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Are generic drugs equal to brand name products?As a new feature of CNNhealth.com, our team of expert doctors will answer readers' questions. Here's a question for Dr. Gupta. From Don, New Berlin, New York “I am curious to know the differences between generic and name-brand drugs. What makes the prices so different? Is there a difference in quality?” Answer Hey Don! As you accurately observed, the main difference between generics and brand-name drugs is the cost. Generics cost less than a third as much as their brand-name counterparts. Why the price difference? Because makers of brand-name drugs want to "brand" their identity - and the way to do that is through advertising. These companies pay large amounts of money to catch your attention, and that money factors into the cost you pay. As far as how they compare in quality, here's the scoop: The active ingredients - the things that make the brand-name drug work in the first place - are also found in the generic version. What might be different are the generic drug's inactive ingredients - things that might affect how quickly a drug is released, the size and shape of the pill - there could be variation there. There has been some anecdotal evidence suggesting some types of drugs may react significantly differently between the generic and brand. However, according to the FDA, they all undergo and meet the same strict regulations for safety and efficacy. Still, some docs may not want to risk even the small chance that a generic will react differently from the brand, so you need to have that conversation with your doctor to figure out what’s best for you. If you do switch to a generic and notice you’re reacting differently, there are things you can do. You can try a different generic; there are often several versions of the same generic drug, like a two-tablet version of the same medication, instead of one. You can also have your doctor write "Dispense as Written" or "Do Not Substitute" on your prescription so that you can stay on the brand name, but you may end up paying more. But remember, with most generics, you’re probably not going to see any difference at all, except you might find a bit more cash in your wallet.
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love. Recent Comments
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I was on a brand name drug for over a year with no problems and the drug went to a generic version and slowly over three months my symptoms came back. I have since gone back on the brand name – paying 7 times as much for one month and have seen tremendous results. I am starting to feel back to the way I was before the generic drugs but am not sure how I am going to pay for the medicine. I am having talks with my insurance and will see if there are any other types of the same drug but not in generic form. Most people didn't/don't believe me when I say that the generic wasn't working, but I know that it wasn't...I'm the one using it! I am mad that insurance companies won't cover brand name medicines when a generic becomes available...especially if you try the generic for a few months and don't get results...the insurance companies are controlling our quality of life! How can someone who pays say $50 a month for medicine now come up with $400 a month? That is more than a car payment! I realize there is no amount of money that you wouldn't want to spend to feel healthy, but how do you come up with that kind of money every month? I would definitely recommend to anyone on generic and not having the same results to talk to their doctors. My doctors did switch me to a different brand name drug and I am going to try it and see what the results are.
Bravo Dr. Gupta,
I am exposed to this same question and processes on a daily basis.
The public DOES want to know why the cost difference of generic v. brand/trade name. You have touched the most key point of active and inactive ingredients.
The fact that the average Pharmaceutical manufacturer, in 2007 and probably more in 2008, spent approx. $850Million dollars in bringing their "wonder" drug from research to market. This drug is granted 20 years to recoup their expense. The Generic manufacturer files an application with the FDA to manufacture their generic version after loss of these patents, at a greatly reduce expense. We still need the inspiration of the originator to be rewarded, if possible.
Allergic reactions are another main topic on substitution. We should VALUED Both sides of the marketing of our medications.
Sincerely,
J.A. Tinervia CPhT, MBA
Pharm Tech Faculty
I take a number of generic with good response, the name brand are specified but I appreciate hearing Dr. Gupta's remarks.
You should always check with your pharmacist first. If you are prescribed a controlled release drug, you might not want to take the immediate release generic brand. Not only do you have to take the drug more often, the side effects can be more severe.
Just would like to clarify... brand name drugs cost a lot more than generics because it costs about a billion dollars and 10 years to discover and develop them. Marketing the brand does cost money, yes, but a fraction of what it takes to develop a drug and run clinical trials to make sure they're safe and effective. Once the patent is expired, a generic company doesn't have to do any of the legwork. It's all been done for them. No wonder they can sell them so cheaply.
