Today’s Los Angeles Times reports that the “FDA Minimized Issue of Lotronex’s Safety — Times study finds officials sided with drug maker on regulatory concerns. Agency reevaluation is underway.”
According to the report, five people taking the drug Lotronex have died and yet the drug has only been on the market for eight months. As many as 49 others have suffered from potentially life-threatening complications, according to the report.
According to the report, the drug hit pharmacy shelves in March, and in April reports of “serious side effects” began to be filed by doctors. Yet the makers of the drug don’t think it is dangerous and want to mass market it to more people, according to reports.
A drug company representative reportedly said the following: “I think there is a great duty not to over-warn. We have to put the risks and benefits of all these products in proper perspective.”
The Times asked why this drug was approved so quickly when it is not a life-saving medication. To that a representative reportedly said that “We can’t not approve drugs because they have certain side effects.”
The same rep reportedly also stated, “they’re all going to have side effects. We have to determine, are they going to be adequately managed?”
L.A. Times: FDA Minimized Issue of Lotronex’s Safety
Related Article: Drug Found Effective But Side Effects Include Death
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planetc1.com-news @ 8:25 am | Article ID: 973182337
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