Archive for the 'Medication' Category

Liquid Infant’s and Children’s Over-the-Counter Products Recalled

Liquid medicine for infants and children are included in the recallAmid a number of FDA concerns over quality control, McNeil Consumer Products has voluntarily recalled over 40 infant’s and children’s over-the-counter products.

Products included in the recall are Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infants’ Drops, Children’s Motrin Suspensions, Children’s Motrin Cold Suspensions, Children’s Zyrtec liquids in bottles, and Children’s Benadryl Allergy liquids in bottles.

The FDA has recently discovered that some of the “products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”

The agency says that there have been no reports of adverse side effects and the potential for serious medical evens is remote.  

Experts urge parents to immediately discontinue use and throw out any of these products that they may currently have in their medicine cabinets.

In an article by MedPage today, “McNeil recalled several varieties of Children’s Tylenol last September because of possible contamination with a Gram-negative bacteria, Burkholderia cepacia, and earlier this year the manufacturer recalled a wide variety of products, including Children’s Tylenol, because of consumer complaints of an unusual, moldy, musty, or mildew-like odor.”

SOURCE: “FDA provides consumer advice following recall of products for infants and children”, FDA, May 1, 2010

SOURCE: “Children’s Cold, Pain, and Allergy Medicines Recalled”, MedPage Today, May 1, 2010 
 

It Must be Safe if it’s on the Store Shelf, Right?

Weight loss pills

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

Generics Versus Brand Names

The FDA allows a variance of 20% when it comes to generic medicationsBrand 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

Acetaminophen (Tylenol) Toxicity Is Leading Cause of Acute Liver Failure

The digestive system with the liver highlightedYour 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

 

 

Large Recall of Commonly-Prescribed Generic Medicine

Generic prescription drugsMore 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

Many OTC weight-loss pills are from China and dangerous

PillsMore 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:

Mylicon drops for infants recalled

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

Six facts everyone should know about Tylenol

Tylenol, cold medicine, and wine are a toxic combinationAcetaminophen (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. When taken as directed, it’s thought to be safe, but it’s very important that the following facts are well known:

  1. Acetaminophen 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.
  2. 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.
  3. Overdoses also occur simply because people underestimate or are unaware of acetaminophen’s toxicity. Many cold remedies already contain acetaminophen (Tylenol), and overdoses can easily occur by taking acetaminophen in addition to a cold remedy, or two cold remedies which both contain acetaminophen. It’s very important to read the label of all over-the counter products before taking them.  Do not combine products which both contain acetaminophen.
  4. Parents can make a variety of mistakes in the amount of acetaminophen they give their children. For one, a parent may be unsatisfied with the results of the recommended dosage of acetaminophen, and decide more will be better. Another common mistake occurs when a parent may mistakenly give adult tablets to a child, instead of the children’s formulation. Also, even the children’s versions of acetaminophen come in many different formulations, and the dosage varies for each one. For example, the infant drop formulation is three times as concentrated as the elixir or syrup typically given to toddlers. It’s easy to see how a busy parent might assume that both liquids contain the same amount of medicine. But substituting infant drops for syrup could result in a dose of acetaminophen three times what it should be.
  5. Acetaminophen is frequently the drug of choice for adolescent suicide attempts. There is an antidote but it must be administered within eight to 10 hours after an overdose has been ingested.
  6. Toxic levels of acetaminophen can result in severe liver damage or liver failure. Your liver is a vital organ–you can’t live without it.

As long as acetaminophen is given to children at recommended doses, there is virtually no risk of liver toxicity, according to a recent large study from Rocky Mounting Poison and Drug Center in Denver.  But it cannot be stressed enough that’s it’s essential to read the label of all over-the-counter products before taking them or giving them to your child.

via “Over-the-Counter Pain Relief” from Bay Area Medical Information
via “AASLD: Acetaminophen Dosed Properly Poses Minimal Liver Risk to Children” from MedPage Today, November 3, 2008

Aspirin is a Good Drug for Heart Health in Certain People, But Often Not Used

Although it’s well known that taking aspirin regularly can lower a person’s risk of heart disease, few Americans take aspirin regularly for heart health.

A new study finds that use of aspirin is underutilized in the prevention of a first or second heart attack or stroke, even among adults at increased risk for such events. There are many people that should be on aspirin, yet the researchers found that large numbers of people at relatively high risk for heart attack and stroke were not taking it regularly.

Source: American Journal of Preventive Medicine, May 2007

Daily Long-Term Use of Adult-strength Aspirin May Reduce Cancer Risk by About 15%

According to the American Cancer Society, “A large analysis by American Cancer Society researchers suggests that daily long-term use of adult-strength aspirin may reduce cancer risk by about 15% in both men and women. Daily aspirin use is often recommended for preventing heart disease and stroke in people at high risk of these problems. The aspirin-cancer link has been widely studied, but researchers have not been able to come to any firm conclusion about whether it is useful for cancer prevention. In animals, aspirin inhibits the development of many types of cancer, including colorectal, breast, prostate, lung, bladder, and skin. Studies on people have been harder to interpret. Some have shown that aspirin can reduce the risk of colorectal cancer and polyps (growths that can lead to cancer). Others have linked aspirin use to lower risk of stomach and esophageal cancer, as well as breast, prostate, and lung cancer. Still others have found no effect on cancer at all.”

Source: American Cancer Society, April 2007