safety concerns

Over the last several years a large number of Indian generic drug manufacturers have been sanctioned by the U.S. Food and Drug Administration. In many cases factories have been banned from exporting their products to U.S. pharmacies. Although the FDA rarely shares the names of the products involved, we have heard from a great many people that beta blocker heart drugs in general, and generic metoprolol in particular, pose problems.

Q. I read in your column about a drug recall of metoprolol succinate made in India in 2015. The first time I ever took a tablet of generic metoprolol succinate, I landed in the hospital. The bill for that one day was $26,000. I am certainly paying more attention now to what my new doctor is prescribing!

A. We have heard from many readers of this column that some versions of the generic form of the heart medicine Toprol-XL (metoprolol) do not work as well as expected. One person wrote:

“I currently take a generic metoprolol made in India. I have been taking generics for years, but this latest batch seems bad! My blood pressure has been running 10 to 20 points higher than normal. Today it was even higher and my heart rate was faster. Doubling the dose didn’t help much.”

Heart Rate Reveals Problems with Beta Blockers:

Blood pressure that would normally be controlled but goes up on a generic beta blocker is a potential warning sign of trouble.

A faster heart rate is also a tip-off that a generic metoprolol is not what it should be. Beta blockers like atenolol, metoprolol and propranolol almost always slow the pulse. If heart rate goes up, there is a good chance that there is a problem with the medication.

Stories from Readers about Generic Metoprolol:

We have heard from many other visitors to this web site about problems with generic metoprolol formulations:

Corey in Florida shares this story:

“I took generic metoprolol and palpitations and chest pain continued and worsened. I called my pediatric cardiologist to find out what prescription i was taking as a teen because that medication worked well.

“I found out i was taking Toprol-XL. I recently started taking the Toprol-XL again and have had NO symptoms! The generic metoprolol was not a good fit! There is certainly a difference between the two.”

Kathleen has a similar story:

“I am so disgusted with generic drug compared to brand Toprol-XL. I have been switched by my cardiologist with the advice that ‘it’s all the same, you will be fine.’

“What a joke. Within 3 days I could not take a deep breath. My heart rate was fast, I suffered from PVC’s [pre-ventricular contractions], weakness and sky high blood pressure.

“I called my cardiologist’s office and they said it’s fine; just keep taking it. I said NO. I got brand name Toprol-XL and in days was feeling better. This is poison at best. We, the paying people, are getting a bad deal! Please beware people!”

Frances in California also experienced severe problems on generic metoprolol:

“I have been taking Toprol-XL for a long time but last year they gave me the generic because the brand name had gotten so expensive. Over the past several months I have experienced nausea, dizziness, diarrhea and my hair has been falling out.

“I just saw my doctor and we did a thyroid test because of hair loss and it came back normal. I also have been in remission for cancer and went to see my oncologist and am still in remission. Since the only med I take is for blood pressure he said it had to be the metoprolol.

“My blood pressure has increased to 170/100 since taking the generic. Why don’t doctors keep better informed? The pharmacist told me the generics aren’t made with the same FDA guidelines and many are made out of the country. I will be switching back as soon as I can get ahold of my primary care physician.”

These are just a few of the very many reports on our website. To read more comments about generic metoprolol, go to these links:

New Report Compares Toprol XL to Generic

Metoprolol Mess (Toprol XL) Reveals Serious Flaws With FDA’s Generic Process

New and Serious Problems from India:

In the last few years, the FDA has scolded dozens of the largest generic manufacturers in India for data manipulation or faulty quality control during manufacturing. In just the last few weeks there have been additional reports of problems:

FDA Slams Indian Drug Companies:

An Indian company called Semler Research, that tests medications in patients, received a letter from the FDA on April 20, 2016. It stated in part that manufacturers that relied on Semler’s data to submit applications for generic drug approval should know that studies “are not acceptable as a result of data integrity concerns, and need to be repeated.” The FDA noted its “inspection found significant instances of misconduct and violations of federal regulations, including substitution and manipulation of study subject samples.”

A letter was sent to Ipca Labs stating that there were a variety of “deviations from current good manufacturing practice…” It went on to state:

“These practices appear to be commonplace in your analytical laboratory. During the inspection, our investigators spoke with an analyst who reported that ‘…if we find a failure, we set back the date/time setting and re-integrate to achieve passing results…’ The analyst explained that deleting, overwriting, changing integration parameters, and altering PC date and time settings were done for raw materials, in-process testing, and finished API [active pharmaceutical ingredient] drugs.”

In a March 3, 2016 letter to Emcure Pharmaceuticals the FDA told CEO Satish Mehta that:

“We identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals…Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity…During our inspection, we observed multiple examples of incomplete, inaccurate, or falsified laboratory records.”

These notifications are just the tip of the iceberg. Over 40 Indian drug makers have had products banned because of serious violations. Sadly, the agency rarely tells American health professionals or the public at large which drugs are involved in these violations. As a result we cannot tell you which generic metoprolol products to avoid.

Is it any wonder that many consumers have lost confidence in generic drugs manufactured abroad? If you want to learn more about the generic drug scandal in America and why Kathleen’s cardiologist was off base when he told her “‘it’s all the same, you will be fine…just keep taking it,” check out our book, Top Screwups Doctors Make and How to Avoid Them. We have a whole chapter devoted to “Generic Drug Screwups.”

