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Drugs, chemicals, radiation & herbal products in pregnancy: DERM: Side-effects of popular acne drug prompt debate over prescribing rights

By Celia Milne

TORONTO | Soon doctors may need more training to prescribe Accutane.

Health Canada will rule shortly on whether the acne drug isotretinoin is to be more strictly controlled because of its potential to cause malformations in babies of women who get pregnant while taking it.

Doctors are divided on whether this is necessary.

"It should be very, very controlled," said Dr. Gideon Koren, director of the Motherisk program at the Hospital for Sick Children in Toronto. He has suggested for years that Canada require registration by patients and prescribers, a system the United States adopted in 2002.

But some dermatologists, who are the largest prescribers of isotretinoin, don't agree.

"I believe most of my colleagues would agree with me that physician and patient registration is unnecessary," said Dr. Peter Vignjevic, a dermatologist in Hamilton.

About 40% of fetuses exposed to isotretinoin in the first trimester will have major malformations, according to Motherisk. But the drug's danger is often invisible; even babies who are spared from major malformation may still be affected by cognitive deficits.

Motherisk tries to keep track of how many women get pregnant while on isotretinoin. "We collect 10 to 20 cases every year; most are not known to Health Canada," said Dr. Koren. Not all cases are reported to Motherisk, so the numbers may be higher. "This is a totally unacceptable risk," he added.

He said physicians prescribing isotretinoin should be further trained. A brief educational program culminating in a test could be offered through an accredited institution or even online, Dr. Koren suggested. Successful doctors would then be certified and registered as prescribers of isotretinoin. Examples of other drugs requiring certification are thalidomide and methadone.

But Dr. Vignjevic argued that all drugs carry some risk, and doctors must always familiarize themselves with those risks and benefits.

"Accutane has the potential for severe side-effects (teratogenicity, hepatotoxicity etc.) but when used properly these risks can be minimized," he said. "Any drug can be dangerous if used improperly; even an over-the-counter drug like Aspirin or Tylenol can have life-threatening side-effects. As such, physicians using this drug should familiarize themselves with its correct use."

Dr. Vignjevic runs a medical and cosmetic dermatology practice in which more than 90% of of his patients present with acne, psoriasis or skin cancer. "Accutane is extremely helpful for patients with severe or resistant acne. I have treated many patients with it," he added.

Still, Dr. Koren said that in the case of isotretinoin, there are several factors brewing to create the perfect storm:

The exclusive patent for Accutane has run out, allowing generics to enter the lucrative market. Sales of Accutane in Canada in 2004 amounted to almost $37 million, according to IMS Health Canada figures. Three generic forms of the drug are now available in the United States, and several may be introduced in Canada soon. This will drive the price down, and possibly demand up.

Prescribing of Accutane is now often being done by general practitioners. While 34.3% of prescriptions were by GPs and FPs in 2000, this group accounted for 37.5% of prescribing in 2004, reported IMS.

New off-label uses for isotretinoin have emerged, including treatment of gram-negative folliculitis, recalcitrant rosacea, pyoderma faciale, generalized lichen planus, psoriasis, cutaneous lupus erythematosus and acne fulminans, and, more recently, squamous cell carcinomas and leukemias.

As a result, Health Canada has set up a Scientific Advisory Panel on Isrotretinoin, which includes experts from dermatology, psychiatry, pharmacy, bioethics and obstetrics. They met on May 12, and their recommendations were due at the end of June. The record of proceedings was to be posted when approved by panel chairman Dr. Jack Toole, head of the section of dermatology at the University of Manitoba's faculty of medicine in Winnipeg. This is a process that Christopher Williams, spokesman for Health Canada, said usually takes about six weeks.

Health Canada already requires that women taking isotretinoin give written informed consent, be made aware of the teratogenicity of the drug and agree to using two contraceptive methods while on the drug. Similar efforts in the U.S. were ruled by the FDA to be insufficient protection for fetuses. In 2002, that country adopted the SMART program (System to Manage Accutane Related Teratogenicity) whereby doctors and patients using the drug must be registered.

Dr. Koren insists the same must be done in Canada.

"The flooding of the market with new and cheaper forms of generic isotretinoin is likely to endanger the lives of many more unborn Canadian babies. We need to take steps to protect the unborn from irresponsible prescribing," Dr. Koren and colleagues wrote recently in the Canadian Medical Association Journal.

© Copyright 2003 The Medical Post. All rights reserved.

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