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The
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The
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By Megan Flaherty
A silhouette of a pregnant woman with a slash though her rounded body appears on every thalidomide pill, warning of the devastating birth defects caused by the drug. The image on the pill shouldn't come as a surprise to patients taking thalidomide. The Food and Drug Administration (FDA) says thalidomide will be one of the most tightly restricted drugs ever marketed in the United States. As part of the program regulating its use, patients must be thoroughly educated about the drug that caused missing or flipper-like limbs and other serious birth defects in thousands of babies around the world 40 years ago. To receive a prescription for thalidomide-which was approved in July for treatment of leprosy-men must agree to use condoms and women must agree to use two forms of birth control. Patients taking
thalidomide must register with the Slone Epidemiology Unit at Boston
University, which will monitor patient compliance and report to Celgene
Corp., the New Jersey biotech company marketing the drug, under the
trade name Thalomid. Physicians prescribing thalidomide and pharmacists
dispensing it must register with Celgene. "We've tried to establish
a closed-loop system where if there are any failures, we would be notified,"
said John W. Jackson, Celgene's chair and CEO. Not
prescribed casually There are fewer
than 100 cases of leprosy in the United States, but scientists and health
professionals say thalidomide may also be prescribed to treat conditions
related to AIDS, cancer, and other diseases. Nurses should be
prepared to answer questions from individuals wondering whether thalidomide
would help them, Gallagher said. "We need to understand the risks
and give adequate counseling about the potential good and bad of the
drug," she said. "It's not just patients. You have to include
the whole family or the partner." An AIDS patient considering taking
thalidomide would already be receiving significant counseling, Gallagher
added. "You'd be counseling them about the risks of transmission.
These risks would be included in a long list" of topics to discuss,
she said. Overcoming the past For the first 90 days after FDA approval, only 2,000 physicians and 2,000 pharmacies will be allowed to register with Celgene to prescribe and dispense thalidomide, Jackson said. Eventually, any physician and pharmacy can register, he said.
"Regulatory
protections haven't lessened, but there's a greater public acceptance
of the realities," Myers said. People are willing to take a drug
if they're being monitored, he said. "These are very positive developments.
In the past, a lot of patients wouldn't have had access to these drugs." A new model The FDA has required the manufacturers of two other teratogenic drugs-Accutane (isotretinoin) for acne and the newly approved Rebetron (a combination therapy of ribavirin and interferon alfa-2b) for chronic hepatitis C patients-to monitor their use in women of childbearing age. However, patient participation is voluntary.
The thalidomide program is mandatory. And thalidomide is also unique because it is the first drug that has been tightly controlled for prescription and dispensing, said Sandra Kweder, MD, deputy director of drug evaluation at the FDA. "We feel very confident that the thalidomide model of restricted distribution is a good one," she said. "I don't know that there are other drugs currently in the pipeline that have that level of risk. We're lucky there aren't that many out there," Kweder said. "Thalidomide has the additional hurdle of its own history, and we don't have many of those either." |
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