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  1. Nimmie Sehgal
    Cincinnati,Ohio
    Reply

    I only use BRAND NAME medications from India and & have not had any problems.
    We use Diovan Hct ,Crestor, & branded Topro XL but I will be leary
    about Generics from India.

  2. Anthea
    Illinois
    Reply

    Just want you to know that I greatly appreciate the information that you make available.

  3. Barbara C.
    Florida
    Reply

    Regarding the question of generic Toprol XL being dangerous, I would like to report that my husband began that drug, but we later asked his doctor to switch to the non-extended release version, Metoprolol Tartrate, to save money –down from $90+ to $6 for a three-month supply. Quite a savings. The only difference was that he takes a tablet twice a day instead of once as with the timed-release (XL) version. Both he and my 50-year-old son take the old-fashioned Tartrate and control their blood pressure very well with no side effects.

    The drug companies probably added the extended-release type after the patent expired on the Tartrate so they could milk more money out of patients. The manufacturer of the inexpensive tablet is Mylan–whether Indian or not I do not know, but a good chance it is.

  4. Thai
    Reply

    Your timely advice and information is such a great thing for your readers. Thank you! If you could list foreign companies that have come under scrutiny for producing bad drugs, it would be very helpful for us. I’m also wondering if the U.S. forbids foreign drug companies from selling to our insurance companies if they are found negligent in their production procedures or final product?

    If our government protected us in this way, it wouldn’t be necessary for patient consumers to check every prescription bottle for foreign company names! Thanks if you can publish such a list, as it is hard to tell from the company name alone if it is foreign, or not.

  5. Frank
    Dallas
    Reply

    I tell my pharmacy I don’t want any Indian made generics. With a little research you can find the US manufacturers and request one of those.

    You can also as has been mentioned on this site before, with a little more research you can determine if there is an authorized generic and request that. Of course not all meds have an authorized generic, but many do. Prices are about the same as the non-authorized generics. Sometimes you have to call a couple of pharmacies to find it once you determine there is an authorized version.

  6. Elizabeth
    The Villages, FL
    Reply

    I had a big problem with a generic from India – the product had a very bad odor. The pharmacy had the co. call me and I sent part of the product back to them. I have not heard back yet. Can I Please print the article re” generics from India?

    • Terry Graedon
      Reply

      Elizabeth, of course you can print the article. We hope it helps you sort out this problem.

  7. Dr Patrick Neustatter
    Zimbabwe (at present)
    Reply

    I am a physician visiting a friend in Zimbabwe who is pretty sick with myeloma and needing a lot of medicines. But the economy here is in a shambles and people can’t afford the care they need very often – in particular high priced medicines. Our friend is liable to die just from running out of money.

    So the other side of your knocking generics as being unreliable is the outrageous behavior of both name brand and generic drug manufacturers in jacking up prices, way beyond what a lot of Americans can afford – let alone the third world.

    I agree that a better vetting system by the FDA, and improved manufacturing standards would be the ideal solution. But the Indian generic drug manufacturers do help a lot of people in other countries afford medicines they otherwise couldn’t.

    • Terry Graedon
      Reply

      We agree that there is a role for good quality generic drugs, in the US as well as in Africa. Sadly, some pharmaceutical companies don’t figure they need to do quality control on drugs destined for Africa, since most of the countries do not have any way of monitoring.

  8. Phil
    California
    Reply

    The better question to ask might be “can you trust ANY medication coming out of India?” I have read of so many problems with their “drugs” recently, plus saw a “20/20” type program on TV about 6 months ago where some drugs are manufactured by individuals with no medical background at all. They are given a “formula” and then buy their components from local “manufacturers”, and then by hand were opening capsules and putting the ingredients into each one by HAND! Great job FDA!

  9. Dave
    Williamsburg, Va
    Reply

    If generic drugs from India are highly suspect, how do I check to see if the drug I am ordering via Canada from India has had any approval ?

  10. Drew
    Richmond, VA
    Reply

    Thanks for keeping up the news regarding inferior Indian-made generic drugs. I’m 60 and only take OTC Prevacid now. I should be taking a statin and Flomax generic. I tried two generics, and they hit me all at once and then stopped taking them. My understanding is the fillers used by “those” manufacturers are part of the problem along with other quality issues.

  11. Bill
    Canton
    Reply

    Regarding junk medicines coming from India: I am epileptic and am on Valium. I always would ask for the Watson brand and would have no problems with seizures. I recently got a new script, and Miejers told me that they would not honor my request for the Watson brand and said the only thing they sell is TEVA from INDIA – I had siezures and Headaches! India could care less about the quality of their meds. My advice is before anyone gets a generic filled, research and make sure it is NOT MANUFACTURED IN INDIA

  12. Grace
    Reply

    I do not trust drugs from India, China, or Mexico. I have stated this before. I have worked with reputable pharmacists who have refused to fill Rx with generic drugs such as Lanoxin and Lasix. Most consumers do not understand just what generic drugs are. Could you explain what they are?

  13. Darlene
    Dallas, Tx
    Reply

    This is major information. But the info we are lacking, is how can we know where our generics are coming from.? Are there codes on the pills that tell or what help do we haven’t?

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