As we all know, an unaffordable drug is neither safe nor effective. No less true, an ineffective drug, whether dirt cheap or super expensive, can have hazardous health consequences, even death. That’s why consumers seeking low cost medication online look to avoid bad meds by finding accredited online pharmacies with a PharmacyChecker or VIPPS seal. But that might not always be good enough…
People don’t like to talk about it but sometimes switching from a brand name med to an “equivalent” generic can lead to serious health problems. And this happens at your local U.S. pharmacy, not just online. Tod Cooperman, MD, president of PharmacyChecker.com, knows about this more than most people. In his capacity as president of ConsumerLab.com, he participated on an expert panel at a Congressional briefing this past Wednesday, organized by a new group called the Safe Medicines Coalition led by economist and counterfeit drug expert Roger Bate, PhD. The panelists and others are authors of a new paper called “Drug Inequality: Allowable Variations and Illegal Underperformance in Off-Patent Drugs.”
Dr. Cooperman’s main contribution to the panel comes from his experience testing a generic version of the anti-depressant Wellbutrin XL. To make a long story short, in 2007 ConsumerLab.com tested Teva’s FDA approved generic of the 300 mg version called Budeprion XL – an extended-release product. A generic drug that is bioequivalent to the brand name drug is supposed to work pretty much the exact same way as the brand. Consumerlab.com found that Teva’s generic did not dissolve like Wellbutrin XL – it released the drug much too quickly. It took the FDA more than 5 years but it finally conceded that the product was not bioequivalent to the brand product because it released the active ingredient much faster.
According to the People’s Pharmacy, people taking this generic were feeling more depressed, and even suicidal – until they switched back to the brand or to a different generic. The People’s Pharmacy and ConsumerLab.com shared this information with the FDA back in 2007 only to be ignored.
In order for the FDA to approve a generic drug for sale in the U.S., it must be proven to be bioequivalent to the brand name drug –delivering approximately the same amount of drug over the same amount of time in a group of healthy volunteers. It turns out that Teva never did this for the 300 mg version of Budeprion XL. The FDA approved the drug anyway, based on the data and approval for a lower strength version, Budeprion XL 150mg. What’s more amazing is that generic medications, even though they are not the exact same as their brand name counterparts, under U.S. law, must have the exact same clinical data in their package inserts as the brand name drug. That is, the data shown in the insert is NOT actually the data for that generic. This is meant to give the impression that all generics are the same as the brand name product, even though that’s not the case. If that doesn’t seem to make sense then you’re thinking clearly.
In 2012, the FDA admitted ConsumerLab.com had been right, and stated that Budeprion XL 300mg is was not bioequivalent to Wellbutrin XL 300mg.
Dr. Harry Lever, a cardiologist, talked about patients who were not responding well when switched to certain generic heart medications, such as beta blockers. Most interestingly, problems not only occurred when patients switched from brand to generic but even from generic to generic, which takes us back to the efforts of ConsumerLab.com above and moves us into a new point: Not all generic drugs are equal to each other, and a particular generic might work better in one patient than another!
The key takeaway from Dr. Lever’s and Dr. Cooperman’s presentations is that if a certain generic drug is working for you, then try and stay on that exact same medication. You’ll find it’s not easy because pharmacies often interchange generic drugs in their dispensing practices. You can avoid this by making sure you ask for the same generic, meaning the same manufacturer, each time you visit the pharmacy.
Mr. Bate focused on the fact that drug quality, generally, is not equal from manufacturer to manufacturer, brand to generic, generic to generic, country to country, etc. Mr. Bate is not saying that most generic drugs don’t work but simply that they are not exactly the same. Dr. Preston Mason supported this by presenting data based on testing generic versions of Pfizer’s Lipitor. He found that different versions were not all equal. The lowest quality products, based on number of impurities, were made in India for export to poorer countries.
The final presenter was Dinesh Thakur, the whistleblower that outed major manufacturing problems and corruption at Indian drug manufacturer Ranbaxy. Ranbaxy was actually granted the first go at marketing generic Lipitor in the U.S., but their version was eventually recalled due to small particles of glass that may have contaminated the product. You might find FDA’s nuanced position on the recall instructive and of great interest: “Patients who have the recalled medicine can continue taking it unless directed otherwise by their physician or health care provider….To date, FDA hasn’t received any reports of injury….The possibility of adverse health problems related to the recalled atorvastatin is extremely low.” I don’t recall hearing that the drug was not effective either but its recall was precautionary.
