safety concerns

The Indian generic drug company Wockhardt is in trouble with the Food and Drug Administration…again. This makes the sixth warning letter the company has received. According to FiercePharma (an industry watchdog), seven Wockhardt drug making facilities have gotten into trouble with the FDA. Because of this, three can not ship medicines to the U.S.

Many Indian generic drug firms have gotten into trouble with the FDA over the last several years. They include:

Aurobindo
Cadila Healthcare
Canton Labs
Dr. Reddy’s Laboratories
Pan Pharmaceuticals
Polydrug
RPG Life Sciences
Ranbaxy
Sun Pharma
Wockhardt

Such companies have received FDA warnings about quality control or other violations of FDA procedures. Some have been banned from shipping products to the U.S.

Indian Generic Drug Company In the U.S.

We have been intrigued to discover that a number of Indian drug companies have set up shop in the U.S. Jubilant Life Sciences received warning letters from the FDA. A plant in Spokane, Washington had issues regarding cleaning and disinfecting processing areas and equipment. The most recent Wockhardt event involved a plant in Morton Grove, Illinois.

Wodkhardt’s U.S. company is named Morton Grove Pharmaceuticals. According to FiercePharma:

“The FDA has yet to make the letter public, but the plant received a Form 483 in 2014 that was issued after an FDA inspection that went on for 17 days. The plant was criticized for many of the same issues that the FDA had already found in its plants in India.”

Made in the USA?

Many people assume that if their medicine is made in the USA then it must be fine and dandy. That may not always be the case. It can take the FDA a long time to visit every manufacturing facility. There have been reports of serious violations in the U.S. as well as in India and China.

Can You Rely on Generic drugs?

We have been writing about generic drugs for over 40 years. For most of that time we were huge supporters of inexpensive generic medicines because we totally trusted the FDA to monitor quality. We took flak from brand name drug companies for our pro-generic stance. Here is just one example from August 17, 1987:

Q. Your pro-generic drug stance makes me sick. I work for a large drug company and I hate to see you preaching only one side of the story.

Generic drug manufacturers don’t put any money into developing new medicines. The sales of brand name drugs support research into new compounds. You should encourage your readers to stick with products from innovator companies so that they will continue to have better medications in the future.

A. Your argument would carry more weight if the big brand name manufacturers put a larger proportion of their profits into research and development (R&D). In recent years we have watched with horror as prices for prescription drugs have soared. Between July 1985 and April 1987, the overall inflation rate was under 3 percent while medicine jumped more than 12 percent.

Congressman Henry Waxman recently chaired a committee which investigated profits in the drug industry. According to Waxman, “the money was arriving in bucketloads, but was going to R&D in spoonfuls.”

Big brand name drug companies spend an extraordinary amount of money promoting their products to physicians–by some estimates, as much as $9,000 per doctor annually.

The pharmaceutical industry is one of the most profitable businesses in the world. Where does the money go? Last year, many of the leading companies paid their CEOs more than $1 million in salary and bonuses.

Many older people on fixed incomes can barely afford their medicine. Price increases on brand name drugs have been busting patients’ budgets. If generic drugs make medicine more affordable, we’re all for them. It isn’t fair to ask people on Medicare to subsidize free dinners for doctors and mega-salaries for executives, so we still think generic drugs provide quality at an affordable price.

Fast Forward to the Present:

That was 30 years ago. Since then the amount spent on advertising prescription drugs directly to consumers has skyrocketed. You cannot watch TV without seeing commercials for cancer drugs, psoriasis medicine or medications for rheumatoid arthritis. These are all extremely expensive products. CEOs now make a LOT more than a million dollars a year.

The New York Times  & Highest-Paid CEOs of 2016

Leonard Schleifer of Regeneron Pharmaceuticals was reported to pull down over $50 million in 2016.

Forbes said John Martin of Gliead scored $43.2 million, a real let down from his compensation in 2013, which was reported at $180 million.

Robert Hugin of Celgene “only” took in $22.5 million.

Alex Gorsky of Johnson & Johnson was reported to make $21.1 million while Kenneth Frazier of Merck received $19.9 mil.

CEOs at generic drug companies have also done well. Heather Bresch, who got into trouble because of the high price of EpiPen, was reported to have received $18.2 million in 2016.

What About Generic Drugs?

We firmly believed that the FDA was doing a fabulous job approving and monitoring generic drugs. That began to change in the spring of 1998. Here is what we wrote on May 18, 1998:

How good are generic drugs? For years, brand name manufacturers complained that cheaper knock-offs were inferior to their pricey products.

