drugs that disappeared

Recently, I was drinking my morning coffee out of my Vioxx mug. When Vioxx came out, it was BIG. Everyone was going crazy for this drug that was supposed to help pain and inflammation without the typical gastrointestinal side effects that those types of drugs usually caused. While Vioxx was pulled off the market a long time ago (more on this shortly), I still do love the mug and could not part with it! It got me thinking about how many drugs that disappeared because they have been pulled off the market since I have been a pharmacist.

To understand the process of drugs being removed from the market, I think it is important to review how drugs are approved in the first place.

FDA’s Drug Approval Process:

After preclinical/animal testing of a new drug, an Investigational New Drug Application (IND) is filed by the drug’s sponsor, asking to proceed with human testing.

If approved by the FDA, Phase 1 studies begin. These studies typically involve only 20-80 people and focus on safety and side effects.

Phase 2 will study several dozen to 300 people and looks at effectiveness.

Phase 3 will study several hundred to 3,000 people. Phase 3 looks at both safety and effectiveness.

Then, a New Drug Application (NDA) asks the FDA for marketing approval. There is a period of time where inspections of the facility used to manufacture drugs occur, labeling is decided, etc.

You can click here (https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm) for a comprehensive explanation to read about the process in more detail – this link also explains unique situations such as orphan drugs and accelerated approval, which is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments.

After Approval:

After a drug is approved, studies are supposed to continue to monitor the drug in Phase 4, the FDA’s post-approval risk assessment system. It is important to continue to look at safety issues even after the drug is on the market, because issues that may not have been predicted could arise. Serious, unexpected adverse events may be detected, and action can be taken when warranted. Although the FDA requires this follow up testing, there are concerns that the testing is not done completely.

MedWatch to Detect Problems:

Doctors and patients can report adverse events through the FDA’s MedWatch system. As risks or adverse events are discovered, they may be added to the drug’s labeling. If serious, use of the drug may be limited or, in rare cases, withdrawn from the market.

Drugs That Disappeared:

Let’s take a look at some of the more notable drugs that disappeared from the market, starting with the subject of my coffee mug.

rofecoxib (Vioxx):

Vioxx, classified as a COX-2 inhibitor, quickly became widely popular for pain and inflammation. In 2004, Merck announced that Vioxx would be withdrawn from the market after a clinical trial showed patients were at increased risk for heart attacks and strokes.

valdecoxib (Bextra):

Bextra, another COX-2 inhibitor, was removed from the market shortly after Vioxx. In 2005, drug maker Pfizer voluntarily withdrew Bextra from the market based on lack of adequate data on cardiovascular safety, and increased risk of cardiovascular events. There were also reports of serious and potentially life-threatening skin reactions from use of Bextra.

Interesting to note, while Vioxx and Bextra were both removed from the market, celecoxib (Celebrex), the other COX-2 inhibitor, remains on the market to this day, and is still very popular.

terfenadine (Seldane):

Seldane (a non-sedating antihistamine) and Seldane-D (terfenadine plus pseudoephedrine, a decongestant), were removed from the market in 1997 due to life-threatening drug interactions (interacting drugs included ketoconazole, erythromycin, clarithromycin, and even grapefruit juice). The company (Hoechst Marion Roussel, now Sanofi-Aventis) later released non-sedating antihistamine fexofenadine (Allegra), which is chemically similar to Seldane but does not cause life threatening drug interactions.

gatifloxacin (Tequin):

A fluoroquinolone antibiotic, chemically similar to well-known drugs such as Levaquin and Cipro, Tequin (made by Bristol Myers Squibb) was removed from the market after it was determined to cause both hyperglycemia and hypoglycemia. Gatifloxacin remains on the market today, but only as an eyedrop.

