Updated 3/14/00
After more than a year, the FDA has denied the citizen petition by terbutaline pump supporters (including Dr. Fung Lam, who is considered to be the father of the terb pump). The supporters sought a review of the FDA's position on the pump. The FDA warned in 1997 that the pump was neither safe nor effective for long-term use.
After a review, the FDA maintained its position. In its response, it says: "FDA reaffirms the position stated in its "Dear Colleague" letter that there is no evidence of the effectiveness of prolonged treatment with subcutaneous terbutaline to manage preterm labor and that there are significant safety concerns associated with unmonitored, long-term administration of the drug."
The terb pump supporters made several other requests in their petition, all but one of which were denied. First, the pump supporters asked the FDA to notify the people who received the 1997 warning letter that terbutaline is as safe as ritodrine and that the deaths of patients who received terbutaline were not due to the drug. (Ritodrine is the only FDA-approved preterm labor drug and is a cousin of terbutaline.) Second, the supporters wanted the FDA to ask terbutaline manufacturers to remove warnings against using terbutaline for preterm labor. These warnings are on package insert statements. The supporters also wanted the FDA to "acknowledge that it has restricted physician choices" in preterm labor drugs by issuing the 1997 warning. The pump supporters also sought an acknowledgment that the FDA has placed "unwarranted liability" on physicians by issuing its 1997 warning.
The only request that the FDA said it would honor -- if such an occasion arose -- was to expedite approval of pending preterm labor drugs.
Text of FDA response to petition
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