Drug Safety Tracked Even After Approval, FDA Says

* Agency has required 385 postmarket studies since 2008

* New safety information led to changed labels 65 times

By Debra Sherman

ATLANTA, April 21 (Reuters) - The U.S. Food and Drug Administration said on Saturday it now spends as much effort and resources on surveilling a drug after it is approved as it does in the pre-approval process.

The FDA was responding to critics who say the agency is toothless when it comes to tracking the safety of drugs already on the market, when industry funds that supported pre-approval reviews tend to dry up.

"We think we've really balanced this," Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told reporters attending the Association of Healthcare Journalist meeting in Atlanta.

In a report released on Saturday, the FDA says it has required companies to do 385 post-market studies since 2008, and to change the label based on new safety information 65 times.

Before 2008 the FDA could not compel label changes or require additional safety trials and had to rely on voluntary action from drugmakers, she said.

The FDA's focus on post-market drug safety comes after the agency was sharply criticized as being slow to respond to drug side effects, notably Vioxx, a painkiller that Merck & Co Inc pulled five years after approval because of a link to heart attacks and strokes.

A 2006 report from the Institute of Medicine, an independent research body that advises the government on scientific matters, found the FDA needed to do more to police the safety of medicines after they reach the market.

Congress later gave the FDA more power to oversee drugs after approval, such as ordering companies to change their labels or conduct additional safety trials, and fining them if they fail to do so.


SENTINEL

But critics question how often the agency actually follows through on penalties.

In 2008 the FDA also launched Sentinel, a computer tracking system designed to help identify problems with drugs and medical devices already on the market by searching various databases for possible side effects - rather than just relying on voluntary reports from companies and patients.

The FDA said it used the system to see if there were negative drug interactions for Chantix, the smoking cessation drug manufactured by Pfizer Inc, but did not find any.

Last November U.S. researchers said Chantix carried too many risks and should only be tried when other treatments fail.

The findings, which Pfizer said were flawed, contradicted two studies released in October by the FDA that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged those studies were flawed because they were too small to identify rare events and captured only cases severe enough to land people in the hospital.

Woodcock could not immediately provide examples of where Sentinel alerted the agency to safety information they had not been aware of before.

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Comments

[carolxzhu]

11:36 AM on 04/27/2012

I hope the FDA really does follow through. How many times do we find out about a side effect after its already too late?
http://www.newsinferno.com/pharmaceuticals/tekturna-label-changes-valturna-market-withdrawal-announced-by-novartis/36884

[Jaideep Gajerawala]

05:40 PM on 04/23/2012

Actually I remember watching a video about Vioxx not long ago, that the FDA employee that released the heart attack link to it, stated his manager was very angry with him that he would do that. That it was his job to protect the business and not the consumer.

[Jaideep Gajerawala]

05:37 PM on 04/23/2012

I wish this was even partially true, maybe I wouldn't have 15 different health problems that were caused by 5 pills of Levaquin mfg. by J&J. A relatively helpful antibiotic with nasty side effects, which was handed to me when I didn't need it according to medical records and many other safer ones could of been used.
After 5th pill I had burning, tightness in leg muscles, weakness in arms. My leg muscles deconditioned over the months, and arches collapsed on both feet. Dry Eyes, Floaters in vision, tinnitus, chronic tendinitis in right arm, heart palpitations, muscle spasm.

Within minutes of googling Levaquin I found thousands of people complaining of wide spread damage to their bodies as a result of the medicine.

FDA has received over 20,500 complaints. There are 2700 lawsuits against J&J for LEvaquin and their argument is FDA has not advised us to change our label so we dont' have to.

Over the past year, I've spent nearly $10,000 out of pocket, and have had no answers besides muscles have failed. I have no disease that could of caused this, and even went to some of the best hospitals in the country with no answers.

FDA & JNJ are aware of these as many have complained, and their answer back is "we are too busy, if congress asks us to research then it will become priority"... They have done nothing to inform doctors.

[Andy Shick]

02:35 PM on 04/23/2012

This is not news. What's called Stage IV investigation has been going on for years.

[pdubpablo]

01:53 PM on 04/23/2012

LOL Like i would trust anything the FDA says about anything.....

[docter79620]

12:40 PM on 04/23/2012

I am interested if they track the effects of Mercury in our children's vaccinations? Isn't autism like 1 in 88 children these days?

I also wonder if the FDA did any follow up on the Bayer Pharmaceutical "mix-up" where they discovered that some of their pain medications actually had AIDS in them. Google : (Bayer drugs contained AIDS) The FDA denied sales in the US, so Bayer sold the AIDS infected drugs to Europe, Africa, and South America. If you don't believe me look it up. There is a great short documentary about it on youtube from a local news outlet. Trust your FDA and BigPharma! And keep arresting medical marijuana patients. The rich people gotta make more profits!

[Tony Baja]

12:56 PM on 04/23/2012

good post, but from my understanding, I believe I had read somewhere, as to most all asprins are manufactured offshore nowdays, and if not, then the ingredients are manufactured offshore, then sent here to the USA for production.

Scarey to think, that this problem was corrected with proper FDA oversight for offshore manufacturing, but the legislation was recalled under a new majority in congress....

oh yeah, I'm sure glad I take Exedrin! ---- Yikes, I did the research, and Exedrin is made by Bayer -- gulp!

Thanks for the tip, and I'll be choosing my asprins a bit more wisely.

[Tony Baja]

12:29 PM on 04/23/2012

I forgot, here's the link to the story about the Lack of FDA oversight on medications and supplements made in China........ But China is doing their best to fix this, they are just new at the game and so the products are sold in the USA, and if the USA wants to monitor it, then it's fine with China, the problem is, the USA just doesn't really care........Obama corrected this problem, but the gop congres than 2 years later overturned the FDA upgrades into China, and so the story goes..........
here's the link
http://www.huffingtonpost.com/2012/04/23/china-tainted-drugs_n_1444926.html?ref=health-news&ir=Health%20News

[Tony Baja]

12:25 PM on 04/23/2012

but the FDA only tracks medications made in the USA, and I believe about 60% of our medications are made offshore now (China, India, Mexico etc.) and they do NOT monitor those medications, they leave that up to those countries to do their own monitoring...... just look at the article about China and where a company was using industrial waste to make gel caps..... NO MENTION of the FDA (but without many questions asked, those products were shipped to the USA).
and well, so the story goes.

[Axlotl]

12:19 PM on 04/23/2012

Good; that is the best alternative to unacceptably long clinical trials, or insufficient testing.

[Tony Baja]

12:50 PM on 04/23/2012

what is an unacceptably long clinical trial?
Is that a clinical trial within the USA military, where there are NO FDA regulations because they might need an emergency type vaccine, and there are NO tests for long term side effects.
The long trial time, I believe is to test for long term side effects, and I think it is a smart thing, compared to the numbers above that needed to be retested, possibly becasue of Long Term Side Effects.

Then to lump unacceptably long term clinical trials with insufficient testing, has me amazed.
My opinion, an insufficient test, would be a test, that did NOT test, for Long Term Side Effects..........................just my opinion, based on this article about some problems with the products in China...... and that article is right below this article, for testing purposes;
http://www.huffingtonpost.com/2012/04/23/china-tainted-drugs_n_1444926.html?ref=health-news&ir=Health%20News

[Axlotl]

09:29 PM on 05/27/2012

An "unacceptably long trial" is a trial where a drug, of which the benefits clearly outweigh the risks, takes far too long to become available due to bureaucracy. It's self explanatory if you use your head.