Fayette County Clinic:
Washington CH, Ohio

Phone 740-335-6935
Crisis 740-335-7155

Floyd Simantel Clinic:
Chillicothe, Ohio

Phone 740-775-1270
Crisis 740-773-4357

Highland County Clinic:
Hillsboro, Ohio

Phone 937-393-9946
Crisis 937-393-9904

Lynn Goff Clinic:
Greenfield, Ohio

Phone 937-981-7701
Crisis 937-393-9904

Martha Cottrill Clinic:
Chillicothe, Ohio

Phone 740-775-1260
Crisis 740-773-4357

Pickaway County Clinic:
Circleville, Ohio

Phone 740-474-8874
Crisis 740-477-2579

Pike County Clinic:
Waverly, Ohio

Phone 740-947-7783
Crisis 740-947-2147

 

 


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Firdapse Approved for Rare Autoimmune Disorder

HealthDay News
by -- Scott Roberts
Updated: Nov 29th 2018

THURSDAY, Nov. 29, 2018 (HealthDay News) -- Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).

It's the first agency-sanctioned treatment for the autoimmune disease that affects the connections between nerves and muscles.

"Patients with LEMS have significant weakness and fatigue that can often cause great difficulties with daily activities," Dr. Billy Dunn, director of the FDA'S Division of Neurology Products, said in an agency news release. "There has been a long-standing need for a treatment for this rare disorder."

LEMS affects about three people per 1 million worldwide, the FDA said. The disorder most commonly occurs among people with cancer, such as small cell lung cancer.

The drug's safety and effectiveness were evaluated in clinical studies involving 64 adults. Those treated with Firdapse were found to have benefited more than those who took a placebo, the agency said.

The drug's most common side effects included a burning or prickling sensation, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache and elevated liver enzymes.

The agency advised any user who has a hypersensitivity reaction such as rash, hives, itching, fever, swelling or trouble breathing to immediately contact their doctor.

Firdapse is produced by Catalyst Pharmaceuticals, based in Coral Gables, Fla.

More information

The FDA has more about this approval.