So what the hell are average consumers and even their healthcare providers to make of all of this? I’m going to copy and paste from ConsumerLab.com:
- If a generic doesn’t work like the original drug, be concerned, particularly if it is an extended release (often called “XL”) product.
- Be aware that the labeling on a generic drug describing its performance is copied from the labeling of the original product and may not reflect the performance of the generic. This is a deception required by the FDA, perhaps to create the perception of generics as interchangeable.
- If a generic works for you, look carefully at the label and identify the manufacturer. Request the same manufacturer each time you refill that prescription. Other generics may not behave the same way.
From my perspective, despite the FDA debacle with generic Wellbutrin XL discussed above, the FDA is one of the best drug regulatory agencies in the world. Following the advice above, you can and should trust generic drugs sold in the United States. What about generic drugs sold over the Internet from foreign countries? Pharmaceuticals sold in the most highly regulated countries are generally equivalent in quality and efficacy to those sold in the United States. What about from Indian pharmacies? The highest quality medications sold in Indian pharmacies are on a par with those sold in the U.S., too, but there’s more deviation and far too little oversight from the Central Drugs Standards Controller Organization, India’s FDA.
For all of these reasons, if you’re buying online and getting a drug internationally stay away from websites that are not credentialed by PharmacyChecker.com. And remember, despite crazy price increases in a good number of generic drugs, most generic medications approved for sale in the U.S., sold at local pharmacies are less expensive than International online pharmacy prices – even cheaper than India! However, brand name products are usually far less expensive outside the U.S. (and apparently sometimes safer than generics) – and you can check those prices on www.PharmacyChecker.com.Consumerlab.com, Roger Bate, Safe Medicines Coalition, Tod Cooperman, VIPPS
Some generics in the US are outrageously over priced. Detrol LA is one. Pharmaceutical companies are a real rip off to the consumer.
I take diazepam to help me sleep, when needed. I do not take it on a regular basis. Usually a half of a 5mg pill works within minutes for me. My pharmacy recently switched manufacturers and the new manufacturer’s pills don’t seem to have any effect on me. I’ve even increased the dosage and they still didn’t work. Manufacturer is: FDB1. I feel like they equate to little more than sugar pills. I may have to switch to another pharmacy. Anyway, glad I found this blog. Thanks!
Dana you are exactly right ..my pharmacy recently switched to FDB1 too for my diazepam ..thank you cuz now i know it isnt just me ..thought i was going crazy cuz they do NOT work as the ones for yrs before have ..there have been numerous times i have felt like electricity & electrical charges going thru me since on them ..its scary & it sucks ! so afraid of having a seizure because these pills are not the right amount obviously 🙁 again thanks for posting Dana …now i know it is really them ..not me ! and i will be calling my pharmacy ..thanks & good luck to you too !
This is something I’ve said for years. I never understood how I could take a medication from one pharmacy, but not the next. I have now developed several drug allergies and after reading this article it could be attributed in part to this! It has made my life a living hell! What do you take for pain when you are allergic to almost every narcotic on the market? Tramadol. And then I have to be careful of the dye lots and the manufacturer! And to make it even better, my doctors look at me like I’m a drug seeker! I’m going to get high dollar for this Tramadal on the corner! Irritating. Didn’t mean to rant. This is only one medication it have several with the same outcome. It’s very frustrating!
I take glipizide er 5 pill. cvs was giving me a little orange pill. 2 months ago they changed to a larger pink pill and my sugar has never been normal since. they said that the company that made the orange pill is out of bus
ness. what should i do.
Hi Richard – I don’t give medical advice but in this case it’s very straightforward that you should contact your provider and make sure you’re getting a medication that works immediately.
Bewareof the manufacturers. After extensive research for my husbands medications when switched from one generic to another company, we have found that most generics made in India are not the same. Fillers are the cause. I researched online FDAForm 483s and was shocked at how many of these companies have been caught over and over using powder, cut glass, cyanide, rat poison, etc as fillers. You have to research extensively. I now have companies I will not accept any drug from. My husband has had good luck with Glipizide ER 5mg from Actavis. Good lujk. It is really a bad game for us consumers.
I was taken topomax from Walgreens and I had to change to cvs from there I have not been stable on my headaches and nervous. What can it be?
What can I do?
Hi Lily, It’s best that you consult your doctor regarding any changes in medication and change in side effects. We hope it gets sorted out soon.
Beware of generic drugs period. They are not the same in quality. Ambien ER works okay when needed but Zolpdiem ER has various manufacturers. I have tried several and none work and the one I found that was similar was taken away because of Insurance demands to purchase online. What a sad era we live in when we the patients are treated not as individuals but more like a community of robots!