As a physician and former research fellow at the NIH, I have found that there are even differences between the same active ingredients. The proprietary synthesis and crystallization of the active ingredient is different for the brand name drug versus the generic. Whether that difference translates into real clinical differences in efficacy or side effect profile may not be known, but the studies that originally validated the drug in the first place are based upon the brand.
Crystals are not absorbed: Before the drug is absorbed it is dissolved in-vivo, and once dissolved, crystal history is gone. Before a generic drug is approved by the FDA for sale, it must be shown to be absorbed into the body at an equivalent rate and extent as the brand name drug.in a cross-over clinical trial to show this equivalence.
As a pharmacist, Joseph does a great job summarizing the issues facing big companies. He mentioned that it cost drug companies about "$850Million dollars in bringing their “wonder” drug from research to market," but what is not seen is that it takes about 200 new drugs to go to trial before one usually makes it to market. Companies must offset the expense of drugs that go to testing but fail to make it to market. Another issue that he mentions is that the patent is only given for 20 years, but that change is recent. Until recently, drug patents were only given for 17 years from the date of drug application which gave companies even less time to reap the benefits. "The recent change aligns U.S. law with the provisions of the Uruguay Round Agreements under the General Agreement of Tariffs and Trade (GATT)." The financial situations that these drug companies is a tough one.
Hi Don:
I believe that most meds you can do the generic. But I was told by two doctors, that when it comes to thyroid medication, you should take the brand name, because there is a slight difference in strength. I also wanted to ask Dr. Gupta if he can recommend a very good Thyroidologist, or a Endocrinologist for me. I would really appreciate it if he could. This is for someone who lives in New York City, but would be willing to travel, if he knows someone who is great.
Thank you,
Marcia
If, as Dr Gupta says, the so-called inactive ingredients that can alter how a drug is released ... seems like they aren't so inactive then, especially in an extended release form.
Like Ireland, I had no problems with my name-brand drug (for blood pressure) but, had alternating bp spikes and light-headedness on the generic which is the only thing my government insurance now covers so, I pay for my own name-brand. (Additionally, there has been a recall of the generic and still the government insurance won't cover the name-brand!)
Unlike Ireland, I won't accuse the insurance companies, at least not totally. Probably many of the decisions are set simply by one's employer when the decision is made by the type of healthy insurance policy purchased. In my case, the federal government decides what they want the military/retired military insurance program to cover; the federal government through their formulary committees are setting the rules, parameters of what the drug coverage will be and makes certain generics mandatory. And, for everyone, the federal government makes the laws that allow insurance companies to mandate generics and the federal government through the FDA makes the decisions as to what generics are supposedly equal to name-brand.
The FDA does not rerquire safety testing for generic drugs. Essentially equivalent bioavailability/pharmacokinetics is all that is required for a generic to be marketed.
I have been taking synthroid since 1970. I had my thyroid removed at the age of 13. I have always taken the brand name. My mail order pharmacutical company sent me the generic one time. I gained 12 pounds! I make sure my physician specifies brand name necessary on my RX.
Generic drugs are all different. I was on several generic drugs for thyroid problem. Every time I recieved the drug my thyroid went bonkers. I was on several different doses depending on the manufacturer. I finally got tired of my heart pounding one month, being exhaused the next month etc and switched to the name brand, In the long run it saved me from going to the Dr for blood tests every month to get my dosage adjusted. This saved the insurance company too. So Generics are not all created equal and every manufacturer has his own formula. In addition these companies do not have to test their drug for strength etc. They can be manufactuered by someone in a small operation such as was shown on a TV program. The owner made 8 different drugs and never tested any of them. He does not have to since the goverment does not require it. It is a bad joke on the citizens of this country. And I thought we lived in a civilized well protected environment. That is a joke when it comes to drugs. We are at the mercy of the insurance company and all they want to do is watch their bottom line so if you are sick you very well may have to pay for your drugs out of pocket.
