Gadolinium, The Metal Dye They Use For MRIs

FDA Acts to Restrict GE’s Omniscan MRI Drug, and Two Others

by Jeff Gerth ProPublica, Sep. 9, 2009 6:28 p.m.

Sept. 10: This post has been updated.

The U.S. Food and Drug Administration said today that GE Healthcare’s Omniscan and two other MRI drugs should not be used in patients with severely impaired kidneys because they risk developing a rare but potentially fatal disease.

The decision marks a turnabout for the FDA and brings U.S. labeling requirements for Omniscan and the other drugs more in line with those in Europe, where an association first surfaced between Omniscan and the disease, nephrogenic systemic fibrosis, or NSF.

It also comes as a setback to GE Healthcare, which argued against special FDA labeling for Omniscan, and which faces hundreds of lawsuits from patients who contracted NSF.

ProPublica reported last year on GE Healthcare’s efforts to defend Omniscan, and on the company’s attempt to muzzle a Danish radiologist who criticized the drug.

Magnevist, the market leader, sold by Bayer HealthCare, and Optimark, which is sold by Covidien, are also affected by the FDA’s announcement Thursday.

Covidien last year acted on its own to contraindicate use of Optimark for at-risk kidney patients. But GE and Bayer continued to assert that their drugs were no riskier than the other so-called contrast agents, which are used to make MRIs easier to read.

The FDA has approved seven such drugs for use in the United States.

GE Healthcare and Bayer issued statements Thursday emphasizing their continued concern about patient safety and pointing out that tens of millions of doses have been used as diagnostic tools without any adverse effects.

GE said it would update Omniscan’s label to reflect that the drug should not be administered to patients with severe kidney damage. Bayer said it would respond to the FDA’s action within 30 days.

The first link between contrast agents containing gadolinium, a heavy metal, and NSF, a crippling condition with potentially lethal complications, surfaced in 2006. The next year, the FDA recommended a “black box” warning for at-risk kidney patients.

The agency decided to treat all the drugs as a class, ignoring two of its own medical reviewers, who said Omniscan was associated with a disproportionately high share of NSF cases and wanted to ban its use in patients with severe kidney conditions.

Since 2007, all contrast drugs sold in the U.S. have carried the same warning on their labels. Regulators in Europe, by comparison, acted that year to contraindicate use of Omniscan, Magnevist and Optimark in patients with severe kidney disease.

Amid continuing concerns about safety last year, the FDAconvened two advisory panels in December to look at the issue again. The agency’s scientists had done further research and concluded that warning labels for the three drugs should be made sterner.

The panels recommended a ban on Optimark and Omniscan. But while some panel members also voiced concerns about Magnevist, there was a wide range of opinions about what to do and no consensus.

The FDA normally follows the recommendations of its advisory panels.

More than 110 million doses of Magnevist have been sold worldwide, according to Bayer; GE Healthcare says Omniscan, the nearest competitor, has been used more than 48 million times.

All the manufacturers deny that their drug causes NSF. Omniscan has been linked to more of the reported cases of the disease than any other drug and has been named in more lawsuits than the other drug companies.

Since the disclosure of the disease the market share of Omniscan has fallen by about one half and the percentage of a less risky drug, MultiHance, made by Bracco Diagnostics, has risen, according to FDA data presented last December.

In addition to banning the three drugs for some, the FDA urged better screening to discover at-risk patients before using any of the gadolinium-based agents, which are administered intravenously, and closer monitoring of patients for signs of NSF afterward.

NSF has not been reported in patients with healthy kidneys, the FDA said. The disease, marked by scaling, hardening and tightening of the skin, or red or dark patches, can also cause fibrosis of internal organs that may lead to death, the FDA said.

New reports of NSF have virtually disappeared thanks to heightened awareness about the condition.

Update: Covidien has issued a statement in response to the FDA's action.

I just read about this through the Lyme Induced Autism Group. This is so scary. Yet another thing to get out of our bodies. Anyone needing an MRI probably already has problems? Another thing conventional doctors know nothing about. Chelation has such a bad name these days. People suffering with all sorts of problems, all from THIS!

Is Rudolph Real?

