I saw a urethritis patient the other day. I had given him samples of some antibiotics and he returned about 2 weeks after his initial visit, reporting that he did not see any improvement in his symptoms. However, he also told me that he did not take any of the antibiotics because he had read the package insert (PI) and found out all about the horrible side effects that the medication can potentially cause.
This included a litany of possibilities, including : headaches,dizziness, lethargy, hyperactivity, gastrointestinal distress, sun sensitivity, rash, liver damage, kidney failure, allergic reaction, sometimes severe enough to cause death, heart palpitations, heart failure, bone damage, fractures, depression, elation, weight gain, loss of appetite, blurry vision, hallucinations, halitosis,and persistant gas.
Now, I am "somewhat" making light of these potentially severe side effects, and if any of the serious ones were to happen, it is definitely no laughing matter. However, if you were to read any PI for any drug, you will find that the most horrible fate can befall you, should you choose to ingest the medication. They are written because 1) it's the law and FDA regulations mandates it, and 2) the drug company wants to CYA (Cover Your Ass). It's true that most "herbal" remedies don't have any of these precautions, but that does NOT mean they are safer. On the contrary, since they are not regulated by the FDA, they are not obligated to disclose anything.
The irony is that this particular urethritis patient was taking an herbal prostate remedy as well as ASA (aspirin) 81 mg every day because he had heard it was good for his heart. Though this is an OTC (over the counter) medication, it does not mean there are any less risks associated with it than a prescription medication. Now have you ever been bored enough to read the full PI for ASA???? It's absolutely frightful, and if it were a new drug trying to get approved by the FDA nowadays, it would probably fail miserably because of all its risks. Furthermore, acetaminophen (tylenol) toxicity is the most common cause of acute liver failure in the US. Yet how many of us actually read the PI for the OTC meds? How many of us have popped a couple of ASA or tylenol when we have a headache without giving it a second thought?
As a responsible physician, when I prescribe a medication, I always go over the most common side effects that particular drug can cause, and I don't dissuade any patients from reading the PI. On the contrary, I do want my patients to be as informed as possible. But please read it as an informed consumer, and if you have any medical questions about it, do ask me, in lieu of forgoing with the treatment altogether...
Sunday, June 04, 2006
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2 comments:
Well said,i applaud your blog,mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it's Zyprexa product causing my diabetes.--Daniel Haszard www.zyprexa-victims.com
An Oldie, But A Goodie
Almost on a daily basis, one may read about a new medication being developed or approved for the benefit of patients. At times, these announcements may praise the innovation and novelty of such new drugs that are available to all in need of it.
But it’s possible the one super drug is not new and really is a super drug. In fact, it’s one of the oldest medications available, and that would be aspirin- the first non-steroidal anti-inflammatory drug (NSAID).
Noted as ASA by doctors typically, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief. Yet due to the harshness of the natural chemical of this bark, Bayer decided to synthesize it to make it morefriendly to the user.
Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced ‘Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity due to the effects of this medication in need of relief.
While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.
With Aspirin and its potential life-extending benefits:
Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.
Aspirin has been the best selling painkiller absent of the past addictive qualities of opiate meds since the 1950s. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug.
Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.
Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons.
At times, something newer is not always better.
“There is no genius without a touch of madness.” --- Vaslav Nijinsky
Dan Abshear
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