I have a problem with another generic and am willing to pay the co pay and the cost difference between the name and the generic which is very small $30. They will not let me do that. If I want the name brand I have to pay the full price without insurance. Where is the governemnt?
I am told that the permissible variation in the amount of active drug in a generic pill is much higher than in the name-brand pill. This together with the effect of different inactive ingredients will influence how the medication is absorbed, particularly so, in the case of extended release medication. This I have found it to be true from my personal experience.
There are a few comments listed here from patient's with thyroid conditions. While the FDA does have standards for generic drugs being equivalent to the branded version of the medication, the FDA actually allows up to a 20% (some cases have been as high as 33%) variation in the amount of active ingredient in the medication.
For most medications this has little if any real clinical effect. For example if you are supposed to be on 25 mg. of a bloodpressure medication the generic may have as little as 20 mg. or as high as 30 mg, however since the next dose is 50 mg. there is little clinical difference between the generic and branded versions of said medication.
With Synthroid or Levoxyl (levothyroxine is the generic) the dosing is so small and narrow that the above example does not always hold in the clinical setting. For example, if a patient is supposed to be on 125 mcg. of Synthroid (20% is 25 mcg.) you could be receiving as little as 100 mcg. or as high as 150 mcg. These medications can be dosed at 100 mcg, 112 mcg, 125 mcg, 137 mcg, and 150 mcg. As you can see, the 20% variation allowed by the FDA for generic manufactures encompasses 5 entire doses of thyroid hormone and a different amount of medication allowed may not be the correct dose for a patient.
Lastly since generic medicine is considered equivalent a pharmacy may change manufacturers for their levothyroxine (the generic) without notifying the patient, even though the dose of medication may not be right for them. Here is a statement on the subject from AACE (American Association of Clinical Endocrinologists).
http://www.aace.com/pub/pdf/guidelines/AACE-TES-ATA-ThyroxineProducts.pdf
hello Doctor,
hello Doctor,
I was just diagnosed with low thyroid. I start medication two days ago. The doctor prescribed me levaxol, but the pharmacist gave me the generic band, levotyroxine. It is the same? I'm a little concern because I read that when is a thyroid medication, you should get the brand one.
Thank you
Erminia
I find this interesting given that my 11 year old son takes multiple seizure medicaitons all in the generic form. Recently, we were dispensed a different generic form of one and since then, he has been extremely sedated and drooling like a faucet. with his neurological damage, a little drooling is typical for him, but the excessive amount is not usual and can be quite dangerous form him. If he doesn't drool, he sounds like he is drowning in his saliva putting him at risk of aspirating. We cut the dose back today and I can already see a difference. It is another example showing that we need the same FDA regulations on generic drugs and monitoring.
For the most part, as a pharmacist I highly recommend generics. Certain medications, primarily those that require titration and tight dosage controls, are the exception.
Digoxin, Phenytoin, and Thyroid Replacements are some examples. There are quality generics for these products, and so long as a paitent is stable on one generic (or the original trade name drug), my recommendation is to not change to a different manufacturer if possible.
Unfortunately, generic manufacturers do not all have reliable supply chains, and many pharmacies are compelled to stock different manufacturer's versions of the same drug.
For this reason, I suggest to anyone on one of these medications to use the original branded product if they can afford it.
As much as pharmacists, insurance companies and some Drs. want to believe generic are not different than brand, I am the patient and my Dr. and I saw the devastation of generic anti-depressants. Some are ok, but many are not, and yes, it's the inactive ingredients that make it so dangerous. It's like going off of them immediately, which is NEVER recommended. People are crashing and burning and nothing is being done about it. Suicides have happened, but they'll never be able to prove it. My Dr. files an FDA complaint with every patient, along with myself, but, to no avail.
