Genric Drug Problem Raises Questions On Quality

For decades the FDA has maintained that generic drugs are every bit as good as their brand name counterparts. Millions of people rely on generics as less expensive alternatives to pricey products like Coumadin, Valium or Prozac.
Employers, insurance companies and HMOs are desperate to control the ever-escalating costs of prescription drugs. That’s why they have embraced generics and trust the FDA to guarantee equivalency. This means that a generic is supposed to get into the blood stream just the way the original innovator drug does and work exactly the same way in the body.
But is the FDA right in its assumption that generic drugs meet the same quality standards physicians, pharmacists and patients expect of brand name medicines? A new study suggests that the FDA may be overlooking some evidence.
The research, published in the journal Neurology (Oct., 2004), reports on a problem that was noticed in Minnesota soon after the state health plan mandated generic drug substitution. Epileptic patients who had been controlled for years began to have seizures that required urgent clinic or emergency room visits or even hospitalization.
Health care providers investigated eight patients who suffered serious seizures after being switched from the prescription antiepileptic medicine Dilantin to its generic equivalent, phenytoin. Blood levels dropped by roughly 30 percent when patients took generic phenytoin (made by Mylan).
The researchers concluded that switching patients to generic phenytoin could be penny-wise but pound-foolish. The small cost savings could be wiped out in a single hospitalization.
Readers of this column have been reporting trouble with generic drugs for years. One person had a similar experience to the Minnesota patients:
“I have been taking Dilantin for 16 years to treat temporal lobe seizures. About two years ago my pharmacist filled my prescription with the generic. I began to have seizure problems within a few weeks. That is when I noticed that I was using a generic.
“I called my pharmacist to ask about this and he said their policy was to fill prescriptions with generics unless requested not to. This must have been a new policy, because I had never received the generic before.
“The pharmacist gave me a refund for the generic and sent brand-name Dilantin. I now make sure to remind them each time that I need Dilantin, not the generic. I guess I did my own accidental study verifying that I had problems with the generic.”
When we contacted the FDA about this case and inquired about the Minnesota research, we were told the issue is being investigated. Meanwhile, millions of Americans may start wondering whether their generic drugs are doing what they should.
We have prepared a new Guide to Saving Money on Medicines that offers readers of this column some practical ways of assessing their generic drugs and other strategies for keeping medication costs under control. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons’ People’s Pharmacy, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027.