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Failing To Report Severe Drug Side Effects: A National Embarrassment


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"Chances are that many readers of this column have had an adverse drug reaction or have a family member who has suffered from a similar situation. One estimate published in 1998 in theJournal of the American Medical Association said that adverse drug reactions ranked somewhere between the fourth and sixth-leading causes of death in the U.S."

"That report, based on data from the mid-1990s, didn’t lead to the sort of change that many hoped. You might think that 20 years later, in an Internet age with powerful information technology tools in so many hands, that drug side effects would routinely be reported in detail, and in real-time.

Nope. Only about 500,000 reports were sent to the FDA in 2010, about one-tenth of the estimated number of serious adverse drug reactions. Things have improved somewhat in the past couple years, as there were about 700,000 such reports of hospitalizations, life-threatening situations, and other severe adverse reactions, according to FDA data. But under-reporting is still the norm. If my dad hadn’t asked his doctor to file a Medwatch report two weeks later, I’m confident he would have been among the vast majority of patients whose severe side effects would have gone unreported.

The post-market safety surveillance system is a mess and always has been. Doctors are busy, and they already have plenty of paperwork. The FDA doesn’t have the resources to do truly rigorous post-market safety surveillance, so it concentrates most of its energy on reviewing data from controlled clinical trials before it allows a drug on the market. The pharmaceutical industry is required to pass along reports of serious adverse events to regulators, but it has always treated this as a cost and a low priority. Lately, the industry has sought to cut costs on drug safety monitoring by outsourcing work to India, as was described recently in the Wall Street Journal."

"One systematic review that attempted to measure the magnitude of under-reporting found that across 37 studies, in 12 countries, the median under-reporting rate was 94%, according to results published in 2006 in the journalDrug Safety. Another review published three years later in the same journal found that under-reporting of adverse events was mainly caused by physician ignorance, the fear of looking ridiculous for reporting merely suspected adverse drug reactions, procrastination, indifference, insecurity and complacency. In a twisted bit of logic, the researchers found that many doctors didn’t report adverse events because they figured the FDA only allows safe drugs on the market. Apparently these physicians fail to realize that regulators need to get their data points from somewhere."

"Given my job as a biotech journalist, I’ve known about systemic weaknesses in adverse event reporting for a long time. I’ve written about the problem. But it’s one thing to write about in the abstract, and another thing when one of your loved ones is affected by those systemic weaknesses."

"Luke Timmerman is the founder and editor of Timmerman Report, a subscription publication for biotech insiders."

This is a 3 page article that I have cherry picked for information jut enough to get you to look I hope...more at the link


Had a car accident in 85
Codeine was the pain med when I was release from hosp continuous use till 89
Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year
Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above.
One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking.

As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. 


There is a crack in everything ..That's how the light gets in :)

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