Ipecac syrup:

Who hasn’t heard of ipecac? Many years ago, this drug was a household staple that parents could buy over the counter and keep at home in case of poisoning. After decades of research, investigators concluded that though this drug indeed caused vomiting, there was little research to show that people who took this medication after poisoning did any better than others. It was also unsafe for anyone who swallowed chemicals that cause burns on contact or medicines that can cause seizures very quickly. Often, people with eating disorders would rely on this medication to induce vomiting, and regular use of this drug was linked to possible heart problems and death. Sometimes, people vomiting after taking this drug could not keep down other drugs that they needed to treat their poisonings. In 2003, the American Academy of Pediatrics issued a statement telling people to throw out this drug and instead focus on poison prevention, as well as calling Poison Control at 1-800-222-1222 for ingestion of a poisonous substance.

cisapride (Propulsid):

Another drug that was widely popular for a time, Janssen stopped marketing this drug in the United States as of 2000. Like Seldane, pharmacists and doctors were not at first aware of the very dangerous effects of this drug.

Use of this drug, which was given for severe nighttime heartburn not relieved by other treatments, was associated with reports of heart rhythm abnormalities, including 80 reports of deaths, many because of underlying conditions. As with Seldane, many of the serious complications were precipitated by interactions with other medicines. Although this drug is not available through pharmacies or wholesalers, doctors can request and obtain the drug through a limited access program.

These are just a few of the more notable drugs that have been withdrawn from the market. Although I searched several sites for a list of withdrawn drugs and reasons why, I actually was surprised to find that Wikipedia has a good summary of these drugs that disappeared (https://en.wikipedia.org/wiki/List_of_withdrawn_drugs)

Words of Advice from a Pharmacist:

It is scary to hear that a drug you or someone you know has been recalled. What can you do? You cannot predict that a drug that was supposed to help you in one way will turn out to be dangerous in another way.

Often, certain conditions can be managed without medication. For example, some people are able to lower their cholesterol and blood pressure through diet and exercise; some are not. It depends on a variety of factors, and everyone is different. Before starting a medication, ask your doctor what else you may be able to try. Usually if you can use a nondrug therapy, you will not be putting yourself at risk for complications.

Older May Be Better:

In general, I have always felt more comfortable with older, tried and true drugs than with new drugs, if only because their risks may be better known. Although I feel like many people are impressed with the promise of a new drug, for many conditions old drugs do the trick. For example, although new cholesterol drugs have since been approved, our most commonly dispensed cholesterol medication is still atorvastatin (generic Lipitor), which has been around for many years. To me, I would just feel more comfortable with a drug that has been studied for many years, especially if it’s a drug my doctor has put hundreds of patients on without issues. Bonus – Not only are they more studied, but they are more reasonably priced as well.

As always, this theory is not perfect. Recently a study came out that a very popular (and very old) drug, hydrochlorothiazide (this drug is prescribed either on its own or as a combination in many other drugs, for blood pressure) was linked to skin cancer.

Read Labels:

Which brings me to another point – read your warning labels. Many patients admit that they do not read the warning labels – those little stickers next to your label with little nuggets of information such as – do not drink alcohol, stay out of the sun, take until finished, etc. Not only is it important to read your warning labels, but it is important to read all of the information that comes with your prescription. I know it can be long and tedious, but it can save your life. Some of the drugs described above may have been safe on their own, but fatal when mixed with an interacting drug.

Avoid Interactions:

On that note, be sure every doctor you see has a full and updated list of all your medications. Keep your prescriptions all in one pharmacy so that interactions can be picked up by the pharmacist. Many commonly prescribed antibiotics can have dangerous drug interactions with common maintenance medications. Often they are prescribed by different doctors and the interaction may not be picked up. This is why it is important that your prescriptions are located in one central pharmacy. When you are starting on a new prescription, it makes sense to ask both the prescriber and the pharmacist to check for interactions. Don’t just take it for granted that they have done this.

Be sure your pharmacy has your correct, up to date, contact information. If you are like me and do not listen to your messages on your home phone, be sure the pharmacy has your cell phone as your primary contact number. There were several times over the years where we had to call patients to tell them their medication was recalled or taken off the market, and as a patient, you want to be sure you are reachable.

Keep Your Drugs Up to Date:

Clean out your medicine cabinet regularly. Discard expired drugs. While it may be tempting to pop an old antibiotic for a new illness, it is not safe.

Follow Your Doctor’s Instructions:

If your doctor tells you that you need to come back in 3 months for blood work, there is a reason and you should do that to make sure all your levels are within appropriate limits. For example, with cholesterol drugs such as Lipitor, your liver function must be monitored.

