FDA

New lung imaging system announced

Thanks to Dr. Ian Taras for this interesting item.  An Israeli company has gotten FDA approval to market a new lung imaging device that works without radiation.  The device evidently uses the vibration of air to image the lung in real time.  The company says the potential uses include imaging in the ICU, and tracking lung cancer.  The device may be targeted to doctors' offices.  Enjoy!

 

Abbott device safe, effective for leaky heart valve treatment

This undated photo illustration made available by Abbott Laboratories shows the MitraClip mounted on the end of a catheter. The clip, a fabric-covered The big story from American College of Cardiology this week: the Abbott mitral valve clip may be as effective as open heart surgery to fix leaky mitral valves.  Certainly seems less invasive.

The valve clip is not available in the US, so perhaps this clinical trial result will move the device in the direction of an FDA approval.

Skeleton in the closet: Fosamax and hip fractures

New evidence showing potential safety problems with fosamax, particularly implicating the medicine in hip fractures.  FDA is said to be reviewing the information.

Millions of people are taking fosamax.  The perception among my patients is that it helps them build bone, though the numbers suggest it mostly prevents further bone loss and prevents fractures.

So which one is it, does Fosamax prevent or cause fractures?  We will have to rely on the FDA to find out.

FDA urges caution on topical Voltaren

Podcast file: 

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Even though there is less absorption of the drug into the circulation, even topical diclofenac (Voltaren gel) has the potential to cause liver damage.

This was the subject of a "Dear Doctor" letter from the FDA in December 2009, and it was a topic highlighted by this month's Worst Pills.org.

Avastin is a miss in gastric cancer

Remember 2007?  That was the year Avastin was going to set the world on fire.  There was improved survival success in colon cancer, then lung cancer.  Avastin was on a tear.

Improved survival is an easy sell to the FDA.  The survival advantage wasn't huge, but it was statistically reproducible, and so the benefit of helping people with advanced cancer live longer made this new treatment attractive.

FDA, public comments, and REMS programs

I have long maintained that the FDA REMS programs mainly serve the purpose of big drug companies looking to avoid class-action litigation, while they limit access to drugs and create additional administrative tasks for clinicians.

REMS Programs place undue burden on clinicians

Dr. Jenkins--

I have seen your recent comments on providing REMS programs for opioids. Since you are the director of OND, I was hoping to give you some feedback on these programs, and to alert you to the adverse effect on patient care that they can have.

I am a clinical hematologist and oncologist. I have to contend with many drugs under these programs, including Promacta, Nplate, Thalomid, Tysabri, and Revlimid. Looks like opioids are next on the list.

Ear candles...yes, ear candles

Oh dear.  You don't see these two words together that much. 

I laughed out loud with this one, in WSJ today.  Evidently there are enough peophttp://www.dragonflywellness.com/images/candles.jpgle gullible enough to buy a big candle to stick in their ears to require a warning from the FDA.  FDA says it's probably not a good idea to stick a huge hollow candle in your ear to draw out earwax--we here at InteractMD.com would tend to agree.  Key problem: burns from hot wax from the candles.

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