Bottom line it should be up to the doctor and patient,not an insurance company,mediciad etc.If the doctor writes brand name it should be mandatory that the patient gets it.
I had my thyroid removed in 1991. My doctor and I agree that name brand Synthroid is the medication I should take. I tried the generic form with very poor results. With my insurance, the cost for the name brand medication is actually cheaper than the generic. If you have insurance check to ensure that the generic medications always cost less.
What really gets my goat is these new drugs where they put two generics together and then charge an arm and a leg for it! I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this! The unthinking public is going to pressure their doctors into giving them something just because it’s new, when something old or generic would do the job for cheaper.
Generic and Brand can be hugely different for the sensitive population...
It is bothersome when the expert doctors and others start sounding like parrots – regurgitating the same OLD information, touting the lax FDA studies and being shills for the insurance companies who have everything to gain by forcing use of generics as a form of long awaited cost control. Cost control that ends up costing consumers and insurance more on the medical benefits end when the generic ends up to be a complete failure on the unsuspecting patients. Patients, who, for some reason, trust the experts, doctors and insurance to do the right thing. The right thing has not and probably will not be done with regard the brand medication versus generic. Congrats on being a bunch of lemmings and believing what is spoon fed to you by the media.
I have been using generics for a long time more than 3 years. I find it good only since the active ingredients are same in both brand and generics. I have been getting quality generics from good manufacturers at International Drug Mart. I feel comfortable and healthy too on having generics.
With the current news concerning control of generic and veterinary drugs, what is your view of Missouri's removal of Pharmacy Board oversight of prescription medication such as propofol, if the medications are sold for use in animals by third party outlets not having a pharmacist? Currently the pharmacy board has not right to oversee any company selling these drugs and cannot enter these to review dispensing to the public. This does not pertain to Veterinary Pharmacy within an animal clinic as the veterinarian is licensed to prescribe and dispense these drugs. But these are retail outlets that employ high school students and otherwise untrained employees to dispense prescription medication.
My husband is a pharmacist for CVS. CVS pushes the generics, and also makes the pharmacists push them.
I have a MCTD and have to take several medications. I am sensitive to drugs and not only can tell the difference between a brand name and the generic, I can tell when CVS buys a generic from another company.
We get no discount for the brand name, but I need what works.
What is so frustrating is that most doctors and pharmacists do not believe there is a difference between the brand name and a generic, and sometimes the differences are unbearable.
I was put on Effexor XR anti depressent drug was doing fine until the Druggest put me on generic venlafaxine75 mg I now am back to crying I am sad and I have fibroymagalic for 16 years . do you think it is because the gereric is not doing the same as the name brand?
A number of patients with a history of good results on brand name antibiotics began experiencing difficulties when a generic was substituted. Therefore, if you have prescribed a brand name tetracycline for a patient using antibiotic therapy and have not specified d.a.w. or no substitutions, your patient is probably taking a generic version and may be having a less than significant response to the treatment. Some generic versions have been found to be ineffective for this treatment.
Does every brand- name drug have a generic counterpart?
How long does a drug have to be on the market before generic drug makers can copy or manufacture it ?
James,
The short answer is that when a Pharmaceutical Mfrgr requests approval of the FDA for a new Medication, they submit a New Drug Application or NDA. This NDA upon approval is given a 20 year "protection" patent that allows the manufacturer a "window" of opportunity to 1st prove to the FDA that the drug will "clinically proven" (with 3 levels of testing) that the medication will therapeutically perform as specified over a clincal trials testing (3). They must prove through these clinical tests that the medication is proven to be "safe and effective" on the listed disease/disorder therapies. They have 20 years to prove to the FDA this safe & effectiveness, then be allowed to market the medication for the proven therapies. This drug research to market averaged $850M per drug in 2009 so the manufacturer does warrant the protection by the FDA. After, proven the manufacturer can market the medication for the balance of the 20 year period under protection of the patent protection. The generic pharmaceutical manufacturers then have the "free reign" to copy the original brand/trade name with the Abbreviated New Drug Application ANDA. Their Generic must be Therapeutically Equiv. to be allowed to market the generic to the public. This is a brief explanation James, so you can see it tends to be lengthy and involved by all parties. We are talking Billion and billions of dollars though so many are involved. I'm sure i've run out of room....
