Sep 24, 2014, 6:28 PM ET By JIM AVILASERENA MARSHALL, NICK CAPOTE and SARAH KOLINOVSKY JIM AVILA More From Jim » Senior National Correspondent SERENA MARSHALL More From Serena » via NIGHTLINE
When Robin Lynn, who
suffers from depression, was prescribed a generic version of a popular
anti-depressant medication, she didn't think it was going to be a big deal.
"I thought that generic drugs
are the exact same thing as the name brand drug," Lynn said.
But after taking Budeprion
XL 300, a generic form of brand-name Wellbutrin XL, Lynn, who is from New York,
said she noticed over time that the drug wasn't helping.
"I would have a lot of
energy, but by middle of the day I would have no energy, I would crash, and it
wasn't really controlling my depression symptoms either," she said.
"My outlook on life was different in a matter of hours. I knew that was
just not normal, that’s not how things are supposed to be."
In 2007, Lynn went looking
for answers and reached out to pharmacologist Joe Graedon, who wrote the
best-selling book, "The People's Pharmacy," with his wife Terry
Graedon, and hosts a popular radio show. Around that same time that he heard
from Lynn, Graedon said he began to receive complaints about Budeprion XL 300,
with users reporting some intense side-effects not seen with using the brand name
drug.
"They were getting
very jittery. They were experiencing headaches. They were having stomach
problems, insomnia,
just a whole range of side effects, and it just wasn't clearing up their
depression the way the brand name drug was," Graedon said. "And some
of them even expressed suicidal thoughts."
"It was like getting a
shot of adrenaline first thing in the morning," Lynn said. "It would
make my hands shake, my heart would pound."
Eight out of 10
prescriptions written in the United States are filled with the no-brand name,
generic version of the drug prescribed by a doctor, and every year generic
drugs save American consumers more than $200 billion in prescription costs.
For years, Joe and Terry
Graedon were strong advocates for the use of generic drugs.
"We were huge
supporters of generic drugs, because you can save an amazing amount of
money," Joe Graedon said. "I mean a brand name drug for heartburn
or for depression can cost a couple of hundred dollars a month. The generic
might cost only $5 or $10 a month... So if they were identical, I mean, What's
not to like?"
But when hundreds of people
started writing in with their negative experiences with Budeprion XL 300, the
Graedons became concerned and contacted the U.S. Food and Drug Administration,
asking them to investigate.
"Pretty much we heard
nothing back," Joe Graedon said. “The FDA didn't seem very responsive to
our concerns."
So Graedon decided to take
the investigation into his own hands. He took the drug Budeprion XL 300 to
ConsumerLab.com, which independently tests generic drugs for universities,
businesses, hospitals and government agencies, and asked them to test how
Budeprion XL 300 dissolves, and whether it dissolves the same way as the
brand-name drug, Wellbutrin XL.
The FDA mandates that
generic forms of prescription
medication contain the same active ingredient as the brand name, but
the agency allows the generic version to use different inactive ingredients,
including binders to hold the pill together and time release agents to disperse
it.
pagebreak That dissolution
process was important with Wellbutrin XL and its generic forms because they are
"extended release" drugs. Every time-release drug has a mechanism to
distribute the active ingredient into a patient's system. The generic forms
aren't required to have the same mechanism as their brand name.
"What we found was
shocking," said Dr. Tod Cooperman, the president of ConsumerLab.com.
"The generic released its ingredient very quickly. In fact after just two
hours, 34 percent of the ingredient had come out into solution. The original
product had only released 8 percent at that time. ... so you're getting a burst
of medication coming out very early on with the generic that you shouldn't be
getting."
Such a huge early release
of the generic drug Budeprion XL 300 would mean the active ingredient would
spike and be used up quickly, leaving little of the active ingredients in a
patient’s body for the rest of the day, while also potentially causing
unexpected side-effects.
After publishing their
results, Cooperman said, "it seemed like the FDA kind of wanted to quash
this issue. The manufacturer also questions, you know, did we do the right
test? The FDA said everything was fine."
The drug information insert
that comes with Budeprion XL 300 stated that the drug had been "tested in
a study" and "equivalence was demonstrated" with the name brand
Wellbutrin XL, but then, the FDA announced a shocking admission.
"The FDA finally
admitted that there actually had never been a study of this generic, and it had
never been tested in humans, and that the information in that package insert
was therefore, just made up," Cooperman said.
As it turns out, the FDA
did require testing in a lower dose of Budeprion XL and used those results to
approve the 300mg-strength version.
Janet Woodcock, the
director of the Center for Drug Evaluation and Research at the FDA, told ABC
News that the 300mg version wasn't tested separately because "there was
concern about testing the generics in normal volunteers."
"We had had seizures
reported, and we were worried that we would be unethically exposing
volunteers," she said.
But Cooperman believes the
FDA made an error in not doing further testing.
"If you're going say
'OK it's good enough for 300 million people to take it potentially, but we're
not going to test it in 24 healthy people,' I can't follow that
rationale," he said. "I think they made a big mistake there."
Five years after the Graedons'
first complained to the FDA, the agency took Budeprion XL 300, the 300mg
version, off the market in 2012.
"It was not equivalent
enough to the brand drug," Woodcock said.
Manufacturers for the drug
declined ABC News' requests for comment. Other forms of generic Wellbutrin are
still on the market, and they are all considered safe. In fact, experts agree
that generic drugs are in general extremely safe.
But there have been other
cases of generic drugs causing different effects in patients. Dr. Harry Lever,
a cardiologist and the medical director of the Hypertrophic Cardiomyopathy
Center at the Cleveland Clinic said he starting seeing patients having problems
with a generic form of Toprol XL, a blood pressure medication.
"They began getting
chest pain or shortness of breath or dizziness. And some of them I would just
change the manufacturer back to the name brand... some would seem to feel
better," he said.
Lever wrote to the FDA
about his concerns in December 2012. He received an assurance, 18 months later,
that all forms of generic Toprol were up to the FDA's standards. But then, just
two weeks later, the FDA announced two forms of that drug manufactured in India
were voluntarily recalled.
According to the FDA, the
recall was "a coincidence." Woodcock said these recalls were routine
and due to some specific lots that may have degraded over time. Dr. Reddy's
Laboratories Ltd., one of the companies that manufactured the drug, also told
ABC News that the voluntary recall was "related to specific manufacturing
issues with the two batches in question and not related to manufacturing of any
other batches."
But Lever isn't buying it.
"All I can speak to is
what I'm seeing," he said. "And I've seen problems and when you have
batches that are removed you begin to wonder that there are problems and you
can't just ignore it."
Though watchdogs like
Graedon and Cooperman believe most generics are safe, they still have concerns
about others.
“We suspect there are at
least dozens if not scores of generic drugs that may not live up to the
standards that the American public expects,” Graedon said.
The FDA disagrees. Woodcock
told ABC News that the FDA stands "behind the fact that generic drugs that
are on the US market have delivered the same performance as the brand
drugs."
The bottom line is generic
forms of prescription medication, while generally safe, are not identical to
their brand-name drugs, though critics suggest using caution and speaking with
your doctor.
http://abcnews.go.com/Health/questions-raised-differences-brand-rx-drugs-generics/story?id=25729595&singlePage=true
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