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.

Join Over 53,000 Subscribers at The People's Pharmacy

Each week we send two free email newsletters with breaking health news, prescription drug information, home remedies and a preview of our award-winning radio show. Join our mailing list and get the information you need to make confident choices about your health.

  1. svo
    Reply

    I was using Dr. REDDY Celexa generic. One time they changed it to torrent because they didn’t have Dr. REDDY it was horrible. Within a few weeks I was having horrible anxiety. Doesn’t work.
    I went back on Dr. REDDY and everything was great after a few weeks. It was like I wasn’t even taking it when I was on the Torrent.
    Pharmacists told me today they discontinued Dr. REDDY. So they started me on Cambridge. Praying it works good.

  2. Ann J.
    Reply

    I had been using citalopram by Torrent for 2 months but got this new batch and I also am out of the country and have a 6 month supply. Two days after starting the new batch I had a severe headache and stomachache and then the depression returned. I had been great for 6 months. I doubled the medicine but it did nothing but make me feel awful.
    I feel there is a problem with this batch. I’ve had to go to a Dr. here to try a different generic because that is all they have on this island. I’m devastated and discouraged. I guess this needs to be reported to the FDA.
    I was so happy to read your post and I’m sorry you are having problems also. We rely on these medications. I can’t believe companies can be so irresponsible when our lives depend on these medications. Wonder how they would feel if it was their family member that needed it.

  3. aj
    Reply

    Have been using Torrent Pharma Citalpram for a month but with my last refill my old symptoms are back nearly full force. I’m out of the US and have brought a 6 month supply with me. It is a big concern. I wondered if anyone else had this problem. I have an awful stomach ache and headache with this new supply. I started feeling bad 3 days after I started this new batch. Seems like there is a problem with this batch. I’ve increased the dose wondering if the problem is the ineffectiveness of the dose.

  4. BH
    Reply

    I had horrific side effects from 5mg diazepam from Walgreen’s Mylan labs brand, orange pills. The first time I took them, I woke up feeling like I was being shocked or as if I were having a seizure. I thought the plugs behind my bed that had a fan and an alarm clock plugged into them had shorted out and into my bed or my hand or some part of my body. This kind of reaction occurred at least 5 times.
    I felt like I was having an out of body experience on several occasions as if I floated up out of my body and into my dining room on one occasion.. I felt like I was half awake and half asleep, trying to come back into my body, trying desperately to wake fully up again, again, as if I were having some sort of seizure. Again, as I said on these occasions, I also I felt as if I were being shocked by A/C electricity.
    Obviously I stopped taking them and have moved to another pharmacy at another store. Beware of these pills. I have taken Diazepam on many occasions and never experience anything like what these pills did to me. It should be noted that all or almost all pharmaceuticals or their ingredients come from China or India or some other country, especially the generics. BE CAREFUL!!!

  5. Kay
    Reply

    I also had a great deal of nausea & dizziness when my pharmacy switched to Camber P. from a previous generic (not sure which one).

  6. dp
    Reply

    My wife also had side effects when she got Torrent Citalopram instead of the other brand she had been using. Her side effects included vertigo (dizzyness), aches, headache, and much more. Seemed like the pills were wrong or subpotent. Now there is a recall on a lot of Geenstone citalopram because it may contain the male baldness/chemotherapeutic drug finasteride.

  7. jag
    Reply

    I believe I had a bad reaction to citalopram 40mg manufactured by Torrent Pharmaceuticals. I have taken Celexa and citalopram (the generic) since 2001. In early 2009 I moved, and the new pharmacy supplied the Torrent citalopram. The following 5 months I was about 60% incapacitated with all over joint and muscle pain, weakness, stiffness, and fatigue.
    I had LOTS of blood work done with normal results. In September, a new pharmacy gave me another brand generic manufactured by Forest Labs (I think the parent lab of Celexa) and within HOURS I had a pleasant familiar side effect; pleasant because I hadn’t realized it was ABSENT; minor jaw clenching, always an indicator to me that the drug was working. Within 24 to 48 hours the pain was gone, and I regained my strength and well being within weeks.
    I don’t know if something was MISSING or I had a problem with an inert ingredient. At any rate, I’ve taken this medicine long enough that I’m certain there was no placebo effect; I didn’t even know the lab was different until I had the favorable “side effect”. I gave my doctor all details so he could help any other patients affected by this.
    Please be aware that there could be individual effects of formulation. Since Anti-Depressants can take weeks to kick in, and people are trying to eliminate other variables in the interim, the possibility of ineffective or deleterious generics should be considered.
    Sincerely,
    June

  8. Star,C.M.A. (Moderator)
    Reply

    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.

  9. bbm
    Reply

    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.

  10. ENRIQUE V.
    Reply

    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.

  11. R.A.
    Reply

    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.

  12. pearl
    Reply

    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!

  13. Jennifer
    Reply

    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.

  14. tammy w
    Reply

    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”

  15. annie
    Reply

    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.

What Do You Think?

Share your thoughts with others, but be mindful of protecting your own and others' privacy. Not all comments will be posted. Advice from web visitors is not a substitute for medical attention. Do not stop any medicine without checking with the prescriber. In posting a comment, you agree to our commenting policy and website terms and conditions.