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No Substitute: When a Generic Drug Isn’t What it Seems

Generic medications are generally safe and effective, because the Food and Drug Administration requests tests to prove they’re equivalent to the name-brand originals. But here’s a case where something went wrong.

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Wellbutrin XL alongside the generic version Budeprion XL (Getty Images)

Andrew Richards remembers that he had just sat down in front of the TV when the lightning bolt struck. "It was almost like it went through my ear because I could hear it. It was kind of like, 'fwomp,' right through my head," he says.

Stunned and disoriented, Richards tried to get up, he says, but spasms rumbled through his torso and his back; his muscles kept clenching and relaxing. He doesn't recall falling. "It was almost like a little piece of time was missing, almost like a record skipped ahead a little bit," he says, "like I was sitting on my couch and time had moved forward and I was on the floor."

The next thing Richards remembers was calling out to his wife, who scooped him up and drove him to the emergency room. He would soon discover that the lightning bolt that struck him down was an electrical storm taking place entirely in his brain: a seizure. Less than a year later he was in court, contending that his seizure -- and the spasms that he says still plague him -- were caused by a faulty generic medication.

Generic medications are generally safe and effective, because the Food and Drug Administration mandates tests to show that they are equivalent to the name-brand originals. But in 2011, the Food and Drug Administration determined that a major laboratory had committed such “egregious” research violations that years’ worth of its tests — many comparing generics to name-brand drugs — were potentially worthless. The FDA has required drug manufacturers to redo many of the tests from that lab, owned by the now-defunct Cetero Research. But a ProPublica investigation shows that the agency took little action to prevent consumers from taking medicines the FDA no longer knew for sure were safe or effective.

Richards’ suit involved a drug that was not tested by Cetero. But his case spotlights the possible dangers of a generic medication that isn’t actually equivalent to the name-brand original.  

The drug Richards took is Teva Pharmaceutical USA's 300 milligram version of extended-release buproprion -- an antidepressant better known by its brand name, Wellbutrin XL. Shortly after Teva's generic Wellbutrin was approved by the FDA in 2006, patients began to complain that the drug wasn't working as well as the name-brand version. Some contended that it was causing more severe side effects.

Richards says he suffered his seizure in March 2008 after his pharmacy switched him to the Teva generic. Within a few days of starting the new pills, he says, he started to experience jolts and jerks. "Sometimes when you're falling asleep, you get what's called a sleep start," Richards says. "Well, I would get that but I was awake." Then the seizure hit.

Despite having stopped taking Teva's drug, Richards says he continues to have spasms several times a day. Richards, who was a lead plaintiff in a lawsuit against Teva, contends that it was a direct result of his taking Teva's generic Wellbutrin. The suit ended in a settlement in which Teva did not admit fault. Teva and Richards won’t discuss the financial terms, but a judge’s ruling approving the settlement suggests that it was for $4.5 million, the vast majority of which went to legal fees and costs.

Neither Teva, nor Impax Laboratories, which manufactures the pill, have admitted that there was anything wrong with the pills. "The product was approved on the basis of the bioequivalency testing that we were required to perform at the time," said Marc Donohue, Impax's Senior Director for Corporate Communications. "There had never been a safety issue with the product." Teva did not answer questions about the Wellbutrin case.

"Just after [Teva's generic] went on the market, within 6 to 8 weeks, first there was a trickle, then half a dozen, then a dozen letters," says Joe Graedon, a consumer health advocate and author of "The People's Pharmacy," a syndicated drug advice column. After writing about the potential problems, the complaints became so numerous that Graedon commissioned his own study to test Teva's pill side by side with the original. The finding: As the pills dissolved, the generic version wasn't acting the same way as the name-brand. "The Teva generic releases much faster -- much, much faster -- than the name brand," says Tod Cooperman, president of ConsumerLab, the company that performed the test.  "There's this huge burst that occurs right away."

Faced with doubts from consumers, the FDA first defended the drug. In April 2008, the agency stated that Teva's generic was "bioequivalent and therapeutically equivalent to... Wellbutrin XL." The FDA dismissed complaints of ineffectiveness and side-effects as being consistent with the ups and downs of depression.

Still, the FDA asked Teva and Impax to conduct a study to clear up any doubts. Teva terminated the study after recruiting only eight patients. "It was because of slow enrollment," says Impax's Donohue, who said that the protocol required subjects to stay in a clinic for 24 days, which likely scared off potential participants.