Listen to Your Body:

you know that saying, if you see something, say something? If you feel something that’s not right, say something – ask your doctor. Drugs that were withdrawn from the market started with patient reports of problems. Those triggered safety studies.

Chances are, your prescription medication will not be withdrawn from the market, and you will do just fine, but knowledge is power. Read the information your pharmacist gives you, communicate with your healthcare providers, and if something doesn’t feel right, speak up.

Information in this article is intended to be general information and is not individualized and is not a recommendation for treatment. Consult your doctor for personalized health information.

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  1. alan
    Reply

    I’m 74. Over a year ago, I was referred to a dermatologist for rosacea. During the general check he found some AKs which he shot with liquid nitrogen (first time ever!), then told me to come back in a year for follow up.

    Fast forward to this past February or March. During my checkup, my PCP decided that even though my hypertension was under control, because the standard had been tightened up, he determined that we’d “tweak” the Losartan Potassium to Losartan HCT. I vaguely remembered something negative about HCT drugs, but I agreed, and started a couple days later.

    End of April, I’m back to dermatologist who used a whole lot more nitrogen on the AKs PLUS I’m going back shortly for laser (?) treatment which requires 2 sessions and extreme care afterwards. I mentioned the HCT in passing & he didn’t argue it. Just said that my AKs are possibly precancerous.

    Straight to pharmacy to see if I could go back to my former Rx. Yes, I had 2 months remaining. so i filled it. Mentioned my situation & the pharmacist didn’t even blink: this diuretic – sun sensitivity. I will have a long, heart-to-heart with the PCP, believe me.

  2. Anne
    Vic Australia state-
    Reply

    I’m an avid reader of all kinds of health articles as i read the comments posted here interesting reads most meds that are so called removed instead get sent to 3rd world countries or recycled by new name i read a book called Cured To Death what a great book open my eyes up i take my health into my own hands & my dr & i will agree to disagree as ive researched my facts i know its not the drs fault as well the pressure placed on them by big phama & hospitals its about big business

  3. Lynne
    Reply

    The one I miss the most is Darvon 65. It took my pain away from my head to my toes, when needed, and was cheap. Now it’s gone. The only pain killers that I have seen (from a dentist to a pain specialist) are opiates. Since those are the ONLY pain medicines being prescribed, it seems, it is no wonder “they” think we have an opiate epidemic going on…and they don’t work as well on me as Darvon 65 did!

  4. Lyn
    Reply

    My specialist insisted I take Vioxx, even though it caused severe pain in my stomach. He was rude, paternalistic, and so I finally found another MD, stopped taking Vioxx, and the pain in the stomach disappeared. I have also taken Cisapride, and at the time didn’t know why my Dr. took me off of it. I have found over the years that I am hypersensitive to many drugs, and always take care when starting a new medication.

    Read the pharmacy printout thoroughly, listen to your body, and report any abnormal symptoms after being put on a new drug, and try not to take two new drugs at the same time so that you will know which one is causing an issue.

    I believe that not only big pharma, manufacturers and distributors are at fault for pushing drugs on patients that cause harm. The FDA needs to be re-organized, the rules for testing stringently adhered to, without “exceptions,” when a company tells them they’ll do a study on an old drug that they’re loosing the patent on, that never comes to fruition, as well as other exceptions. It would behoove the US to manufacture drugs our country, rather than buying them from around the world, where the FDA can’t investigate best practices and what truly goes into a generic or new medication.

  5. Lynn
    midwest
    Reply

    The pharmacist gave great advice. But I have practical problems with having all your prescriptions at the same pharmacy. I have one Rx at a major mail order pharmacy through my health insurance. My health insurance has another of my prescriptions, a biologic, through a different companies specialty pharmacy. I have one Rx at a compounding pharmacy and finally, my desiccated thyroid, is bought in my doctors office because it is hard to get at a pharmacy with consistancy.

    I would imagine many folks also find that they go to more than one pharmacy due to price differences. While it makes sense to have all Rx at the same pharmacy, how many people are able to do this?

  6. Joyce
    Boca
    Reply

    terfenadine (Seldane) sent a colleague of mine into the hospital with blood pressure that was astronomically high. Allegra (fexofenadine) raised my blood pressure to an unsafe level. The generic names are similar, and I wonder how many people are having blood pressure problems caused by Allegra. No one would think to suspect their allergy medication.

