Here in Miami, I'm betting this list is news to many - not to mention folk living elsewhere in the country. However, there it is online and ready for viewing on the FDA's website: the Adverse Events Registry Service (AERS ), where drugs that might be dangerous are listed. That's right -- they're not recalled, they're not pulled from the stores, but they ARE listed here for possible bad juju as reported by someone who had a very bad experience with the prescription drug or over the counter medicine.
The AERS - Adverse Events Registry Service - Reports of Bad Drug Experiences Every Three Months
Online, the federal government is giving you notice of possible bad drugs or OTC medicine by listing reports coming in over a three-month period. Here's the list of medications from April to June 2010 (the latest one available when this post was published):
- Clindamycin injection (Cleocin)
- Dronedarone hydrochloride (Multaq)
- Etonogestrel implant (Implanon)
- Everolimus (Afinitor)
- Febuxostat (Uloric)
- Ferumoxytol injection (Feraheme)
- GnRH Agonists (Androgen Deprivation Therapy)
- Lanthanum carbonate (Fosrenol)
- Omeprazole products
- Simvastatin (Zocor)
- Saquinavir mesylate (Invirase)
- Tapentadol hydrochloride (Nucynta)
- Tetracycline products
- Trastuzumab (Herceptin)
These things sound pretty serious: hallucinations (Nucynta), convulsions (Implanon), "Serious cardiac disorders," (Feraheme) - whatever that means. Wow.
FDA Warns About Its Warning
Of course, above this listing there's lots of verbiage explaining things like "[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk." Not to worry, right?
Because, the list just "...means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk." Testing, testing, testing for that causal link - gotcha.
And, of course: "... [the] FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate."
Obviously, the FDA has lawyers, too.
Meanwhile, once again please remember that a drug is simply a product entering into the marketplace from a for-profit manufacturer. It can be defective, just like a child's car seat or a car's tire. There are laws in place to protect you and your loved ones from defective drugs -- but most importantly, if you or someone in your family has a concern that an over the counter medication or a prescribed drug is not doing as it should, then get to a doctor and get things checked out.
Be careful out there. It's not smart to be paranoid, but it's equally foolish to be too trusting of a drug these days.
By on November 4, 2010 2:30 PM
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