This weekly column offers opinions on the latest pharmaceutical industry news.
Most Americans may assume their prescription medicines are packaged with the latest, up-to-date safety information. But that may not always be true when it comes to generic drugs.
The companies that make brand-name medicines can change their product labels when they learn about new side effects that may harm patients. But federal regulations prevent generic companies from doing the same thing, unless a change has already been made to the corresponding brand-name drug.
Generic drug manufacturers don’t mind having their hands tied in this way because it helps shield them from potential lawsuits over side effects not mentioned on their medicines’ labels. But it potentially jeopardizes patient safety. With generic drugs now prescribed the vast majority of the time, side effects often are first noticed in patients taking these medications.
I was taking the generic drug Simvastatin and it caused blindness in my left eye and left me with permanent vision loss in both eyes. After thousands of dollars in diagnostic tests it was found that the Generic drug caused the vision loss and damage to my optic nerves. AND THERE WAS NOT ONE WORD IN THE ADVERSE SIDE EFFECTS PAPER I GOT WITH THE MECICATION THAT SAID ANYTHING ABOUT VISION PROBLEMS AT ALL!. I tried to sue the drug maker NorthStar but the FDA blocked it stating that Generic drug makers do not have to list the dangerous side effects of their drugs and the FDA stands behind them. ” big money protects big money” and Now I sit here with permanent vision loss with no compensation while the while the poison maker poison make ran off with part of my vision and my money like a thief in the night. IN LIGHT OF THIS, I have dumped all my medications and will NEVER again take another pill. NOR will the hosp. put another big pharma drug in me. I WILL DIE FIRST!. If I need drugs again I will look on the street for them as I have never heard of a street drug causing blindness.
Thanks for the note. Not sure I follow, though, why you think this oversimplifies things. The FDA is still struggling with a backlog of generic applications. So it’s unclear how the agency could quickly devote resources needed for executing labeling changes. Presumably, the FDA would still be involved and oversee changes so they are synchronized.
This article over-simplifies the situation. We cannot have a variety of different labels for the same drug. The generics are reporting adverse events, and due to GDUFA, the FDA has a lot more resources to stay on top of the situation. And yes, the paper insert is a waste. MD’s check for prescribing information online now, and updated inserts are posted immediately upon implementation, rather than waiting for the next lot of drug product to be manufactured and labeled with the updated information, while there is still product on the market with the old information.
ALL PI inserts must be approved by the FDA before being used anywhere, whether online or in the packaging. Not sure what you are getting at. As far as having different labels for generics from different manufacturers? Simple answer: once the FDA approves a safety change for one maker’s label, all makers must then adopt that change. If they are all notified when a safety change is requested, they can all have their say before the FDA rules. They all know who their competitors are; requiring them to shoot a copy of the proposed PI change as they sumbit it to the FDA is no burden at all, on sender or receiver.
Very, very few, including doctors, pharmacists and patients, EVER reads drug “labels” (ie, package inserts). 99.999% are thrown away. The only ones reading them are attorneys. So it is if no concern whether or not generics list “all” the side effects (which is impossible, anyway). I have personally created and read hundreds of inserts with the full knowledge that all they are is a waste of paper.
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