National saline shortage affects Louisianans

National saline shortage affects Louisianans
Updated: Nov. 29, 2017 at 7:30 PM CST
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BATON ROUGE, LA (WAFB) - Jessica Schexnayder has a neuromuscular disease called multifocal motor neuropathy (MMN), a variant of chronic inflammatory demyelinating polyneuropathy (CIDP). "It's basically the immune system eating away at the nervous system," explained Schexnayder.

Since 2012, she's been getting plasma antibodies, or IVIG infusions, at home once a month, but since her disease has progressed, the treatment is now required every two weeks. "Those antibodies keep my immune system from attacking my nervous system," Schexnayder said. "The plasma is very thick. The consistency is very much like Karo syrup."

Schexnayder, a patient advocate for the Guillain-Barre syndrome CIDP Foundation, says sometimes the body can react negatively to the plasma. To prevent that reaction, she needs saline, the small volume sterile IV solution that's manufactured by Baxter in hurricane-damaged Puerto Rico. U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. says Baxter's sodium chloride 0.9 percent injections bags, also known as mini bags, are "used to provide fluids and medicines to patients across the United States."

Schexnayder says she found out about two weeks ago that her regular monthly supply would be reduced to one bag per shipment. Baxter says three manufacturing sites "sustained minimal damage from Hurricane Maria. However, the damage to Puerto Rico's electrical and transportation systems continue to present challenges."

"I was scared because I have to have the saline prior to my IG," Schexnayder said. "For me, it prevents something called aseptic meningitis, which is an inflammation of the brain and the spinal cord which can sometimes happen when plasma is infused," she said.

So a dependable saline supply is pivotal for Schexnayder, along with dozens of people in south Louisiana who need regular infusions. But now, her shipment doesn't arrive until about a day or two before her next infusion, putting Schexnayder just a little on edge.

In the meantime, her home health company has made a few changes. The product still comes from Puerto Rico, but a pharmacist in the United States is now hand-filling each bag. Baxter says they "remain focused on helping ensure patients have continued access to the products and therapies they need. Restoring reliable supply remains our collective priority."

The company says they have activated a "global response" to recovering following the hurricane. "To this end, we have been working with FDA and have been gr anted regulatory discretion for temporary special importation of certain products from Baxter facilities in Ireland, Australia, Canada, Mexico, and England to help support product supply for the U.S. market. These products include our MINI-BAG Plus Container Systems, small volume parenterals (SVPs), amino acids, and certain premixed products. In Puerto Rico, we make small volume parenterals, which are primarily used in the pharmacy to compound or admix a medication or to aid in the delivery of medication."

They expect to return to normal supply levels by the end of the year for several products manufactured in Puerto Rico.

The FDA says they're working with Baxter to "monitor the challenging situation on the island. The agency is also continuing its work with other manufacturers on steps to prevent or mitigate shortages of other types of critical medical products."

Click here for more information on the GBS CIPD Foundation and support groups in the area.

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