  7. Mary F
    Texas
    Reply

    Years ago my doctor prescribed Vioxx for me. I took it as directed. I experienced extreme tiredness while on it. By the early afternoon, when I got off work, I would get on the couch and fall asleep. It wiped me out. I was so tired. I explained this to my doctor and that day the rep was there. The doctor reported this to the rep who said “Oh no, this is not a side effect”. She basically ignored my complaint. I got off this medication right away. I could not function. When I read the it was being taken off the market, I read a side effect was extreme tiredness. My doctor listened to me but the rep did not.

  8. Deloris
    Reply

    The FDA’s MedWatch system is a joke. Doctors seldom report adverse drug effects, often blaming them on something else or citing lack of time. And when patients themselves report adverse effects, those reports are given less weight in drug safety evaluations. I believe this is why many dangerous drugs are still prescribed without reservation and getting any warnings included on a drug label takes a ridiculous amount of time and only after many unnecessary delays.

  9. Louise
    Carbondale, IL
    Reply

    When I was discharged from the hospital after a major surgery in 2001 I was given a Rx for Oxycontin. I said No, thank you, because they gave it during my stay and I noticed my brain function was seriously affected. I told someone it was like it turned to powder and floated away. I said I have some Darvocet at home and will take it if needed for pain. That was a standby for occasional back pain and I never needed anything stronger. Then suddenly it was off the market, I heard because of a law suit. Nothing else has been satisfactory as Nsaids are negative for kidney function.

  10. Lin
    Chas., SC
    Reply

    After taking a diuretic for about 2 weeks, my heart fluttered, went into A-fib and stopped. I had a myocardio infarction that was brought on by the loss of potassium and magnesium.. My primary care physician never told me about the need to monitor potassium, i.e, eating a banana. Four days earlier, the ER physician at a major hospital (MUSC in Charleston, SC)told me my symptoms were indigestion. This is a frequent misdiagnosis for women having a heart attack. Why didn’t this teaching hospital know that? My new primary care physician put me on diltiazem 180ER. The first night that I took it, I urinated 5 times, beginning 15 minutes after taking it. My cardiologist and primary care physician both say it wasn’t caused by diltiazem. An allergist said 2% of patients have my reaction. Now, after taking diltiazem for a year, I have experienced significant loss in bone mass in my hip, pain in my hip and legs as if in my bones and the frequent urination continues.Often there is discomfort in my lower and back area. My doctor said maybe I am experiencing anxiety. Why should the experience of dying from a heart attack and watching drastic changes in my body functioning cause any anxiety? Why should I expect to be as active and as well-functioning as I was before the heart attack and before taking diltiazem use? Why do doctors label you rather than work with you to discover the truth?
    I knew my body before they did.

  11. ladyliza
    Los Angeles
    Reply

    I don’t trust doctors any more than I trust the CDC, AMA, AHA or any other government body. Doctors very often just listen to the drug salesmen instead of researching the drugs themselves before prescribing them, and doctors often receive kickbacks in the form of cash, trips, or both. I, for one, research any and all drugs that I or my animals must take before I fill the prescription. I also look at natural cure websites for ways around taking the drugs in the first place. This way, there are no side effects to worry about, or very few. That also includes any and all vaccines. Since I have stopped getting the flu shot, (about 12years ago,) I have never gotten sick, not even a cold. Before, I used to get 2 colds per year. There are easier ways to prevent illness, like washing your hands when you come home, and wash often during the day and keeping vitamin D levels at between 60-70 on the blood test.

  12. Brent Bielema
    NW IL
    Reply

    My relative did have a heart attack and did have some Vioxx samples around, but I don’t know if they ever took it. If we could find the medical records to find out what was taken, we might have had a case there. So definitely when you are prescribed any drug, make sure you do plenty of research and see if there is a less-risky and preferably natural treatment to avoid needless suffering. Thanks for posting this important article!

  13. JUNEBUG14
    Houston, TX
    Reply

    Thank you, Peoples Pharmacy, for a great article! My father had a bad reaction to Darvocet many years ago. great to find out why after all this time! Very interesting, indeed!

