Archive for the 'Medication' Category
March 9th, 2010 by Nina Thompson, ARNP
Avodart (dutasteride) may both prevent prostate cancer and improve the predictive power of the blood test, PSA, according to researchers from the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. In their recent study of men with benign prostatic hyperplasia (BPH), the medication was associated with a 40% lower incidence of prostate cancer diagnosis than the BPH drug tamsulosin (Flomax) in at-risk men.
Several other trials have also found similar results. The American Society of Clinical Oncology and American Urological Association recommends that healthy older men discuss this with their doctors.
About Benign Prostatic Hyperplasia (BPH)
Source: “Prostate CA Prevention Affirmed for BPH Drug”, MedPage Today, March 07, 2010
Gomella LG, et al “Effect of dutasteride on the detection of prostate cancer in men with benign prostatic hyperplasia in the combination of dutasteride and tamsulosin (CombAT) trial” ASCO GU 2010; Abstract 28.
March 5th, 2010 by Nina Thompson, ARNP
More and more products with unidentified and harmful ingredients are finding their way into the booming U.S. “Dietary Supplement” marketplace. They are freely advertised on the radio and TV, and are readily available online as well as on the shelves of local grocery stores, pharmacies, and health food stores across the U.S.
This booming multibillion dollar market falls under the category of “Dietary Supplements” which are vitamins, minerals, herbs and other substances meant to improve your diet or overall health. They are most often advertised as “Natural”, which can often be far from the truth.
“Natural” is an abused word which has become an effective tool of this rapidly growing industry. In fact, many of the so-called “Natural” dietary supplements on the market may not even be what they say they are on the label. Even if they are pure, they still may well have significant adverse effects or interact with commonly prescribed drugs. A good example of their potential danger is that many are well known to interact with anesthesia during surgery.
The “Dietary Supplement” market is essentially unregulated by the FDA. Unlike prescription or over-the-counter drugs, which must be tested and reviewed before they’re sold, federal laws allow the sale of untested, unreviewed, and unregistered Dietary Supplements. So a very dangerous product may be on the store shelves and in your body for quite a while before it’s even reviewed or investigated.
Herbal drugs, claiming to provide miraculous cures for common ailments such as obesity, depression, anxiety, sexual problems, menopausal symptoms, arthritis pain and many others boast safe and natural relief without any side effects. This is absolute nonsense. These supposed remedies may well have dangerous side effects that you will probably discover sooner or later.
These products line many shelves of grocery stores and pharmacies and only the manufacturer itself is responsible for determining that the claims on their labels are accurate and truthful. The products are not even registered with the FDA, and only if the FDA becomes aware of false or misleading claims will the agency take action.
On the other hand, a large number of useful and therapeutic herbal products certainly are on the market, but finding them is a challenge. Do your research before making a purchase. Consumer Labs Online is one reputable source, and your health care provider is another good reference. In fact, it’s important to inform your doctor about any supplements you’re taking. Too many patients make the mistake of assuming that anything purchased over-the-counter is okay, and there’s no point in mentioning it to their doctor.
The law which eliminated the FDA review and testing of dietary supplements was the Dietary Supplements Health and Education Act (DSHEA), which was passed in 1994. Over the years since then, serious health problems have occurred with several different dietary supplements, prompting experts to call for a change in the current law.
Many, including the FDA, are saying this law needs to be changed, but while we’re fixing that law, others are saying that the FDA itself, needs to be reformed. Many people who love their “Natural” products, express their distrust of prescription drugs, and point out that many serious errors have occurred with drugs that have been approved by the FDA. Many experts agree that this is an unfortunate trend, and chronic underfunding of the FDA is said to be a major cause of this problem.
In any event, sticking only to “Natural” products is not the solution. Try to find a health care provider you trust, and make every attempt to be educated, beware and be skeptical of claims that are too good to be true.
Source: “Overview of Dietary Supplements”, FDA
Source: Consumer Labs, “Chromium Supplements (including weight-loss formulas”, March 2010
Source: “What’s in Hydroxycut?”, Kristina Fiore, MedPage Today, May 08, 2009
Source: “Reflections on Hexavalent Chromium: Health Hazards of an Industrial Heavyweight”, Environmental Health Perspectives, National Institute of Environmental Health Sciences, National Institute of Health, September 2000
Source: “New England journal endorses institute’s proposals for FDA”, BMJ. 2006 October 14; 333(7572): 772FDA
February 18th, 2010 by Nina Thompson, ARNP
An aspirin at least two days a week significantly reduced the risk of death from breast cancer by 64% to 71% in a recently published study from Harvard and Brigham and Women’s Hospital in Boston.
