The medication in question is called “Northera,” and it’s made by Chelsea Therapeutics International Ltd, a North Carolina-based biopharmaceutical firm. Northera is designed to treat a serious and rather rare form of low blood pressure typically associated with significant neurological disorders, including Parkinson’s disease.
Tests have shown that Northera is quite effective early in the treatment cycle. However, there are questions about its long-term effectiveness. Several experts have raised concerns about significant gaps in the clinical data.
Given these concerns, the Food and Drug Administration approved Northera on an “accelerated” basis — meaning the drug will become available and that follow-up tests will be carried out to ensure it poses no significant threat to patients.
The FDA will also be issuing a special label that warns Northera users of the risk of supine hypertension, which can result in increased blood pressure and even cause a stroke.
The danger is most visible when someone taking Northera lies down immediately after taking the drug. That’s why the FDA says “it is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses.”
Chelsea Therapeutics has struggled to get Northera on the market. The FDA initially rejected the drug in 2012 before asking for new tests and additional data.
