSDAY, Feb. 26, 2004 (HealthDayNews) -- Prescriptions for the controversial acne drug Accutane should be severely restricted because an outreach program designed to prevent its use during pregnancy has failed.

That was the assessment of Dr. Sidney Wolfe, director of the non-profit advocacy group Public Citizen, who testified Thursday before a U.S. Food and Drug Administration advisory committee in Washington, D.C.

The hearing marks another chapter in the checkered history of Accutane, which experts agree can cause birth defects. Debate also continues over possible links between Accutane and suicidal depression, especially among teenagers using the drug.

The FDA committee heard testimony on the level of effectiveness of a program aimed at lowering the use of Accutane, as well as its three generic versions, among pregnant women. Among its other initiatives, the SMART program, which has been running for a year, specifically requests that women provide negative pregnancy tests each month before they can fill a prescription for that month's dose of Accutane. The program was launched by the FDA and Accutane's maker, Roche Pharmaceuticals Inc.

"The SMART program has been in effect for a year, we have a year's worth of data, so what's the story? The story is that it doesn't work at all," Wolfe said in an interview with HealthDay.

Using FDA data, Wolfe estimates that 158,000 American women took Accutane during the year SMART was in effect, with 548 pregnancies occurring among female users during that time. The FDA received data on 61 of those pregnancies, and found that 48 of them (nearly 79 percent) ended prematurely when the women elected to abort, usually due to fears of Accutane-linked birth defects, Wolfe says.

When those numbers are expanded to the estimated 548 total pregnancies among Accutane users, Wolfe says, the number of elective abortions among users of Accutane rises to 431.

According to FDA statistics, nearly 2,000 women are known to have taken Accutane while pregnant between its approval in 1982 and the year 2000. Of the 383 live births recorded among this group during that time, 162 resulted in infants with birth defects.

Public Citizen has lobbied for years for restricted access to prescriptions for Accutane, which is specifically aimed at treating the most severe form of acne, such as cystic acne. In many cases, Accutane is the only effective treatment for this disorder, which can cause scarring of the affected area.

But Wolfe points out that, based on federal data, only 6,000 U.S. women of childbearing age now suffer from severe cystic acne, while more than 156,800 women in this age group were prescribed the drug in 2002-2003. Programs such as SMART aren't doing enough to keep the drug away from women who may not even need it, and who might become pregnant, he says.

His answer? Accutane and its generic equivalents should be "taken off the market as a danger," and prescribed to young women with three stipulations:

  • photographic proof of severe cystic acne, that is then agreed upon by an independent panel of dermatologists,
  • written records that prove alternate medications have not been effective,
  • a written statement outlining the female patient's method of contraception, as well as copies of monthly negative pregnancy tests, presented each time the drug is dispensed.

But not everyone agrees that such drastic steps need to be taken.

Carolyn Glynn, vice president of public affairs for Roche, attended the Washington hearings and believes it's far too early to pass judgment on the SMART program.

"If you ever looked at the pregnancy rates for this population you'd see that this has been an extraordinarily effective program, given the number of pregnancies," she says. "I think it's just too premature to assess this program."

Glynn also believes decisions to treat patients are best left in the hands of their doctors. "A lot of the presentations that were given today by dermatologists and by members of the FDA indicated that it's very difficult to classify acne," she says. "For example, if you see a patient who is moving toward the scarring form of acne, but doesn't yet have it full-blown so that it causes scars, is that not an appropriate candidate?"

"Dr. Wolfe is certainly entitled to his opinion," Glynn adds. "But I think it needs to be a combination of regulatory authority, the [actions of] companies that manufacture the drugs and physicians, as well as the patient -- everyone has a role here."

Left out of Thursday's discussion was the controversy surrounding alleged links between Accutane and suicidal depression, especially among teenagers. Roche says scientific data supports its claim that no such link exists. Public concerns led the company in 2002 to revise the drug's labeling, advising prescribers to look out for signs of depression and suicidal tendencies in users.

Wolfe says that although his prime concern for Thursday's testimony was Accutane's proven links to birth defects, its possible links to depression remain "worrisome."

For her part, Glynn says officials at Roche "stand firm that there is no [such] link to Accutane."

The FDA committee could issue its recommendation as early as Friday.

More information

For more on Accutane, visit the Center for Drug Evaluation and Research and the University of Iowa.

SOURCES: Sidney Wolfe, M.D., director, Public Citizen, Washington, D.C.; Carolyn Glynn, vice president, public affairs, Roche Pharmaceuticals Inc., Nutley, N.J.; Feb. 26, 2004, U.S. Food and Drug Administration advisory committee hearing, Washington, D.C.
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