What about Barrett’s esophagus medicine, the generic version of Nexium, do they all work the same?
The VA stop my Nexium and gave me the generic version of Nexium, so they say. Now my Barrett’s esophagus is acting up again and I’m getting pains like I used to again, after years getting it to heal…
Hi Tom–It’s best to consult your doctor regarding your reactions to generic vs. brand-name.
My husband had an accident in a gym in the year 2000. A cable snapped & 300 lbs. of weights hit his Head and his neck. He got a brain injury and Dystonia (which is a movement disorder).He also has seizures. He has been on the same medications for 15 years through Rite-Aid which is now owned by Walgreens. All his medications are from different manufactures. They are not working right for him. They are nothing like his old meds. He is having terrible side effects. He is confused, falls asleep during the day. He only sleeps 2 hours at night. He is hallucinating. He is normally very funny and sweet. He can be very mean at times. This is really hard. His doctor is in India for 2 weeks. I am trying to reach the doctors covering for her. I also talked to the pharmacy & they are trying to help. You know if your meds are working or not so don’t let any one tell you different. I am making dam sure he gets his old meds back. Good luck to everyone.
Is there an independent laboratory that confirms the configuration of the generic drugs? Even taking a drug from a reputable pharmacy I have found the quality changed from month to month even if the distributor (Mallinckrodt) did not. There seems to be no way to confirm the additives/amounts of actual ingredients…except by personal experiences or lack of effect. It is of no value to have a company “inspected” without quality controls being applied continuously. Of what value are complaints if FDA can’t verify?
Hi Carol –
As I believe this post clarifies, our position is that not all generic drugs are equal, but they usually are. The quality controls are the responsibility of the regulatory authority overseeing the relevant manufacturer. PharmacyChecker is not a regulator and we do not test medication. We can help assure patients that medicines, if ordered from PharmacyChecker-verified pharmacies, are lawfully-manufactured, safe and effective because they are dispensed from pharmacies that are regulated where they operate.
You raise an important point and concern: the same manufacturer making medicine inconsistently. I’m not sure what you mean by complaints. Complaints to who?
I had used some generic brand that I don’t remember many years ago of Metatropal for heart palpitations with no side effects,and last year my nurse practitioner prescribed it to help lower my recently diagnosed high blood pressure,and I felt sick as soon as I took it,and I took it for days hoping my body would get used to it and adjust to it,but it didn’t!
Then I asked for a different generic and I felt 100 times better, but it wasn’t lowering my blood pressure that much so the nurse practitioner prescribed 50mg of Losartan with 12.5 HCTZ, but this wasn’t lowering my blood pressure enough,and I tried 100 mg but it was too strong and upset my stomach and made feel sick,so I asked the nurse practitioner to prescribe 25 mg of Losartan without the diuretic, in addition and that only lowered it a little more.
And my pharmacy first had given me the generic brand Alembic for the 50 mg of Losartan,which was a softer different shaped pill,and I can’t swallow pills,and this pill doesn’t have a line that I can cut with my pill cutter, so I have to wet it with a drink and bite it into two pieces,and then my pharmacy switched to another brand, I don’t what it is because they just have the abbreviation of the name,but it’s a much harder pill so it’s harder to bite it, I have to wet it longer in my mouth,and the pharmacy says they can’t get the other brand anymore.
I had hardly slept at all in several months after being diagnosed with high blood pressure and the medications not lowering it enough, I was terrified that I was going to have a stroke or heart attack in my sleep. Finally the doctor who works in the same home MD practice came and met with me only once in February 2019 and he prescribed 25 mg of a beta blocker,Atenolol in addition to both Losartan medicines, and at first after taking it for a little while it reduced my blood pressure down to normal where it used to be not that long before when I had normal blood pressure without any medicine.
I had no bad side effects taking this,until my pharmacy switched to another generic which made me sick,so I asked them to please get the first brand and they did and they even told me this is the brand they usually get.
My blood pressure has gone up a little though since I had first started taking it.Just very recently after I had been taking the 25 mg of Losartan of the brand Aurobindo for 3 months which was a light green pill,they now switched generics to a white pill that made me feel sick as soon as I took it,but I took it several days alternating with the other brand that I had about 2 weeks worth left of,hoping my body would adjust to it,but this never happens.
So I called the pharmacy and told them about this and asked if they could please get the other brand back,and they said to call back in a few days after the pharmacist I spoke with said she would ask the woman who is in charge of ordering the medicines,and when I called days later she told me that they can’t get this brand anymore and suggested I call other pharmacies and see if they have it and they would transfer my prescription over to them.