The FDA picked up where Teva left off, and by August 2012, the agency’s own study showed that the two drugs weren't equivalent. This forced FDA to reverse its position; in October 2012, the agency declared that Teva's generic is "not therapeutically equivalent" to the original.

The FDA declined to comment.

The announcement heartens Richards, but one thing he regrets, ironically, is that he'll never again be able to take even the brand-name version of Wellbutrin, which he says was tremendously effective in treating his depression. "Everything clicked into place. Everything felt normal again," he says. But, he says, his doctors now warn that taking any form of Wellbutrin is out of the question. "I actually asked them if I could go back on the brand, but the damage was done."

Every MS DRUG needs to be SCRUTINISED and whos dealing them also

Mary L. Grabski

April 15, 2013, 1:34 p.m.

I’ve known for years that many generics are not “identical” to the drug they are copying, as we are led to accept and believe.  Years ago, I was on Provera, as part of my HRT.  Every time I was dispensed the generic, I would have breakthorough bleeding, and had to get the actual brand name pill.  It happened numerous times, even though my prescription specified the name brand, so it was not imagination, though I had no way of knowing WHICH one they dispensed, until I started bleeding.  If it happened with one medication, I’m sure it happens with many others, probably with disastrous effects, not just inconvenient bleeding.  Just the cheap ways we cheat our patients for selfishness and greed.  Lazy inspectors, cheapened rules, money here and there, under the table, are all guesses how this happens.  Bribery is supposed to be illegal, but only a rare person ever gets charged, compared with the millions of times it is committed.

Not surprised to read that Teva is the generic manufacturer. It seems to pop up in more research about side effects than other drug companies. Had a personal experience with their product. Fortunately, the pharmacy changed to a different manufacturer for what I need. Side effects immediately changed… for the better. I will avoid anything manufactured by Teva in the future.

The only trouble with this story is that bupropion itself, under the name of Wellbutrin, is famous for seizures as a side effect. If the patient has any tendency toward seizures, whether they’re aware of it or not, bupropion is likely to bring them out. Of all the antidepressants out there, Wellbutrin is the top one to avoid in anyone with seizures.

Less-than-useful, even harmful, generics are a worthy subject for investigation and discussion, but in this case I think overlooking the drug’s propensity for seizures in its name-brand form is pretty dishonest.

Verticalpharmacy

April 17, 2013, 4:37 a.m.

Each patients should consult his doctor before switching to Generic Version of his medicines. Precaution is always better then cure.

It strikes me as a heck of a coincidence that only the generics are unsafe.  It almost seems improbable, given the problems the big companies have had with tainting, the rubber-stamping the FDA’s contractors have done, and the business tactics companies like Pfizer have used to (probably illegally) force generics from the market.

I don’t want to imply anything specific, since I don’t know any details, but I will say that if I were a company reliant on limited-term patents that guaranteed my income and I had no ethical or moral sense, I might be inclined to have people blow whistles on the companies producing generics to direct their sales to my product.

Not that the generics companies shouldn’t be monitored.  They should, of course.  But it seems like these recent articles are designed to imply that the big companies deserve our unquestioning faith and “knockoffs” are somehow dangerous by definition.

(Part of the problem, as well, is that drug patents are worthless.  They should specify the drug in enough detail that someone can replicate it, not leave the generics manufacturers scratching their heads.  Patents are primarily for “We the People,” so to speak, not the company that gets protection.)

A similar thing happened decades ago when Dilantin went generic.

Patients switching from the brand name to the generic immediately had increased and more severe seizures. New patients on the generic had no problem. In about a year, retesting showed that what patients were reporting was true: Dilantin and the generic were not equivalent.

I recently got a prescription filled on a drug I have regularly taken for years.  I am actually fine with the generic version, but in this instance, I noticed when I went to pick up the medication that the pills were a different shape and had a different generic manufacturer listed on the bottle label. 

I took it for two days and had very alarming side effects.  I called the pharmacy (a shout out to Walgreens actually) and explained what was happening. 

The pharmacist did not say they had other complaints but the speed with which she called back and fixed the problem, led me to conclude I wasn’t the only one that had called.  She said they had never used the manufacturer before but she had less than a months supply still available of the older manufacturer’s version which she gave me and then called my insurance company and had they credit my account for less than a months supply.

I will agree with your Statements..

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