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FDA Approves First Medication Made With 3D Printing

PITTSBURGH (KDKA) -- Medicine puts 3D printing to work, making joint replacements, tissue and cartilage, skull, skin, and organs.

"There's always a group of people who are very interested in any sort of new technology," says AGH neurologist Dr. Andrea Synowiec.

The FDA has now approved the first medicine made with this technique. It will be called Spritam, and will be the same drug as the widely prescribed levetiracetam, brand name Keppra.

"The pill that they're printing is a highly used seizure medication," says Dr. Synowiec. "The way that it's described is that it's put together in a porous structure that makes it easy to dissolve."

With a special process, the drug's active and inactive ingredients are laid down layer-by-layer.

Some advantages include easier swallowing, having pills printed close to the patient and more quickly available, and customized dosing for patients who might have trouble figuring out the right amount given a combination of pills of different sizes and doses.

"This is a complete change in the way pills are currently manufactured. There's going to be a lot of economic and financial hurdles to overcome," points out AGH internist Dr, Marc Itskowitz.

What insurance companies will cover this is yet to be seen.

"They often determine, or help to determine, what patients are able to take, by how much it costs patients out of pocket," says Dr. Synowiec.

"The FDA will have to do a good job with quality control, making sure each printer is appropriate and working well," says Dr. Itskowitz. "I think initially it's going to apply to a real small number of patients, and a really small number of pills."

"It will be interesting to see as we go forward and more manufacturers start getting more approvals for new medications just what the impact will be to retail pharmacy," says Paul Higginbotham, an Allegheny Health Network pharmacist.

A drug company will be using the 3D printing method from its Ohio branch. The pills are expected to hit the market in early 2016.

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