The FDA has a mandate to make sure all drugs (prescription and OTCs) are “safe and effective.” This is the law. The only trouble is that FDA’s definition of ‘safe’ is hard to get a handle on.

The feds routinely approve drugs that have life-threatening side effects. This is completely understandable in the case of a drug that might cure a deadly cancer. It is inexcusable when it comes to a condition like arthritis, high blood pressure or diabetes.

Avandia is just the latest in a long list of FDA disappointments. The FDA has been slow to discover serious problems with medications and often drags its feet even when the warning bells are clanging.

PPA (phenylpropanolamine), for example, was a decongestant and diet aid that was found in both prescription and over-the-counter products. It was introduced in 1962. Over the years, a number of experts warned that this drug might predispose people to heart attacks and strokes. Still, it took the FDA until 2000 to ban it. Countless people suffered and died because of FDA’s delay.

There are so many other examples we don’t know where to start. The non-sedating antihistamine Seldane was introduced in 1985. Even though doctors reported that some patients suffered sudden cardiac arrest when they took Seldane in combination with certain other drugs, it took the FDA until 1998 to ask the manufacturer to take this allergy medicine off the market. The agency waited until the manufacturer had a replacement product, Allegra, ready for sale.

Vioxx got a lot of ink when its manufacturer admitted that the drug could increase the risk of heart attacks and strokes. Again the FDA was late to the show. We asked an officer of the agency why they didn’t discover this serious side effect themselves and were shocked to learn that the FDA has a very hard time detecting “common” complications such as heart attacks or strokes.  

Now we are told that one of the most popular diabetes drugs (6 million people are taking it worldwide) can also increase the risk of heart attacks and premature deaths from cardiovascular causes. Avandia has been on the market since 1999. It is only because of the persistence of Steven Nissen, MD, (Chairman of the Cleveland Clinic Department of Cardiovascular Medicine) that we learned about this problem.

Dr. Nissen is a bulldog. When he suspected that there was trouble with Avandia, he tracked down studies to assess cardiovascular risks. Why didn’t the FDA figure this out itself and warn physicians sooner?

People taking Avandia should NOT stop taking their medicine. If the risk is real, problems rarely develop overnight. It is a long-term process. Nevertheless, it would be prudent to schedule an appointment with the doctor who prescribed Avandia to discuss other options for diabetes control.

We deserve safe and effective medicine, just as the law says. To get there, though, FDA will have to do a much better job designing drug studies and monitoring medications once they are approved for sale. Until the FDA really protects us, we the public will have to be more vigilant, more skeptical and slower to accept prescriptions for the newest, most popular drugs.

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  1. Jeanette B.

    I have type 2 diabetes. I developed high blood pressure and my doctor put me on HCTZ. My blood glucose soared. I saw a comment in a magazine about HCTZ and bg and mentioned it to my doctor. He changed my BP medicine to Lisinopril and my bg dropped overnight.

  2. Fred//Manhattan

    For 7 years I took avandia and metformin. Always then had difficulty focusing on the here and now, was absentminded, and slept too much. Also blood pressure was way too high (160/100) and heart beat too high (95/minute). Also after severe jetlag (6 hour time difference or more) often irregular heart beat forcing me to go to bed and sleep it off (scary and bad for business).
    All the doctor did was give me more blood pressure pills. I decided to do it myself, stopped taking the metformin and avandia and cut blood pressure pills by half and (obviously) lots of physical exercise (am about 60 so not too difficult).
    Results 100% improvement: sugar level is fine, blood pressure 120/70, heart beat back to 80/minute. My conclusion is that avandia and metformin are very dangerous pills and that doctors just don’t see the negative spiral in overall health it causes.

