Federal regulators on Friday unveiled a high-tech system to restrict distribution of Accutane, a drug that has been particularly effective against severe acne but has long been known to cause birth defects and is now being studied for a possible connection to the suicides of teens.
Patients, doctors, pharmacists, wholesalers and manufacturers all will be required by the Food and Drug Administration to enroll and participate in an Internet-based tracking system primarily designed to ensure that women don't get pregnant while taking Accutane.
Women of childbearing age will be required to submit the results of monthly pregnancy tests, and all patients will have to acknowledge that they understand the potential for psychiatric side effects, which will also be emphasized in stronger warning language.
The FDA's new tracking system, called iPLEDGE, will go into effect Dec. 31. Wholesalers, pharmacies, doctors and patients will have to register with the system to sell, prescribe or take Accutane and its generic versions. Patients will be able to register on the Internet or through a special toll-free number.
Although welcomed by some experts, the FDA actions are unlikely to satisfy critics who say the agency has neglected its duty as a drug safety watchdog. Accutane has been on the market for many years and these critics say the measures the FDA has finally taken will not keep doctors from prescribing it to patients who may not need such strong medicine.
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Patients, doctors, pharmacists, wholesalers and manufacturers all will be required by the Food and Drug Administration to enroll and participate in an Internet-based tracking system primarily designed to ensure that women don't get pregnant while taking Accutane.
Women of childbearing age will be required to submit the results of monthly pregnancy tests, and all patients will have to acknowledge that they understand the potential for psychiatric side effects, which will also be emphasized in stronger warning language.
The FDA's new tracking system, called iPLEDGE, will go into effect Dec. 31. Wholesalers, pharmacies, doctors and patients will have to register with the system to sell, prescribe or take Accutane and its generic versions. Patients will be able to register on the Internet or through a special toll-free number.
Although welcomed by some experts, the FDA actions are unlikely to satisfy critics who say the agency has neglected its duty as a drug safety watchdog. Accutane has been on the market for many years and these critics say the measures the FDA has finally taken will not keep doctors from prescribing it to patients who may not need such strong medicine.
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