In the Forum
BiDil Heart Drug Causes Lupus
BiDil was launched yesterday with a lot of news coverage as the first FDA approved drug for Blacks only. Heralded as the fore-runner of the personalised medicine revolution, the much mentioned pharmaceutical has stumbled at the first hurdle.
It now appears that the drug may cause the very painful systemic autoimmune disease generally known as Lupus but more properly termed Systemic lupus erythematosus. The disease already affects one in 250 black women. Dr. Johnatan Sackner-Bernstein, one of the original FDA advisory panel, expressed his concern that an instruction should be distributed with BilDil to advise a bi-annual testing regime for Lupus development.
Dr. Daniel Wallace, at the Ceder-Sinai Medical Center in Los Angeles, USA, suggested today that the principle risk is of patients who fail to make the connection between the medicine and symptoms characteristic of the onset of Lupus.
Interestingly, the generic form Hydralazine which is also FDA approved is accompanied by FDA advice that the patient should be tested for Lupus before commencing treatment and periodically afterward.
The disease affects Black women more than it does men. It appears that the benefits of BiDil may still outweigh the risks, and as always, it is down to individual medical professionals to make decisions regarding each individual case.
This case raises concern over the extent to which information and packaging is controlled by the FDA, and why suitable advice was seemingly not present to accompany this newly released drug. Further questions must be addressed to NitroMed, the distributor, who are enjoying a much improved share price since the launch.
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| Tests may need to be carried out for lupus every 6 months |
Sources: Seattle Times, Business Wire, Los Angeles Times, Orlando Sentinel
