When I started writing about pharmaceuticals 50+ years ago, I was one of the country’s most ardent supporters of generic drugs. At that time, brand name medications dominated the marketplace, but I was convinced that people could save a lot of money by requesting generics whenever possible. I even debated a Big Pharma representative on Good Morning America. In those days I completely trusted the Food and Drug Administration to guarantee generic drug quality. Over the intervening decades, though, I have heard about far too many generic drug failures. I believe the FDA has let us down. In some cases, poor-quality generic drugs could be life threatening.
When Are Generic Drug Failures Dangerous?
The Food and Drug Administration states that:
“Currently 90 percent—9 out of 10—of all prescriptions dispensed in the United States are for generic drugs.”
The agency maintains that all FDA-approved generic products are “…safe, effective, high-quality drugs…” We are not so sure. More about that in a moment.
For many generic drugs it may not matter if they are a perfect match for the brand name. I do not worry very much about generic diazepam (Valium), for example. A little more or a little less of the active ingredient is rarely an emergency. Ditto for the pain reliever celecoxib (Celebrex).
We have heard from quite a few people that generic celecoxib does not always work as well as the brand name. You can read their stories at this link. At last count, over 300 people have commented about this problem, but for most of them it is not a life-threatening situation. Many complain that their arthritis pain comes back, but they are still functional.
We view generic drug failures as critical when it comes to antibiotics like doxycycline for Lyme disease or Rocky Mountain Spotted Fever. If the generic drug does not work, it could indeed be life threatening. The same could be said for medications that are prescribed to prevent organ rejection. If someone gets bad tacrolimus, they could lose their new kidney and ultimately their life.
Generic Drug Failures and Epilepsy:
I consider epilepsy a condition that requires perfect quality. This parent describes a worrisome outcome associated with generic Keppra:
Q. My 7-year-old child had not had a seizure in four years. Her epilepsy has been controlled with Keppra and the ketogenic diet.
Recently, she was switched to levetiracetam, the generic form of Keppra, and now the seizures have returned.
I am so disappointed and worried. How can I get the pharmacy to dispense name brand Keppra?
A. Many others have complained on our website that generic versions of Keppra were less effective than the brand name. Here is a link to an article I wrote a few years ago:
Generic Drug Recall Linked to Deaths
One person with epilepsy was well controlled for years on Keppra. After being switched to the generic form she had several seizures within two weeks. She noted, “this was life threatening since I fell down stairs and also had a seizure while cooking.” After her doctor insisted on Keppra, her seizures were once again controlled.
We brought this issue to the attention of the FDA 15 years ago. Officials told us they were investigating, but it could take some time. As far as we can tell, the agency has never responded.
We are not the only ones to complain about generic levetiracetam.
An article in the Annals of Pharmacotherapy (May, 2011) reported similar problems:
“Patients reported an increase in seizure activity to their neurologists after treatment was switched from Keppra to generic levetiracetam formulations. To confirm the timeline of increased seizure activity with use of the generic drug and report these adverse events to MedWatch, we made a telephone call to each patient’s pharmacy to collect information on dispensing dates and the generic formulations’ manufacturers. Subsequent to the increase in seizure frequency with generic levetiracetam, treatment in all 4 patients was switched back to Keppra. Seizure frequency in all patients returned to baseline when Keppra was reinstituted.”
Generic Drug Failures Still Happening:
If you were alert you noticed that the date on the article above was 2011. We received a tremendous number of similar complaints around the same time. That is because before levetiracetam became available, most patients had to take the brand name Keppra. They could tell the difference quite quickly.
These days, most people with epilepsy do not have the “luxury” of starting treatment with brand name Keppra. Therefore, they have no way to compare brand name to generic.
Avoiding Life-Threatening Generic Drug Failures:
Here is a message about avoiding generic levetiracetam by purchasing brand name Keppra from Canada:
Q. My doctor prescribed Keppra and Tegretol for my epilepsy. I do not want to take the generic forms, so I buy the brand name products from a Canadian pharmacy. Three months of Keppra is about $900 there and Tegretol about $200.
In the US, they would be $4,176.00 and $1,567.00 for three months respectively, so I save about $4,600 over that time.
I have had no problems with the Canadian pharmacy, and they usually source these brand name drugs from the UK. I do have to plan ahead, though, to allow for shipping time. I thought others could benefit from my experience.
A. We have heard from many readers that switching from brand name Keppra to the generic anticonvulsant levetiracetam may lead to breakthrough seizures, so we understand why you have chosen to stick with the brand name.
Because the brand-name medicine is so expensive in the US, a more affordable Canadian pharmacy makes sense. Not all online pharmacies that claim to be Canadian actually are legitimate, though. To verify, look for the provincial pharmacy license number on the website. There also must be a physical address in Canada. A certification seal from CIPA (Canadian International Pharmacy Association) is also reassuring.
We summarize this and much more information about ordering from legitimate Canadian pharmacies in our eGuide to Saving Money on Medicines. This online resource can be found under the Health eGuides tab on this website.
Share Your Story:
Have you had good luck with generic drugs? If so, please provide the details in the comment section below. Have you had problems with generic drugs? We would like to read your story as well. People who comment can remain anonymous, so no worries in that regard. If you have had success with an online Canadian pharmacy, we would also like to read about your experience.
