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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.
Has anyone ever had trouble with diazepam? My daughter will have withdrawal symptoms for no apparent reason. We are titrating her down but have to go very slowly because she goes into withdrawal so terribly.
It is unfortunate that although we may have a bad reaction or tolerance for the generic version of many medications, insurance benefits will usually only cover the generic...leaving the patient with little choice. My family of four cannot handle a $48 out of pocket expense when insurance will cover the generic for $8 even if the results are less than optimal. I don't bother file an appeal because experience has taught me that road only leads to "no, no, no"
My daughter has had the same withdrawal symptoms, even when the dosage was increased, with Xanax. This started when she was given a generic. I would like to hear from other people to whom this happened.
I just encountered a bad experience with my 2 mg diazepam manufactured by MYLAN. They did not work at all and I felt like I was having withdrawal symptoms while taking this brand for just a few days. I did some research on MYLAN and found out that it doesn't work for many people. I also found out that the other brand that I was taking with no problems is IVAX. So it is important to know who makes the generic diazepam.
I was told that they covered the bad effects of some generic brands on the T.V. program The TODAY Show. Seems like the FDA is not doing their job over seeing the ingredients for these medications coming from China and other countries. We need to all lobby Congress to bring back into the USA the manufacturing of all of our medications! It is getting very scary not knowing what's really in these generic drugs!
The pharmacy I use changed my script for Wellbutran to the generic brand Bupropion XL. When I informed my Doctor of the change she wanted me back on the Wellbutran brand as she didn't trust the generic. Well in order to get the name brand it will cost ME $365. for a three month supply. Up until the generic brand became available the name brand cost me $50. for three months. Needless to say I have to stay with the generic brand.
Hi....When I first started on KEPPRA-(BRAND) in 2006, I was doing OK, then in the month of May, 2009, my doctor gave me a script which was filled by the pharmacy in the generic form. I took this medication (GENERIC) without realizing it was the generic and not the brand. The generic brand has since caused me to have more seizures than I had on the brand, seven times for a whole week.
This has affected me to the point where I needed help to bathe, after using the bathroom, remembering things etc. I also had excessive sleeping and shortness of breath.
Thanks for allowing me to share my reaction to this medication.
My husband started having seizures again after being given the generic Keppra. His neurologist insists we go back to brand name, which we will, BUT our cost will go from $30 every 3 months to $550 every 3 months! I've appealed to the insurance, to no avail...that is their policy.
TO:annie,Jennifer and pearl- The family of drugs you all are having the problems with are called Benzodiazepines. All the drugs in this family will have withdrawal symptoms when stopped suddenly, unfortunately, just swtiching to the generics of these drugs is to many people just like stopping them.
It has been my experience, and that of many people I've talked to-that these drugs aren't always equal in generic form, even if they don't bring on withdrawal symptoms. What makes this so bad is the withdrawal symptoms of Benzodiazepines can be very serious.
Another bad thing seems to be that the price difference in brand name and generics of the Benzo. family is large. When I have compared the prices of brand and generic, generic was about 1/3 to 1/4 of what the brand name would be.
One way to handle it might be to speak with your Dr. and possibly you can slowly wean off the brand and on to the generic. The problem with this is you are still left with the generic not working as well as the brand. Also taking more of the generic doesn't solve the problem-they just aren't equal, as has finally been coming out in the news about many generics.
We all have to be our own advocates, because it seems we can only count on ourselves and our family members anymore. Sorry to sound so political, but it is really just safe advice.
Besides diazepam (Valium) and Xanax, Klonopin, Librium, and
Ativan are also Benzodiazepines.