The Food and Drug Administration countered that generic drugs had to meet the same standards as the originals before they could be marketed.

Two letters from readers of this column make us wonder how well the FDA monitors generics after they have been approved:

“I have suffered from migraines for many years and taken Fioricet for most of that time. Recently I was in the midst of a killer migraine and asked my doctor for a refill on a prescription.

“The pharmacist had taken the liberty of giving me a generic to save me money even though I had not asked for it. I was disgruntled, but took the pills rather than be unpleasant.

“As soon as I took them they knocked out the headache and put me into overdrive. I was stimulated beyond belief–typing letters and sending faxes at 3:00 am. I was bouncing off the walls. The next day I was a complete wreck, definitely sleep deprived and with a horrible hangover effect.

“When I went to the pharmacy and mentioned the incident I was accused of eating chocolate or drinking coffee before bedtime. I assured the pharmacist I had done nothing of the sort.

“When I contacted the FDA it was a joke. Some clerk-type with no interest or knowledge finally called back a couple days later, promised an investigation and hung up. He called back the next day to tell me there was nothing wrong with the tablets, even though I never sent them to be tested.”

We have no way of determining exactly what was in those headache pills or why this patient reacted so strongly. But another reader had a bad experience with a different medication:

“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.

“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self. Why should this drug have affected me so?”

There are no easy answers, but these symptoms suggest that this reader might have gotten too high a dose of thyroid hormone.

Generic drugs are supposed to be chemically identical to their brand name counterparts. Hospitals, managed care organizations and insurance companies have embraced generic medications as a cost saving measure.

We are beginning to wonder whether that faith is always justified. People need to be as vigilant as these two readers were. If a switch leads to unusual symptoms it makes sense to contact the doctor and the pharmacy without delay.

As you can tell, we were starting to get suspicious. This Q&A was also published in our syndicated newspaper column in 1998:

Q. My mother was switched from Lasix to a generic furosemide for heart failure. Her feet started to swell and she had trouble breathing. As soon as we got her back on Lasix she got better. Any comment?

A. Your involvement might have kept your mother out of the hospital. Any change in medication requires close monitoring.

Where We Stand Today on Generic Drugs:

Since the spring of 1998 we have received thousands of complaints about generic drug quality. The FDA maintains that all is well and the agency has everything under control. The FDA brags about the number of generic drugs it is approving each year.

We remain concerned, however. Most generic drugs are now made abroad, in countries like Brazil, China, Hungary, India, Mexico, Slovakia, Thailand and goodness knows where else. Many of these plants may be perfectly fine, but when the FDA closely scrutinizes foreign generic drug companies it often finds problems. That is certainly what happened in India.

What Can You Do?

Do not assume your bottle of generic medicine was made in the U.S. under ideal conditions. Many foreign drug manufacturers have come up with very friendly names that seem home grown in the U.S. Again, we have nothing against foreign-made generic drugs if the quality is perfect. But our confidence has been shaken.

To learn much more about the FDA and its generic drug approval process, authorized generic drugs and brand name drugs sold in Canada at much more affordable prices, we offer our Guide to Saving Money on Medicine.

Share your own story in the comment section below.

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  1. Dan
    Reply

    The way I see it, generic or not, many of us are taking simply too many drugs. We have become a society of drug takers. A true drug culture. Many of the drugs that are prescribed are unnecessary. Simple changes in diet can work wonders. Simple solutions can be more effective and with fewer harmful effects.

    Pharmaceutical companies made $8 billion, per year, from the sale of ulcer treatments even though, in 95 percent of cases, the symptoms came back within a year. Once the drug companies stopped fighting the truth, it was finally acknowledged that H. pylori bacteria caused 80 to 90 percent of gastric ulcers. A simple solution for a problem that many, many folks were convinced they needed a pill for. And with good reason.

    I took one of these same OTC medications for indigestion for years, until I found that simply cutting out my daily intake of soda pop eliminated my need for this artificial chemical to make me feel better.

    Now, with the research showing that long-term statin use may only prolong your life by about 30 days, and only for 1.1% of users, it may be time to severely question everything the doctors tell you.

    And it may be time to consider giving up the drugs – after, of course, getting full counseling from your doctor, who probably learned all he knows about that hot new Rx while visiting one of the many resorts in Hawaii, Acapulco, or the Caribbean, that are sponsored by the drug companies. Just something I picked up, over a decade ago, while working at one of these “resources” used by drug companies to present their “educational” programs to the medical community.

