FDA investigating generic seizure medications

by: Jim Strickland Updated:

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ATLANTA - The vast majority of the prescription drugs in your medicine cabinet have not been tested on patients to see if they work. That is because those drugs are generics, and their testing standards are vastly different from the brand-name drugs they copy.
           
Eighty percent of the drugs sold in the United States are generics.

Channel 2 consumer investigator Jim Strickland spoke to doctors and patients who say some less expensive generic medicines can have a dangerous downside.
                       
"My eyes roll up in the back of my head.  My body goes stiff.  I start to shake.  I don't remember any of it," said epilepsy patient Stephanie Boswell of the Morningside neighborhood in Northeast Atlanta.
           
On Sept. 7, a seizure hit Boswell, a board member of the Epilepsy Foundation of Georgia,  just after she pulled into her driveway with her husband and three kids in their minivan. 
           
"Where was that car, 5 minutes before this happened?" Strickland asked.
           
"On the interstate," she said.  The danger of a seizure behind the wheel is why Georgia law requires epileptic patients be seizure-free for six months before driving. 
           
Michelle Gasaway of Spaulding County broke two ribs falling from a seizure in the shower. 
           
"You don't know until you do experience it how scary it is," she said.
           
The women had been seizure-free for years taking brand-name medicine. Boswell had been on Lamictal, Gasaway had been taking Keppra, and medication made by UCB, Inc. of Smyrna.
           
Their seizures came days after each woman starting taking a generic copy.
           
Strickand asked epileptologist Lawrence Seiden, MD, if generics are equal to the brand-name anti-seizure medication.
           
"No. It's really a pretty simple answer," he said.
           
Seiden, another Epilepsy Foundation board member, says anti-seizure drugs are uniquely complex. 

They are part of a family of medications called Narrow Therapeutic Index drugs. Blood thinners and thyroid medications are also considered NTI drugs. 

Seiden says variances in generic copies are too risky for epileptics. He demands insurance pay for the brand name.
           
"I have to do what's safest. I'm not going to take the cheaper, half-assed alternative just in case it's as safe," he said.
           
Dr. Roger Williams, who heads the nonprofit research institute U.S. Phamacopeia, takes a different view.
           
"Can we draw a conclusion that it's the generic's fault?" asked Strickland.
           
"No. You cannot,” Williams said.
           
USP laboratories are responsible for setting drug quality standards used across the globe. Williams said since a generic pill copies a brand name whose active ingredient has  already been tested for effectiveness, the generic just has to prove it gets ingested properly.     
           
Healthy volunteers take the pills, not patients. 

The Food and Drug Administration said the shortcut saves Americans $10 billion a year at the pharmacy. 

The FDA evaluates testing done by the pharmaceutical companies themselves.  FDA's own testing is rare. 

The FDA is conducting its own tests on the generic drug Boswell was taking before her seizure.

(Read Jim Strickland's full list of questions to the FDA and its response here.)
           
"I trust the companies and I trust FDA," said Williams, a former top level administrator with the agency.
             
"You've got to have some faith. Now, is it perfect?  It's never going to be risk-free. No drug is risk-free," said Williams.
           
"The FDA says, 'Trust us. We know what we're doing. They're equal, they're identical. Everything's fine.' That may not be as true as they would like it to be," said pharmacologist, author and national radio host Joe Graedon.
           
Last October, the FDA pulled a generic anti-depressant from the market five years after Graedon first warned regulators about a spike in complaints that the drug didn't work.
           
FDA is also on record saying that 80 percent of the active chemicals and 40 percent of all pills come from foreign factories that can go 13 years between inspections.
           
"I think it imposes a burden on FDA to make sure they inspect everywhere," said Williams.
           
The number of complaints versus the number of pills sold is small.  The generic industry is also now paying user fees to fund faster approvals and more foreign factory inspections. 

There are 2,000 foreign and domestic factories on the inspection list.  FDA figures by 2018 it will be inspecting every other year.  

The agency declined to appear on camera.

 

Helpful links:

FDA generic medicines information

FDA release on Wellbutrin

The People's Pharmacy

Generic Pharma Association

FDA Q&A with Jim Strickland


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