We continue to receive complaints about generic medicines. Many are made in countries where the FDA does not have an adequate number of inspectors. Often the FDA staffers do not speak the native language and require interpreters. Even more worrisome, the FDA often has to alert the company weeks or even months in advance that it is coming to inspect. That is not the way inspections are done in the U.S. Here, inspectors show up unannounced so the company has no time to clean up its act. Some readers, like this one, wonder how they can tell where their generic medicines came from.
Q. How does a person know if a drug they are taking is produced in a foreign country, diluted or even filled with harmful chemicals?
A. Your questions are challenging. Although food and clothing are labeled with country of origin, medications are not. We find this bizarre. If you can tell at a glance where your shoes or sweater were made, why not your medicine?
Your Pharmacist Has Vital Information:
You will need to ask the pharmacist which company made your pills. Sometimes it can be found on the label of the prescription bottle, but it is often in very small print. Before you take your bag of medicine out of the store, ask the pharmacist:
- What company made my pills?
- What country did they come from?
In the event that your pharmacist does not know where the company is located or where the pills were actually manufactured you may need to look the company up online.
Do not rely on the name to provide clues as to country of origin. For example, some people might think Wockhardt is a German company. In reality it is an Indian pharmaceutical manufacturer. The FDA has on occasion accused Wockhardt of deleting data and hiding results from tests. Some of Wockhardt’s manufacturing plants have been banned from exporting medications to the U.S. market.
Testing is Challenging:
As for contamination, you have to trust your pharmacy to supply quality medicines. If you suspect a problem, report it to the prescriber, pharmacist and to FDA’s MedWatch.
Unfortunately, the FDA does not seem enthusiastic about receiving pills from consumers so they can be tested. Even when people send the FDA medications that they think posed a problem, it is unlikely that the agency will test them or report back to the patient (or health professional) what they find.
Many Links in the Chain:
The manufacturing of generic medicines has a surprising number of links in the chain. Each link poses a potential problem.
- The API (active pharmaceutical ingredient) is the actual medicine. It might be made in China or Thailand.
- The “inactive” ingredients (binders, fillers and coloring agents) might be made in Bangladesh or Slovakia.
- The final dosage form of the pills could be formulated in India.
- The shipping of medicines from abroad to the U.S. is a mystery to us. We’ll bet your pharmacist doesn’t know either. Can some foreign generic pharmaceutical companies afford to ship by air or do they rely on container ships? Are the pills stored under careful temperature and humidity-controlled conditions? Does the FDA monitor transportation of medicines from foreign manufacturers to U.S. distributors?
- How are pills shipped from ports of entry to wholesalers and mail order pharmacies? Do mail order pharmacies ship under temperature and humidity-controlled conditions?
It seems to us as if there are a great many opportunities for problems all along the chain of manufacture and distribution of generic medicines.
Stories from Readers:
Naomi in Maryland is in a bad bind:
“I was in a car accident that caused a brain bleed. That resulted in a hemorrhagic stroke. I had to relearn how to walk and talk again.
“As a result of brain damage from my stroke I have seizures. It is very important that I take medicine that works. I’ve gone through several generics and NONE worked for me. I took generic Keppra, I broke out in a rash, then my neurologist played around with the dosage of oxcarbazepine generic (Trileptal).
“While on oxcarbazepine I broke out in sores on my forehead that won’t heal. I had two break-through seizures while I was taking generic oxcarbazepine.
“Now my neurologist writes on the prescription (DAW) dispense as written. It now costs me $188 for brand Trileptal and $261 for brand Topamax. That is the price for the American way if you want to stay alive.”
M.J. also had problems:
“I have been on the name brand of Cymbalta for 5 years now. Suddenly, my insurance company has decided that because there is a generic for Cymbalta (duloxetine) that I now have to take it instead.
“I have tried 4 different kinds from different manufacturing companies, and NONE have worked. Only the BRAND name Cymbalta works on me!
“I have spent months fighting with my insurance company. My wonderful doctor constantly wrote on the Rx: “Brand Name Medically Necessary.” My insurance company still will not pay for my Cymbalta! I have even had blood work done while on each generic, proving that it wasn’t working or even showing in my system!”
Sheila in PA shared this report. We have found that chronic pain patients can tell quite quickly if their medication is not working:
“I recently got my first refill of 10 mg Percocet manufactured by an Indian drug company and am so angry. These are the worst pills I have ever taken and they do not work!
“I have had my Percocet from several different manufacturers and none of those have ever come close to being as bad as the ones from this company. Not only do the new ones not work, but they make me feel absolutely awful. That is in addition to all the pain you are already in.
“What in the world is the FDA doing? Certainly not their job!
“Now, I ask the pharmacist what company they are using before I fill my meds and go elsewhere if necessary. FDA, you are doing the consumer more harm than good!”