Kaycee,
No, only the brand/ trade name medications that have lost their patent protection can be substituted by a quality "generic" drug that has been approved by the FDA for market. The above comments give you a brief explanation of the approval process. It is based on the manufacturer's application (ANDA) to the FDA that the medication is "safe and effective" for the prescribed disease or disorder's therapy. Also, that the medication is therapeutically equivalent (AB1, AB2, AB3, ...BX) rated for prescription applications. So, if there is no approved generic medication for your brand name or trade name drug, it is because the manufacturer is still being protected by their patent. Which They Do warrant the approved time to recoup their $$$ vast expenses in bringing the drug from research to market. We Need to Keep theses guardians in place...or they will fade into reality.
Thanks
Hi everyone. My psychiatrist told me I am very sensitive to drugs. I cant understand this. I am on wonderful medication that is really helping me. I am on 50mg Ritalin and 75mg Effexor. However ay new drug I get given knocks me and when I sometimes take my last dose of Ritalin my eyes start vibrating,all my muscles go tight and my eyes vibrate. This seems so unfair. Does this mean my body will eventually reject all meds. Please tell me this is not so. I am so happy on my medication. Thank you
if it works for you then dont listen to the doctor because they dont know what works and what doesnt only you do.
Joe Tinervia: Should the companies be repaid at an exorbitant rate while their patent holds, at the expense and hardship of the patients, or should they be repaid at a much reduced rate over a much longer time scale?
To Camille
I am a pharmacist.... Just wanted to put that out there. About your concern with active ingredients and in-active ingredients. Active ingredient is the term used to describe which part of the drug product has the desired effect. For instance, you have high blood pressure. So, you take your amlodipine (generic for Norvasc(R)) tablets. The amlodipine is the active ingredient because it will perform the desired effect of lowering your blood pressure. The other components, diluents etc.. are called "in-active" because they do not alter your blood pressure. They serve as a vehicle to deliver the active ingredient into your body and later blood stream. The term "in-active" is not used to mean there is no activity what-so-ever from the "in-active" ingredients, but merely that you are not taking amlodipine for the sugar coating.
Dr. Gupta – Regarding generic drugs, I have been prescribed a generic Levothyroxin (because of a slightly below range T-4), which was obtained through my health insurance pharmacy. January 1 my company changed to a different insurance provider and the Levothyroxin through the new pharmacy was from a different producer. My most recent blood work (3/10), which is done every 3 months, showed a high level of T4 Direct Thyroxine – 2.47. The two generic meds were identical – 125mcg – as was the dosage. This seems to be an extreme variation of action of a generic drug from two different manufacturers – doesn't this suggest a conflict in accuracy and efficacy of prescribed generic medications? Isn't this problematic?
I recently switched to brand name metropolol after years of uncontrolled hypertension and use of generic medication. For the first time my blood pressure is within normal range. Unfortunately, the damage to my heart has already occurred. I have no idea whether the loss of my pituitary gland plays a role in the lack of efficacy of generic drugs, but in two instances switching to the branded drug has produced noticeable improvements in my symptoms.
There are many things a physician must review with their patients before suggesting a generic equivalents. I will always wonder whether using the branded drug would have prevented my cardiomyopathy and diastolic dysfunction.
Cost of prescribing brand name drugs is not an issue when compared with the cost of hospitalizations for heart failure, a life of disability, and premature death.