This study included 4,164 female registered nurses diagnosed with early stage breast cancer. The use of aspirin in the first year after breast cancer diagnosis was excluded in this study since the drug is discouraged during chemotherapy.
The dose of aspirin was not specified in the study as methodology was limited by self-reporting for aspirin intake. The researchers speculated that most regular use of aspirin is for heart disease prevention at the 81 mg/day level.
“These are promising findings, and if they are confirmed in additional clinical trials, physicians may be able to regularly recommend aspirin to their breast cancer patients to reduce risk of cancer spread and mortality,” wrote Lori Pierce, MD, of the University of Michigan in Ann Arbor, on behalf of the American Society of Clinical Oncology, in a prepared statement.
Previous studies have also found benefits of aspirin in relation to breast cancer. In September of 2009 the American Cancer Society wrote, “some studies have found that women who take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen seem to have a lower risk of breast cancer. These, as well as several other drugs and dietary supplements, are being studied to see if they can lower breast cancer risk, although none are approved for reducing breast cancer risk at this time.”
Daily aspirin therapy is also thought to help lower the risk of heart attack and stroke in certain people, but it isn’t appropriate for everyone. Doctors often recommend daily aspirin therapy in some people who’ve had a heart attack or stroke, or who are at high risk of either.
It’s important to note that breast cancer patients should always consult their oncologist or general physician before taking aspirin, especially during the chemotherapy, as it is often discouraged.
Anyone who wishes to start on aspirin should always consult with their physician as there are several potentially dangerous side-effects of this drug:
- The anticoagulant effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for its preventive anticoagulant effects only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding.
- Aspirin can irritate the stomach or cause GI bleeding. Aspirin should always be taken with food, preferably after a meal due to its potential for stomach irritation and GI bleeding.
- Aspirin is also contraindicated in: people with allergy to aspirin or NSAIDs (Advil, Motrin, Alleve, etc), 3rd trimester pregnancy. Precautions: History of asthma or peptic ulcer, severe hepatic (liver) or renal (kidney) dysfunction, bleeding disorders, diabetes, gout, pregnancy or nursing mothers. Aspirin interacts with many medicines. For more contraindications and a list of drugs that interact with aspirin, click here
- Children and teen-agers suffering from flu-like symptoms, chickenpox and other viral illnesses shouldn’t take aspirin or aspirin products (acetylsalicylic acid / salicylates) because of the possibility of a deadly disease called Reye’s syndrome.
Source: “Aspirin Benefit Seen in Established Breast Cancer”, MedPage Today, February 16, 2010
Source: Holmes MD, et al “Aspirin intake and survival after breast cancer” J Clin Oncol 2010; DOI: 10.1200/JCO.2009.22.7918.
November 21st, 2009 by Nina Thompson, ARNP
Brand named drugs are becoming more and more expensive these days and many people just can’t afford them. Often insurance companies won’t pay for a brand name if a generic equivalent is available, so more than ever people are faced with the question–are the generics equally effective and safe?
Both the FDA and generic drugmakers say that the generics are clinically identical to the brand named medications, but is this always the case?
Generic drugs have to meet the requirements of the FDA which requires ”90% confidence intervals for maximal concentration and the area under the concentration-time curve must be no less than 80% and no more than 125% of the means for the branded drug”, according to MedPage Today. In other words, yes there can be some variation.
This variation may or may not be a problem. It can be serious if the disease requires very specific blood levels of the drug, however, such as in a seizure disorder.
Carbamazepine (Tegretol) is a drug used to treat seizure disorders. The levels of the drug need to be predictable, reliable and effective, otherwise a seizure may occur. In a recent study at John Hopkins University, generic versions varied markedly in FDA-sanctioned bioequivalence studies. So in the case of carbamazepine, this variability could have significant clinical consequences for patients who switch from the branded product or from one generic version to another.
Another drug of concern is generic thyroid. Fortunately a blood test (TSH) can determine if you’re getting the right amount of thyroid medication, but it should only be done two months after taking the medication on a daily basis. Also, the problem might arise if the pharmacy switches generic brands, which they have been known to do. So if you have a choice, choose the brand name when it comes to thyroid medicine. If you’re forced to take the generic option, let your doctor know and pay attention to the color and appearance of the pill. If it ever changes, ask the pharmacist. If the pharmacy does switch generics, let your doctor know so a blood test can be scheduled.