So we've had quite a Zen holiday. Usually, we go to California for holiday break. This means I must SSS (shop, ship, and stress) a couple weeks earlier. We also do Hanuka. House-sitters, mild climate clothing, and other logistics are a must but worth it. Last year Leo asked "Why don't we ever have Christmas in OUR house?" So I jumped on it.

Leo had begun questioning the validity of Santa just after his birthday (he received a globe and because he's a visual learner, he really "got" the concept of earth's rotation and our place in the solar system). Out of the blue, he states, "Hey Mom, I still believe in Santa, but I don't believe in Rudolph." Off I went with an Academy performance, chalking everying up to magic. He looked wearily at me, uncertain, but didn't bring it up again until about a week before the big day. Looking at me across the breakfast table, eating cereal (natch, GFCF organic), he says "Hey Mom, I think I know what I want to ask Santa for." Of course I'm thinking about all the gifts already purchased. I asked what, and he said "I want two things, first a real baseball bat made of wood that real players use. And second, a picture of the real Rudolph." He stares at me intently for my reaction, almost challenging me. I didn't know what to do! But then I began a story about how the real Rudolph's photograph is top secret, no one has seen him, just like the actual location of Santa's home and workshop. I told Leo he could ask, but Santa may say no. He seemed to buy it, mostly.

Leo had apparently taken notice of my several conversations about pianos, as Santa brought us a Casio-Key-Privia-Digital-Piano. Right after he woke up Christmas morning, he quickly ran back upstairs to tell me that Santa brought ME a piano, when in fact it was for them! Of course they couldn't care less about it, until two days later they became infatuated with all the sounds and the Bastian piano lesson guide. Now they both fight over the piano! And of course this is just the first week, so we'll see! And to my delight, Leo seems to have that ASD skill, an "ear" for music.

Surprisingly, we didn't miss CA as much as anticipated. Of course I spent about 4 hours on the phone Christmas day, and did have feelings of regret, but they were brief and infrequent. A week at home with just the 4 of us, well, it was unprecedented.

During the holidays, I take advantage of the time home (or at my sister's in CA)to do an annual detox for Leo. Because of his impaired GI and immune system, Leo cannot regulate organic and inorganic substances on his own efficiently, common with ASD, Down Syndrome, and other neurological disorders. Because of this, substances build up and eventually have a behavioral effect on Leo (spaciness, lack of focus, stims come back, lethargy, lack of curiousity). The test of time (4 years) has demonstrated that an annual detox helps minimize toxic load and build-up from the past year. And sure enough, Leo's dark circles have returned under his eyes (mild, but I can tell), the rigidity and focus on his preferred activities (football, soccer)has returned.

Leo is definitely an environmental kid (genes too, but), and this time of year we are reminded when these symptoms appear that yes, he has Autism, and yes, we must help him the best we can so he can feel his best. There are many days that go by that aren't Autism days. Just days with Leo, his uniqueness and all.

This time around, I'm attempting a different homeopathic protocol, and in total this should take about 3 months. I'm also doing this protocol right along with him so I can feel what he feels as much as a different person can. I also need this detox as well. We're aiming to go slowly with Leo so he would feel mostly well the entire time, and thus not affect regular life and school. As always with detox, there is a regression, a time where you really don't feel well since toxins are coming out of the tissues and organs and entering the circulatory system and eventually the lymphatic system and finally out. The pay-off in the end is renewed focus, energy, no dark circles, and increased health (details depending on the person).

So that's that!

School update: Nothing too exciting to report although to my surprise, he's no longer playing with The Best Friend every day at recess. This has been going on since Kindergarten, where they first met. They had different teachers for 1st grade, but preferred to play together at recess and their friendship continued. They are reunited again this year for 2nd grade.

Now, his Best Pal is really into Star Wars, something that Leo doesn't care about much. He also thinks his friend is "annoying about it", and whips out imaginary light sabers whenever possible, including music class and gym whenever the opportunity arises. He is also turned off by the fact that the Best Friend gets into trouble "a lot" in class, distracting Leo when he's trying to read or listen (both need undivided attention since he's not a natural multi-tasker).

To date, Leo prefers to play baseball with other kids in his class, along with one of the gym teachers pitching. Funny, how Leo works. He watched for the first couple of months, and finally had the courage to try it and risk failure in front of the entire 2nd grade class. He's still quite the perfectionist and now I see a competitive streak when it comes to sports. He really WANTS to be good.