GET THE FACTS BEHIND THE NEWS
The Ortho Evra case is the latest in a series of failures to protect he public against the serious health hazards of powerful medicines. This situation has caused experts and others to question the Food and Drug’s commitment, and the present Federal Administration’ s commitment to protect and preserve the nation’s health.
It was six years after the companies’ own researchers found that the Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, even before Ortho had been approved by the FDA, At last six years later the public was notified.. In the six-year interval, the larger amount of estrogen increased the risk of blood clot’s and strokes. The Food and Drug Agency received reports of at least 50 deaths associated with the drug according to an article in the April 6. 2008
New York Times.
In addition it appears that the Ortho people deliberately camouflaged the increased estrogen by reducing the actual figures by 40% .This correction was mentioned only once in a 435 page report to the FDA and then in a complex mathematical formula according to an April 14, 2008 New York Times article..
3,000 Women and their families have sued Johnson and Johnson claiming that ORTHO EVRA patches caused heart attacks, strokes, and in some cases death.
How could this happen? Why didn’t the FDA catch this error and do something about it?
In Blog 2,3,4 and 5 we discuss several other hazardous mistakes. by the FDA. In Blog 6 we have a brief look at the FDA and its support from the Federal gov’t. Blog 7 explains how the Johnson Co, makers of Ortho, are trying to avoid any legal and financial responsibility for the deaths and illnesses caused by the larger estrogen dosage.
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