Here is the link to an FDA drug development document: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf
Specifically page vi, the first full paragragh describes how the FDA tests to assess for equal drug amounts between generic and brand.
The generic is tested against the brand. Any results outside 20% of the brand name drug dose is deemed unacceptable.
This means that anything within 20% of the brand dose is acceptable.
Therefore, if the brand name drug dose is 100mg, expect the generic dose to be anywhere between 80 mg and 120 mg.
Generally, this isn't a problem for many people. Which is why generics work for many people. It becomes a problem when someone who must have 100 mg and is now getting 80mg.
So, Dr. Gupta, it is ignorance or falsehood to state that the generic's active ingredient doses are equivalent to the brand when the FDA themselves have deemed that generic's active ingredient can vary by 20% in either direction of the brand's active ingredient. .
When one lot of a brand name drug is compared to a different lot of the same drug by the same manufacturer, by the same bioequivalence test used for FDA generic approval, one very often finds the same variations between lots as there is between two different manufacturers. Very carefully controlled dosage administration by IV has shown that it takes more than 20% or more variation in dosage to see a different response to insulin, hence a 20% difference in bioequivalence testing.is deemed acceptable.
My question: Is there a place where I can have a pill tested to evaluate whether it contains the correct dosage/ingredients?
I was recently switched to a generic thyroid med by my pharmacy and immediately had a health crisis. After 5 days of taking the medication and 2 trips to the emergency room (with spiking blood pressure and uncontrollable nosebleeds) I made the connection between starting a new bottle of pills and getting sick – so I stopped taking it. Within a few days I was back to normal. I really want to find out if I got a bad batch or had a reaction to an individual ingredient in the generic. I NEVER want to go through that again! So – is there anywhere that a private citizen can go to have a drug tested? Thank you.
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We have a nursing research our topic is ANALYSIS OF GENERIC AND BRANDED DRUGS AS PERCEIVED BY THE PHYSICIANS. To Dr.Gupta, what are the factors affecting your perception about generic and branded drugs? and can you suggest for tool that can we use for gathering datas?
Thank You and God Bless You
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Like Martha Jeanne, I also would like to know if therre is any place to have a pill tested for the active and inactive ingredients it contains. I have recently switched to generic medication and I do not believe it has the same ingredients found in the brand name. I have looked up labs and they seem to only test blood & urine. Thank you!
I would like to read more on that site soon. BTW, pretty nice design your site has, but how about changing it once in a few months?
generic medicine's are not even close to being as good as brand name! i should know ive been taking them for 6 years now! generic works in only half the time for mr spinal stenosis and missing (all)disc.
i wanted to ask Dr. Gupta if he can recommend a very good drug for the chemotherapy of my uncle having lung cancer because we are confused to decide which medicine is best....branded or generic?thanks
The debate "Brands versus Generics" has been continued on for years. Will there be a definite answer?
It would require the generic manufacturer to conduct well controlled studies to clearly prove their generic medications are as effective as the "brand name". But the main reason generics cost much less than brand name drugs is that their manufacturers don’t face the same development costs as brand-name companies. The process of research, development, and particularly marketing requires millions of dollars!
As Dr. Gupta mentioned – most generics work quite well and allow to save money. But not always!
This article gives explanation regarding differences between brand and generic drugs:
http://www.originaldrugs.com/blog/general/brand-vs-generic-drugs/
I had a kidney transplant 8 years ago. I take many medications, which have to be taken for life. About a year or year and a half ago, some of the very expensive meds were changed to genetic, like Celcept and Prograf. Since I started taking the genetic names, every few weeks, I get headaches, nausea and diarrhea, no vomiting. I feel it cannot be a virus because of the frequency of the symptoms. Could it be due to the change from brand to generics? I did not have the symptoms when I used to take the brand names. I used to take Medrol (brand name) it was changed to genetics, about the same time, as the others and it was discontinued and back to Medrol. I really appreciate your help in this matter. Sick of getting sick.
Myra.