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Medication used for blood pressure which has never been clinically proven to help patients, despite it being in widespread use for 14 years, could be withdrawn from the supply chain in the US.
Shire Laboratories has never submitted evidence to prove the effectiveness of ProAmatine, although the US Food and Drug Administration still approved it for sale in 1996.
ProAmatine apparently showed positive early signs in blood pressure treatment but Shire has never carried out “mandatory” trials which prove the drug’s benefits in the long term.
The FDA has now written to the Jersey-registered biopharmaceutical firm to tell it that it plans to take the medicine off the shelves – the first time the federal agency has used this threat because of missing clinical evidence.
It said the move to withdraw the drug “is necessitated by Shire’s failure to conduct post-marketing clinical trials that verify and describe the clinical benefit” of the drug.
ProAmatine is said to help raise very low blood pressure and generic versions of it, phenylephrine, are sold by several other companies.
Copyright Press Association 2010
US Food and Drug Administration
