In times of economic hardship, low-cost generic drugs can be lifelines. They make it possible for people to continue critical medications. Without them, people could die.
But if generic drugs don’t meet quality standards they might be killing people themselves. This is the horrifying prospect that was brought to light by a recent review of the FDA’s own drug database.
The Institute for Safe Medication Practices (ISMP) is an independent nonprofit organization dedicated to reducing medication errors and dangers. It has just issued its most recent analysis of medication safety problems reported to the FDA.
According to ISMP, “More than 1000 patient deaths have now been reported in connection with the recall of 800 million digoxin tablets manufactured in New Jersey by the Actavis Group. The tablets were recalled because of the possibility that the strength of tablets was greater than labeled and might provide a potentially lethal overdose to patients taking the drug to aid failing hearts.”
To our knowledge, this is the first time that deaths have apparently been linked to problems with generic drugs. The ISMP concludes, “It is increasingly clear that the nation is experiencing serious problems in insuring that generic drugs are manufactured with adequate quality control.”
The heart medicine digoxin is tricky to use because the dose has to be just right. It can’t be too high or too low. Yet half the nation’s supply of this life-saving generic medicine was recalled last year because the dose was excessive.
Digoxin is not the only generic drug that has gotten into trouble. Other generic heart drugs including some forms of the rhythm regulator propafenone and the angina medicine isosorbide have also been recalled.
We have heard from readers who have had problems with certain generic blood pressure pills containing metoprolol succinate, bupropion antidepressants and some formulations of the antiseizure medicine levetiracetam.
Here is just one story: “My 18-year-old daughter switched to the generic brand of Keppra (levetiracetam) a couple of months ago. ‚Ä®Her seizures have been under control with ‚Ä®Keppra for more than a year, but she was on her own and opted for a cheaper brand.
“While taking this generic, she has‚Ä® experienced breakthrough seizures. ‚Ä®She recently moved back home and her last seizure happened in the‚Ä® shower this past Sunday. She fell out of the bathtub, convulsing on ‚Ä®the floor.
“I have never seen a seizure of hers that was as intense or ‚Ä®lasted as long. I took her to the emergency room because she complained of a massive ‚Ä®headache, accompanied by throwing up. I brought the medicine with me ‚Ä®to the emergency room and noticed the change on the prescription.”
The FDA insists that all generic drugs are identical to their brand name counterparts. But the ISMP report casts doubt on that claim.
Patients who would like more details on the pros and cons of generic drugs and guidelines for using them safely may wish to order our Guide to Saving Money on Medicine.
Until the FDA improves its monitoring of generic drug quality, physicians, pharmacists and patients will all need to be more vigilant.