Does generic anti-seizure drug have a flaw?

January 20, 2008 at 12:00a.m.

Q. I was taking phenytoin, an extended release generic form of the anti-seizure drug Dilantin. On Sept. 19, 2007, I had a grand mal seizure, and upon admission to a local ER, my lab results indicated my phenytoin level was UNDETECTABLE! It was not just low, it was actually 0.0!

I had been faithfully taking my 200 mg capsule at bedtime every night. In fact, I had just swallowed that evening’s dose right before the seizure.

I have reported this event to the Food and Drug Administration and the manufacturer. I have not been able to find out if the capsules were authentic or counterfeit.

I would encourage anyone taking phenytoin to have labs done to ensure you have an adequate level of the drug in your system. I am still taking the generic for seizure control because my insurance company mandates it. I have my phenytoin level checked monthly, however, to ensure that each bottle is actually providing an active ingredient.

A. Several years ago, there was an article in the journal Neurology (Oct. 26, 2004) documenting that an extended-release generic phenytoin provided less active drug than the brand name Dilantin. Patients in Minnesota had been switched to the generic as a condition of their state employees health insurance. Several experienced seizures after the switch.

The FDA tells us that it is investigating this issue, but it has not issued an official report. In the meantime, your advice to monitor blood levels of phenytoin seems very sensible. No one should have to risk a seizure because of a flawed formulation.

Anyone who has had a problem with generic drugs may share the experience online at www.peoplespharmacy.com and with the FDA at www.fda.gov/medwatch.

Q. I’ve read about the difficulties of disposing of unused drugs and want to share my solution. I poured Elmer’s glue into the pill container to cover the pills and let it set before putting the container in the trash.

A. That sounds like an innovative solution for the problem of drug disposal. Thanks for sharing.

Q. My doctor recently put me on Fosamax once a week for osteoporosis. A few days later, I was in terrible pain with my arthritic thumbs. They hurt so much that I wanted to cut them off.

I called my doctor, and he put me on Actonel once a day instead. The pain in my thumbs has subsided, but now I have pain in my lower back and hip that I never had before.

I am 67 and in good health. Is the pain I’m getting caused by either of these drugs?

A. The FDA recently issued an alert about side effects associated with bisphosphonate osteoporosis drugs such as Actonel, Boniva, Fosamax and Reclast. The agency says there is a “possibility of severe and sometimes incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates.” Perhaps you are susceptible to this complication.

Not everyone can tolerate this type of osteoporosis medication, but there are other ways to reduce the risk of weak bones or fractures. We discuss several different sorts of medicines and nondrug approaches to osteoporosis prevention in our book “Best Choices From The People’s Pharmacy.” It is available in libraries, bookstores and online at www.PeoplesPharmacy.com.

X In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of The Vindicator or e-mail them via their Web site: www.PeoplesPharmacy.com. Their newest book is “Best Choices From The People’s Pharmacy” (Rodale Books).