Wed, May 26, 2010 - Page 2 News List

More protection urged for off-label drug users

By Shelley Huang  /  Staff Reporter

Despite research showing that adverse reactions to the epilepsy drug Carbamazepine are highly frequent, patients who have such reactions will not qualify for the Department of Health’s (DOH) drug relief program because the drug is mainly prescribed by doctors for “off-­label” use, Democratic Progressive Party (DPP) Legislator Huang Sue-ying (黃淑英) said yesterday.

At a press conference yesterday, Huang cited the case of a man, surnamed Hsu (徐), who had experienced an adverse reaction to the drug but could not receive drug relief compensation, saying that this highlighted a serious problem caused by the failure of the health authorities to provide the public with protection against drugs that were prescribed off-label.

Doctors may legally prescribe drugs off-label if the drug is safe to use and found to be effective in treating a certain condition that it has not yet been approved for. For example, Carbamazepine, which has been officially approved for use in treating epilepsy, is also often prescribed by doctors as a mood stabilizer or pain reliever.

“While it is legal for doctors to prescribe drugs off-label, patients who follow their doctor’s instructions to take the drug cannot receive any help or compensation if they have an adverse reaction because the DOH’s drug relief program then deems off-label use illegal, which is unreasonable,” Huang said.

Huang cited statistics from the Drug Relief Foundation, which showed that from 2005 until last year, there were 299 cases of patients who had adverse reactions to drugs but could not receive compensation. Of the 299 cases, 101 (34 percent) were patients who used off-label drugs.

She also cited a research study by Academia Sinica in April 2004 that showed as many as 5 percent of people in Taiwan carry a gene that has shown to increase the risk of developing Stevens Johnson syndrome as a reaction to taking Carbamazepine. As a result, compared with the relatively low rate of white Caucasians who carry this gene, Taiwanese are 30 times more at risk of developing the syndrome in reaction to the drug.

Huang urged DOH officials to re-evaluate whether Carbamazepine should be legally approved as safe for use in the country, as well as provide drug relief for patients who suffer from adverse drug reactions as a result of off-label use.

Hsu Chien-wen (喋??, deputy director of the Food and Drug Administration’s division of drug and new biotechnology products, said that as no drug is 100 percent safe, doctors are advised to continue monitoring patients’ progress while they are taking them.

She said DOH officials would invite experts to discuss drug relief assistance and compensation.

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