As a health care practitioner, I’m concerned about generic alendronate (Fosamax). While the generic version may contain the correct amount of the drug, you may not be getting the absorption needed for it to be effective. This is particularly important for medications that have poor GI absorption to begin with. The absorption of the generic may be even worse than the brand name with the end result being little or no benefit when it comes to improving bone density.
Venlafaxine (Effexor), a popular drug for depression was recently studied by Franck Chenu, PharmD, PhD, of the University of Ottawa. The researchers found that the side effects of the generic version was three times more common than with the branded version, Effexor. Their findings were reported in the July 2009 issue of the Journal of Clinical Psychiatry.
When it comes to generics it’s always a good idea to talk it over with your doctor before you make the decision of generic versus brand name. And if you can only afford generic, let your doctor know.
Source: “AAN: Wide Variability in Generic Versions of Epilepsy Drug”, MedPage Today, May 1, 2009
Source: “Generics versus Brands: Are They Really Equivalent?”, MedPage Today, August 25, 2009
June 8th, 2009 by Nina Thompson, ARNP
Actos (pioglitazone), an oral drug used in Diabetes, appears to slow the rate of atherosclerosis in the carotid arteries, according to researchers at the Phoenix VA HealthCare System.
In their recent study, prediabetic patients taking pioglitazone preventively had a 38% lower rate of change in atherosclerotic progression in the carotid artery over three years compared to patients taking placebo.
Cholesterol is a waxy, fat-like substance made in the liver, but also is found in certain foods. Throughout life, beginning in childhood, there is a gradual build up of cholesterol and other substances on the inner lining of an artery referred to as atherosclerotic plaques. In Diabetes, the rate of atherosclerosis progression is even more accelerated.
Over time, these plaques can harden and narrow an artery enough to slow or even block blood flow. The illustration above shows the build up of an atherosclerotic plaque on an artery wall.
Atherosclerotic plaques are often unstable and can rupture into the vessel lumen causing a blood clot to form. This can result in a sudden blockage of an artery. This is often the process by which people experience heart attacks or strokes. In some people, the first sign of atherosclerosis might be a heart attack or even sudden death.
Diagram courtesy of the National Heart Lung and Blood Institute (NHLBI).
Reaven PD, et al “Pioglitazone reduces long-term progression of carotid atherosclerosis in IGT” ADA 2009; Abstract 15-LB.
June 1st, 2009 by Nina Thompson, ARNP
Your liver is a vital organ–you can’t live without it, and the symptoms of serious liver damage are extremely unpleasant, if not tragic. Liver disease is often preventable, yet the incidence is on the rise and very common — one in 10 Americans suffer from liver disease.
Many people think liver disease is solely alcohol-related. Although alcohol is a common source of liver damage, there are many other causes of liver disease. In fact acetaminophen toxicity is the leading cause of acute liver failure, according to researchers from the University of Washington.
Acetaminophen (Tylenol) is the most widely used pain reliever and fever reducer in the United States, and it’s a common ingredient that’s readily available in most parts of the world, but it causes more overdoses and overdose deaths, due to liver toxicity, than any other drug in the United States.
This is due in part to it’s toxicity but also because it’s a common ingredient and very easy to obtain.
Some people deliberately take toxic doses of acetaminophen in suicide attempts, but a significant number of others have accumulated damaging levels of the drug unintentionally when they took two or more acetaminophen-containing products simultaneously. Anything more than the Tylenol package-recommended 4 g/day — has been associated with severe liver damage. Adding a glass of wine or two on top of the overdose adds even further insult to the injury.
In fact as few as three alcoholic drinks at one time, when combined with certain over–the–counter medications, such as those containing acetaminophen, may have toxic effects on the liver.
Acetaminophen is widely available in over-the-counter preparations for headaches, colds, allergies, osteoarthritis, and other conditions. A person who is miserable from a cold might take Tylenol to relieve their headache, for instance, and then take a combination cold remedy which also contains acetaminophen. This can easily amount to an acetaminophen overdose. To make things even worse, drinking a glass of wine on top of the acetaminophen overdose would potentially deliver even more serious damage to the liver.
Acetaminophen is also found in prescription narcotics used for pain control, such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).
Read more: “Six Facts Everyone Should Know About Tylenol” from Bay Area Medical Information
Image courtesy of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.
Source: Larson AM et al Acetaminophen-Induced Acute Liver Failure: Results a United States Multicenter, Prospective Study. HEPATOLOGY 2005;42:1364-1372.
