Federal health regulators are pushing to recall a blood pressure drug that has been on the market for 14 years, despite the manufacturer's failure to submit evidence that it actually helps patients.
The Food and Drug Administration approved Shire Laboratories' drug ProAmatine in 1996 based on promising early results in treating low blood pressure. But the company has never submitted a mandatory follow-up study to actually prove the long-term benefits of the drug.
In letter to the company posted online Monday, the FDA proposes holding public meetings to discuss removing ProAmatine from the market. The letter marks the first time the FDA has threatened to pull a drug off the market due to missing follow-up data, though it has long held that power.