So I called CVS who I used to go to for years and who are only about a walking block away,and they do carry this generic,so I had to call my nurse practitioner and get a new prescription since it was already recently filled for a 90 day supply.But my insurance company said it was too soon to refill it,and they did this for me before when I had a situation like this,so I called my nurse practitioner and asked her to please call my insurance company and explain the situation and get an override for the new prescription,but she actually refused and said it’s my responsibility to call,and that’s not really true,most of the time the insurance company needs to have the doctor call about this.
And this is even after the nurse practitioner had just been at my house days before checking my blood pressure,and she told me the same thing she told me before when I felt sick on the other generics,that she believes me because one of her patients was taking the same pain medication for years that was helping her with her pain,and then the pharmacy switched to a different generic and it did nothing for her pain.
And just days ago she said I should tell the pharmacists that they should make a note of what generic brands make me sick,and I said I already did this,and she said big pharmacies don’t really care about this,private pharmacies care more.I even had told her that CVS and my insurance company said they can’t fill the new prescription with the other generic until November 5,and this was October 1,so she actually expected me to take a generic medicine for a month and 5 days that was making me feel sick,and it’s a necessary medicine that I have to take to lower my blood pressure!
So I called CVS back and I asked them how much it would cost to pay for this prescription,and the woman I spoke to said a 90 day supply would cost a 100$ which I can’t afford,so she said do you want me to check a 30 day supply,so I said yes,she told me it would be 44$ so I asked isn’t there any discount? And she checked something with a card,and found me in their system from years ago,and said yes,there is and a month supply is 11.88 so I had to buy it out of my own pocket which is really wrong.
My nurse practitioner had called my insurance company many months before and said she was on the phone with them almost 3 hours to get the brand name of Benicar for blood pressure because my father has been taking it for 20 years and it really lowered his blood pressure,but unfortunately it caused my IBS to act up bad and I had to go back on the Losartan,this was before the doctor had prescribed the Atenolol in addition to the Losartan medicines.
I recently asked my pharmacy to get a different generic of Xanax because it was making me feel not well,and they did get a different brand but I only felt a little bit better, I never had a problem with other generics of it from different pharmacies in the past.Also I have IBS for 26 years now off and on with bad pain,which goes away for 4 or 5 months,but unfortunately comes back,and that’s the only symptom I ever got from it,well a GI doctor prescribed the only medicine that finally took my pain away, it was the Mylan brand of Bentyl which I took for years,and then when pharmacies switched generics I tried 3 others including a liquid and none of them took the pain away like the Mylan brand did,and I used to open up the little capsule and mix it in sugar free flavored water because I can’t swallow pills,( although recently I have been able to swallow the little capsule) and only the Mylan brand dissolved in the water.
But the Mylan brand has been on back order for the Bentyl for so long,first they told me in January of this year they were going to have it by February,then I call in February and they now claimed they were going to get it in September,so I forgot about them and luckily I tried a new brand that also really helps with the pain,and I really hope that my pharmacy continues to get it in,they said they usually get that brand.
Some pharmacists I have spoken with act as if they don’t know or understand that it’s a reality and fact that different inactive ingredients do have different side effects on many people,and or are not effective,but I had spoken to several pharmacists in the past who did say they know that certain fillers and inactive ingredients in different generics can do this.
It’s really wrong and terrible that pharmacies can and do do this to patients! I’m no longer seeing this nurse practitioner and I need a primary care doctor now.
How Differences Among Generics Might Effect Your Patient’s Response by psychiatry and pharmacy professor Vicki L Ellingrod University Of Michigan
Can different manufacturers of same generic drugs have different side effects?
Absolutely!! It’s difficult to find information confirming this, on line, but I can speak from personal experience in saying that with some medications I have noticed differences in efficacy and side effects when I have had to change to a different pharmacy that uses a different manufacturer for their generics.
How can the same prescription drug made by different manufacturers cause different side effects? – Quora
While the active ingredient remains the same, different manufacturers use different inactive ingredients as the binders and fillers. Different manufacturers may also use different colorings and coatings, all which could cause different side effect…
Does anyone have any suggestions on what I can do?
I have been taking generic ToprolXL 25 mg made by Teva for many years. My latest refill, I received Ingenus generic of ToprolXL. After about 10 days of taking it, I have noticed that I am feeling a little bit edgy compared to the Teva generic. Also have been feeling like my heart is racing at times. Could this be due to the change of manufacturer?