Source: American Liver Foundation
February 6th, 2009 by Nina Thompson, ARNP
More than 60 generic drugs have been recalled, some of which include commonly-prescribed metoprolol succinate, hydromorphone HCl, amlodipine, benazepril, benzonate, hydrocodone, morphine, oxycodone, as well as more than two dozen prescription prenatal vitamins and iron supplements.
In its fourth recall in the last four months, ETHEX Corporation announced the latest recall, noting that the products “may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices”. Manufacturing defects included over-sized tablets that delivered higher-than-labeled doses, according to the FDA, and the recall was done as a precaution.
The FDA began investigating the company’s manufacturing and quality control practices late last year. KV companies have issued a total of eight recalls totaling more than 200 products since May 2008.
For a list of recalled products and specific advice to consumers who are taking these drugs, go to the FDA’s website: “ETHEX Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level” FDA Press Release, Feb 3, 2009
January 12th, 2009 by Nina Thompson, ARNP
More and more products with unidentified and harmful ingredients are finding their way into the U.S. marketplace, and the FDA is quickly taking action to file criminal charges and help ensure that these products are removed from the store shelves. It is an extensive process, however, and dangerous products are still advertised on the TV and radio and readily available online as well as on the shelves of local grocery stores, pharmacies, and health food stores in the U.S.
Most of the dangerous and illegal products are for weight loss, but there are also many for erectile dysfunction, diabetes and hair loss. Usually they are labeled as dietary supplements or supplements. Often the manufacturer is not listed on the label or in the advertisements. However, the FDA has discovered that most of the products with illegal and undeclared ingredients have been manufactured in China.
Some of these ingredients are known to be carcinogenic and cause damage or mutations to DNA. Other known side effects include increased blood pressure, stroke, tachycardia, seizure, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts.
The FDA urges all consumers to be aware of the following signs of health fraud:
- Promises of an “easy” fix for problems like excess weight, hair loss, or impotency.
- Claims that the product is safe because it is “natural.”
- Claims such as “scientific breakthrough,” “miraculous cure,” “secret ingredient,” and “ancient remedy.”
- Impressive-sounding terms, such as “hunger stimulation point” and “thermogenesis” for a weight loss product.
- Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
- Promises of no-risk, money-back guarantees.
In other words, if it’s too good to be true, it is. The only OTC drug approved for weight loss in the United States is Ally. Orlistat is the active ingredient in Ally which helps produce weight loss by decreasing the intestinal absorption of fat. Some people have lost weight with Ally, but there are a number of people who shouldn’t take Ally. Click on the link below for more about Ally.
Read more:
January 9th, 2009 by Nina Thompson, ARNP
Osteonecrosis of the jaw, as a complication of dental procedures, has occurred in 4% of patients taking oral alendronate (Fosamax), whereas none of those who didn’t take the drug experienced any complications.
Fosamax, as well as Boniva and Actonel, are oral bisphosphonates. Fosamax is the most widely prescribed oral bisphosphonate, and in 2006 it was the 21st most prescribed drug overall.
In an article in MedPage Today, the the researchers are quoted as saying, “…if patients are using bisphosphonates, dentists should consider alternate treatment options for non-necessary extractions and good oral hygiene should be achieved before extractions to minimize microbial load. Also, follow-up should be more vigilant and a chlorhexidine rinse pre- and post-operatively ‘can be effective’ in ensuring socket and wound healing and mucosal coverage of exposed bone…”
These findings are preliminary, but if you’re taking any one of the bisphosphonates, be sure to let your dentist know, especially before any dental procedures.
via MedPage Today, January 2009
November 13th, 2008 by Nina Thompson, ARNP
Infants’ Mylicon Gas Relief Dye Free Non-Staining Drops have been recalled due to the potential for contamination with metal fragments generated during the manufacturing process. The simethicone drops are sold in one-ounce plastic bottles with one of two lot numbers: SMF007 and SMF008. The lot numbers are located either on the bottom of the box containing the product or on the lower left side of the label on the bottle.
The bottles were distributed throughout the U.S. after Oct. 5. The recall does not affect any Original Infants’ Mylicon Gas Relief products (1/2 oz- or 1-oz size) or the half-oz size of Infants’ Mylicon Gas Relief Dye Free Non-Staining Drops.
The manufacturer, Johnson & Johnson Merck Consumer Pharmaceuticals, has said the potential for adverse events is low, and those that do occur are expected to be temporary and resolve without complication. Parents who have given the product to their infant should immediately stop using the product and are advised to contact their health care provider immediately. The company can be contacted by calling 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com.
via FDA, November 7, 2008