  2. Elle
    Seattle WA
    Reply

    More conversation that I can handle! What is your bottom line here?

  3. L
    Georgia
    Reply

    Thankfully, the endocrinologists at VA Atlanta recognize this. The pharmacy has Synthroid rather than generic Levothyroxine. It does eliminate one possible area of concern and variable.

  4. Elizabeth A. Panus
    Buffalo, NY 14214
    Reply

    As a type I diabetic, my endocrinologist prescribed 5 mg of Crestor, more as a preventative. My HDL’s are routinely above 90. My insurance would no longer pay for Crestor, so my pharmacy gave me this TINY, yellow tablet, just with the letter “S”, no mg amount imprinted on the tablet either, as a Crestor generic.

    Suspicious, it took a while of online searching that I found that it was listed as a generic for Crestor, from Sun Pharma. in India. I NEVER experienced side effects from Crestor. The 5 mg tablet from Sun Pharma. gave me terrible leg and other muscular cramps, dizziness and lightheadedness. I immediately stopped taking it, told my Dr., who approved and I decided to NEVER take a drug from India again! Why isn’t the FDA and the pharmacies themselves protecting us from this poison!? Is it all about “trade agreements”? I dread if the TPP is ever passed with the new administration!

  5. Binkie
    Raleigh, NC
    Reply

    Can you suggest a plan of action for your readers as a group? Simply being vigilant is not sufficient when patients are hospitalized or when the patient is a child who cannot articulate or a senior with dementia. You have a wide and admiring audience. Let’s get something done. What do you suggest?

  6. Mary Lou
    Sudbury, ON. Canada
    Reply

    If the companies that manufacture the Brand Names wouldn’t charge such high fees, perhaps we seniors on small pensions could afford their brandname medicines. Instead, we have to go for generic ones, because even then, it’s a struggle to be able to afford drugs that we are taking for the remainder of our lives.

  7. Sandra
    NC
    Reply

    I’ve had rheumatoid arthritis for over 8 years. I have been using injectable Methotrexate once a week for several years with good results. Last year CVS switched manufacturers of the methotrexate from Netherlands to India, and I received vials of Methotrexate made in India for several months.

    I became progressively sicker with much more pronounced rheumatoid symptoms, getting worse over several months. When CVS begin supplying methotrexate manufactured in the Netherlands again, my symptoms started to lessen significantly within two to three weeks, and continue to be under control.

  8. Edwinna
    San Antonio, Tx
    Reply

    And now drug companies are raising the prices of generic drugs dramatically! Soon many of us will not ba able to afford generics either.

  9. Pete
    Chicago
    Reply

    These anecdotal examples, and I do realize that they represent many, are not in anyway reliable and should not be use by TPP to mean anything. This is fake news. This is the reason we have double blind studies. If my doctor gave me an aspirin and told me it was speed, I would be bouncing off the walls. If a person is given a generic and normally takes a name brand because he is apprehensive about generic’s of course he will feel different, this is the placebo effect.

    The FDA needs to diligently check drug companies products and if one pill is off formula FINE THEM AND SHUT THEM DOWN. After 3 times take their license away. If FDA does this randomly and without notice they don’t need a large work force.

  10. Bruce
    Reply

    I lost faith in generics years ago when a generic Metoprolol caused great problems…my Dr said it was all in my head but as soon as I switched back to the name brand (which cost 5X more) everything cleared up. Later I read that the generic I was taking was found to be manufactured incorrectly.

    • Fred
      Phoenix Az
      Reply

      The simplicity (and efficacy) of Bruce’s March 3, 2017 suggestion is staggering: just test a random bottle of pills purchased from a random retail pharmacy. If an anomaly is noticed, look deeper. If verified, slap the manufacturer with a HEFTY fine and require a discrete but immediate complete recall/replacement. Also return half the bottle of culprit pills for confirmation, and retain the other half for evidence. Invite the manufacturer to appeal within 30 days (this is a simple matter of fact gathering & presentation). If the manufacturer loses the appeal, require a PUBLIC recall, which will also open the door for a flood of lawsuits.
      Bravo!

  11. VIVIAN
    TexaS
    Reply

    I have to take twice as much generic estradiol made by Barr and Teva.

    I used to only have to take one mg of name brand Estrace and now 2-1/2 mg of generic.

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