C/P:
It is estimated that 150 million people world-wide may have the Hepatitis C Virus. On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir (Harvoni; Gilead Sciences) for the treatment of patients with chronic HCV genotype 1 infection. Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as, the first approved regimen that does not require the use of interferon or ribavirin.
The FDA approved the drug under breakthrough therapy designation, which is intended to expedite the development and review of drugs for serious conditions.
The FDA, in their own reporting system of adverse events (FAERS), show numerous reports of sudden death, respiratory failure, renal failure, cardiac failure, hepatic failure and as well as hundreds of reports of a myriad of other problems, yet the public hears none of this and doctors are denying problems.
One can go on any blog to read statements from patients taking or who have taken the drug and are reporting multiple problems beyond those stated by Gilead
To include, but not limited to, long-term problems of tinnitus, severe neuropathy, joint pain, muscle pain, constant headache, chronic fatigue, heart issues, lung issues, vision problems etc
A letter to the FDA asking them to inform the public of these problems resulted in a response that they informed the public about deaths resulting from an interaction with the drug Amiodarone, which causes a slowing of the heart. .
How can this be the only information provided to the public?
What about those families who have lost loved ones taking only Harvoni, and the many who report long-term problems and decreased quality of life? The drug has been on the market since October 14, 2014; and the only warning is an interaction with Amiodarone?
How many more have to die, be crippled or have loss of quality of life before the public is informed?
I personally now suffer from a multitude of problems more than a year post treatment with much decreased quality of life, as do many others.
Although “virus free,” I, and many others would not have taken Harvoni had we known the potential additional dangers to our health. The prescribing physician told me it was safe.
The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices etc.