  3. V.L.

    Male, active, 5’10” never overweight, steady 180 lbs. Non smoker. Only daily medication was Triam/HCTZ twice daily. At the age of 70, I came down with diabetes 2. No family history nor any prior indication (annual blood work and physicals) of this onset. The endocrinologist immediately put me on daily insulin injections for about 5 or 6 months and I had to be very cautious about hypoglycemia once or twice a day — even awakening at night to experience that condition a few times.
    He then placed me on Avandaryl, one half pill, 4-4mg daily. The Avandaryl had to be halved due to hypoglycemia almost on a daily basis when on a morning one-a-day basis. This medication continued for about 5 or 6 months. He abruptly stopped the Avandaryl about 6 months ago and prescribed Glimepiride 4mg (one/day). He had me split the pills due to my experiencing hypoglycemia around 10 or 11 a.m. quite often. The half-pill, twice-a-day has mostly alleviated that problem. Incidentally, my daily readings were under 100 on the Avandaryl, about 100 to 110 on the Glimepiride, and the A1c taken every 3 to 4 months, is around 6.0.
    My concern is rising blood pressure readings. My daily morning readings were about 170 to 180 over the low 80’s regularly. Now they are all over the chart — one morning, as low as 133/79 and the very next up to 180 or 190 over 100! Anyone else experiencing these conditions?

  4. C. Hall

    I took Avandia for a few years and between it and the Metformin, my blood sugar counts were pretty well controlled. One morning, I woke up almost 30 pounds heavier, heart palpitations, exhaustion, my clothes were suddenly miserably tight, etc. I finally got an appointment with my Doc and he IMMEDIATELY zoned in on the Avandia.
    He replaced it with Januvia which did me NO good whatsoever. When I hear of these drug warnings for medications my elderly parents and I take, I don’t wait for the Doc to bring it up, I do myself. I have to be responsible to and for myself & those dependent upon me. I just hope doctors are warning their Avandia patients of what side-effects to look for.

  5. sue

    My mother was given avandia for a trial prescription, It was a horrible experience, she was 85, it gave her diarrhea, she began to retain fluid, so was put on a diaretic and then potasiumm plus more blood pressure med. the one thing it did not do was lower blood sugar, I really think this drug is what caused her demise and death, even though she was taken off that and put on insulin, too late.

  6. fdk

    after taking avandia for my type 2 diabetis for the past three years, my doctor suggested it might be safer to take metforman,and glyburide. I tried metformin, it cause 24 hr gastro discomfort, and the glyburide did nothing to bring down my sugar level. I asked my doctor to put me back on avandia (6 mg daily), however, shortly thereafter, i put on 10 lbs in less than one month. What do suggest. fdk, queens, ny

  7. J Chapin

    My mother was also taking Avandia. There is a website, that has a lot of links to medical news about Avandia but you can also search their database for adverse drug reactions with any drug. After speaking to my mother about everything I learned I urged her to talk to her Doctor who did take her off Avandia.

  8. Donna Carter

    My 86-year-old father had been taking Avandia. When concerns began to appear via the media, I did my own research and had him taken off because of fluid retention. The difference is amazing. He had had two liters of fluid removed from around his lung twice, and his pant waist size had increased several times over a short period. All of the fluid is gone now that he has been off of Avandia for awhile. The doctors could not determine what had caused the fluid build-up, but I was relieved that I figured it out. I do not know if there is a way to report these circumstances as another reason for Avandia to be reconsidered in the treatment of diabetes.

  9. Thelma H. Zuniga

    I have a friend who has just had a terrible reaction to the drug Chantix. He was taking it to help him stop smoking, but ended up in the hospital with convulsions. Do you have any information on the side effects of this drug?

  10. mike o'brien

    Avandia is another example of regulatory failure,among others. Even in the best designed trials, there is an unknown about any substance. These unknowns present themselves over time through many complex interactions that occur beyond the controls of experimentation-in real life. Historically, it takes time after making a drug market avail. for side/adverse reactions to occur. Both terms that are like FDA’s “safe and effective”. Why does the FDA have problems w taking action when medication complications manifest themselves to the highest level, mortality? Its the Triple Helix, a triage of educational institutions,governmental organization(FDA) and corporations(pharmaceutical interests). In a Triple Helix, one thread can crossover and replicate the other or assume the role that the other plays. The Triple Helix is an important construct that has high validity and applicability in many challenges we face now and in the future,particularly in dev. medicines and monitoring their usage history.

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