  14. MMV
    Florida
    Reply

    Does anyone keep track of side effects that aren’t listed or expected? Ambien kept me awake for 3 days. The “oxy” pain killers gave me a horrible headache – so bad I couldn’t move my head for hours. PPIs resulted in joint pain, stiffness and swelling that sent me to my rheumatologist to see if I was in an arthritic flair. When I try to discuss this with the prescribing physicians I am more or less dismissed because my reactions aren’t on the list, but no plausible reason is discovered, or even investigated. “Some people just don’t process medication well.” But they still want me to take a statin (the ones I tried made my numbers go UP along with joint and muscle pain, brain fog and an overall not feeling well). So I take only what I feel I can handle.

  15. Bob
    Riverton, Utah
    Reply

    The information sheets that accompany drugs are typically printed in ways that violate all of the principles of good text design and typography, e.g., small fonts, long lines of text crowded too close together, very little white space, long convoluted sentence structures, lots of undefined technical jargon and abbreviations. These things increase the effort required for reading, and reduce comprehension. This type of presentation often indicates that someone prefers that you don’t read or understand the material.

  16. Wendy
    Reply

    I reviewed the listing of discontinued drugs and didn’t see Avandia, a Type 2 diabetes drug that was taken off the market years ago because of a higher risk of heart problems. That was the first medicine that I took when first diagnosed 18 years ago. Other than a 10 pound weight gain that I was eventually able to lose, I had no other side effects. It worked so much better than what I am taking now which has given me off and on digestive problems. Just wondering if Avandia is back on the market?

  17. Deborah
    Desloge, MO
    Reply

    I was seriously and permanently injured as a child. I later entered the healthcare field. The physical demands resulted in pain, and I was prescribed Darvocet. It was an effective deterrent, and I took it only occasionally for 20+ years. Darvon and Darvocet were very old medications, and suddenly they were removed from the market. I had no other options for relief except hydrocodone, which I still take as needed, periodically. I find I often go through my day in pain because I fear addiction.

    My question: how did it take 30+ years to discover such strong side effects that the medication must be completely removed from the market? Often, I have seen older medications removed from the market, as more affordable generics became available. Then a new version returned to the market with a minor change in the formula or delivery system and serious price increases.

    I’ve always suspected Big Pharma was in the pocket of so many politicians who succumbed to the pressure to have it removed.

  18. Bill
    Reply

    Which class of drugs has had the most withdrawals from the market?

    My guess is that it is the quinolones.

    According to the following article, FIVE quinolones have been withdrawn from the market.

    https://floxiehope.com/2016/07/20/fluoroquinolones-removed-from-the-market/

    FLUOROQUINOLONES REMOVED FROM THE MARKET

    1. Omniflox / temafloxacin

    2. Raxar / grepafloxacin

    3. Zagam / sparfloxacin

    4. Trovan / trovafloxacin

    5. Tequin / gatifloxacin

    According to the article, “The fluoroquinolones that have been removed from the market are not terribly different from the ones that remain on the market in terms of damage done or damage mechanisms.”

    I’m not eager to take a quinolone antibiotic, especially due to potential tendon damage.

  19. dana
    Reply

    Is it safe to assume that these medications carry the same risks in veterinary applications?

  20. Marcia
    Reply

    I had no side effects from Vioxx or Seldane. Vioxx is the only medication that helped with my arthritis pain. Celebrex was useless. All medications have side effects. Vioxx should never been taken off the market, same thing with Seldane. It worked fine for me. Name one medication that doesn’t have side effects.

    • Rosemary
      Florida
      Reply

      I took Seldane for my allergies and when it went off the market, the only place to get it was Canada or Mexico. Then they stopped shipping it. Allegra does nothing for me.

  21. NeNe
    Florida
    Reply

    I recently had severe blood sepsis with an 8-day hospitalization. It was caused by the sudden appearance of a kidney stone which stopped the flow of urine. I believe it was caused by the drug Jardiance. This drug can cause dehydration and “sudden acute kidney injury”. This happens most often in the first few months of treatment. The elderly are at most risk. I reported it but the reporting process is time- consuming. You also have to be very computer savvy. I believe others are suffering unreported.

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