Is It Safe to Use Generics?

You get your epilepsy prescription refilled, open the bottle, and see that the pills look different this time. A quick look at the label tells you that instead of the brand-name medication you’re used to, this time you received a generic. Does it matter?

For most people, it shouldn’t. By law, generics have to have generally the same amount of usable -- you might hear your doctor say bioavailable -- medication in each pill as brand names. They can’t have less than 80% of what brand names have, and they can’t have more than 125%.

They’re Not for Everyone

But if you have “brittle” epilepsy, in which your body reacts strongly to very small changes in the amount of medication in your blood, the difference between 80% in one bottle of generic medication and 125% in the next bottle of generic can cause problems.

Some people can’t tolerate generics. Others are allergic to something in them. “It’s a sensitive topic because one seizure can set a patient back. It can prevent them from driving for 6 months or it can radically change what they’re capable of doing,” says Linda Selwa, MD, professor of neurology and codirector of the epilepsy program at the University of Michigan.

“Generic-to-generic switching is what makes epilepsy doctors and patients nervous,” says Jacqueline French, MD, professor of neurology at New York University’s Langone Medical Center. It’s most risky for people who need to keep their disease under tight control.  

French has other concerns with generics, like how they look and what kinds of extra ingredients (or fillers) are in them. “A generic pill doesn’t look like the brand name. A lot of them are just gray pills. If you’re taking three or four different pills, there’s a greater chance you’re going to get it wrong when filling your pill box,” she says. “Generics also have different fillers, and they may release the medication from the capsule at a different rate.”

New News Is Good News

Selwa says the debate about generic epilepsy medications has been around for a while. “This is an old controversy with medications and an old one called phenytoin (Dilantin). There were papers from [about 10 years ago] that indicate some patients who had to switch formulations more had more seizures.”

Continued

Newer research about other epilepsy drugs is a little more reassuring. One study published late in 2015, the Bioequivalence in Epilepsy Patients (BEEP) study, looked at the differences between the generic drug lamotrigine and its brand name form, Lamictal. The study compared how the medications were absorbed and processed in the bodies of 34 people in three different ways:

  • Brand name to generic
  • Brand name to brand name (different versions of Lamictal)
  • Generic to generic

The patients had frequent tests to see how much medication was in their blood. The researchers saw that while a few people had trouble going back and forth between drugs, only one patient had major problems with seizures.

The question was whether their bodies processed the drugs in the same way. They did, says Barry E. Gidal, PharmD, division chairman and professor of pharmacy and neurology at the University of Wisconsin-Madison School of Pharmacy. 

Gidal says there was one surprising result. “They also showed that taking the brand-name drug showed a fair amount of variability.”

In other words, there are no guarantees the medication will be exactly the same every time you get a refill, even for the brand name. If your epilepsy is brittle, you could react to the difference and have a breakthrough seizure.

“The reassuring part is that they found the risks [of switching to generics] to be pretty small, [although] it’s not entirely clear how we can make predictions for individual patients,” Selwa says.

Another study, the Equivalence among Generic Antiepileptic Drugs (EQUIGEN) study, on which Gidal is a researcher, compared different generics to each other. The results were similar: Patients didn’t have any major changes in how often they had seizures or side effects.

If you can stay with what works for you, you should, Selwa says. “The best advice seems to be to stick with a single formulation, whether it’s generic or brand.”

Working With Insurance

If you’re taking a brand-name medication, one day your insurance company might decide it doesn’t want to pay for it anymore. What then?

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Ask for an exception. “If your doctor has good reason to believe your epilepsy is brittle and you will suffer harm by switching to a generic, he or she can try to appeal it to the insurance,” French says.

They can still refuse. If you have to switch to a generic, talk to your doctor about monitoring you closely, French says. “See if your doctor can do a blood-level test before and after the switch. If you find a generic you do well on, as long as your doctor measures the amount of drug that’s in the bloodstream, you can switch.”

After that, be consistent. “Develop a relationship with your pharmacy and see if they can always get the same generic. Don’t bounce from pharmacy to pharmacy looking for the cheapest medication,” Gidal says.

Check your pills right there in the pharmacy when you get them. “If they look different, ask your pharmacist if it’s the same thing you got last month,” Gidal says. If it isn’t, ask the pharmacist to write down what the medication is, including the lot number, so if there is a problem you can take the information to your doctor.
 

WebMD Feature Reviewed by Neil Lava, MD on January 15, 2017

Sources

SOURCES:

Jacqueline French, MD, professor of neurology, New York University Langone Medical Center, New York; chief scientific officer, Epilepsy Foundation, Landover, MD.

Linda Selwa, MD, professor of neurology and co-director of the epilepsy program, University of Michigan, Ann Arbor.

Ting, T. Epilepsia, September 2015.

Barry E. Gidal, PharmD, registered pharmacist; division chairman and professor of pharmacy and neurology, University of Wisconsin-Madison School of Pharmacy.

Privitera, M. The Lancet Neurology, April 2016.

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