Monthly Archives: February 2013

Beware Fraudulent Flu Products

In the past week, FDA has sent an additional nine warning letters to firms marketing fraudulent flu products, including flufraudredflagan online firm marketing an “alternative to the flu shot,” a firm selling an oral spray online and in major retail stores, and three firms marketing dietary supplements online. (The latter three firms’ letters are co-signed by the Federal Trade Commission, which regulates the advertising of many consumer products.)

The remaining four warning letters were issued to online firms selling what they claim to be generic and other unapproved versions of oseltamivir phosphate (the active ingredient in Tamiflu). Tamiflu is an FDA-approved brand-name drug; no generic is approved in the U.S.

As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.

These scammers sell their products with claims to prevent, treat or cure the flu, even though they have not been tested and the Food and Drug Administration (FDA) has not approved them.

FDA warns consumers to steer clear of fraudulent flu products, which can be found online and in retail stores and may include products marketed as dietary supplements or conventional foods, drugs, nasal sprays and devices.

“As any health threat emerges, fraudulent products appear almost overnight,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Right now, so-called ‘alternatives’ to the flu vaccine are big with scammers.”

“These unproven products give consumers a false sense of security,” says Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality. “There is no need to buy a product that claims to be an alternative to the vaccine. Flu vaccine is still available and it’s not too late to get vaccinated.”

Flu Fraud Red Flags!

These flu claims on an unapproved product indicate that it may be fraudulent:

  • reduces severity and length of flu
  • boosts your immunity naturally without a flu shot
  • safe and effective alternative to flu vaccine
  • prevents catching the flu
  • effective treatment for flu
  • faster recovery from flu
  • supports your body’s natural immune defenses to fight off flu

The best way to prevent the flu is by getting vaccinated every year, and the Centers for Disease Control and Prevention (CDC) recommends the vaccine for adults and children over six months of age. To find a list of clinics, supermarkets, pharmacies and other vaccine providers in your neighborhood, visit www.flu.gov, click on “Flu Vaccine Finder” and enter your zip code.

If you get the flu, two FDA-approved antiviral drugs—Tamiflu (oseltamivir) and Relenza (zanamivir)—are treatment options recommended by CDC. These prescription drugs can help fight the virus in your body and shorten the time you’re sick. They can also be used to help prevent the flu.

Types of Fraudulent Flu Products

There are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.

NOTE: Never give aspirin or aspirin products to children under that age of 19 for flu or viral No Aspirin Products for Children!infections!

Unapproved drugs (which sometimes are marketed as dietary supplements), conventional foods (such as herbal teas) or devices (such as air filters and light therapies) are fraudulent if they make flu prevention, treatment or cure claims, says Coody, “because they haven’t been evaluated by FDA for these uses.”

On Jan. 25, 2013, FDA and the Federal Trade Commission jointly sent a warning letter to the company that markets “GermBullet,” a nasal inhaler that makes flu prevention and treatment claims. The firm is required to remove the language in its labeling and advertising that violates federal law.

“If the company continues to sell the product without removing the deceptive and illegal language, the firm may be subject to enforcement action, which could include seizure of the products or other legal sanctions,” says FDA Regulatory Counsel Brad Pace, J.D., of FDA’s Health Fraud and Consumer Outreach Branch.

Fraudulent Online Pharmacies

Online pharmacies present an opportunity for Internet scammers to take advantage of unsuspecting consumers. Legitimate online pharmacies do exist, but so do many websites that look like professional and legitimate pharmacies but are actually fraudulent and illegal.

These websites may be selling unapproved antiviral drugs. “Beware of websites that sell generic Tamiflu or Relenza,” says FDA pharmacist Connie Jung, R.Ph., Ph.D., of FDA’s Office of Drug Security, Integrity and Recalls. “Currently there are no FDA-approved generics available for these drugs on the U.S. market.”

“With unapproved products, you really don’t know what you’re getting and can’t be sure of the quality,” adds Jung. “The products could be counterfeit, contaminated, or have the wrong active ingredient or no active ingredient. You could experience a bad reaction, or not receive the drug you need to get better.”

Jung also warns consumers not to be tempted by an online seller that offers much lower prices than typically charged for prescription drugs by your local pharmacy. “Deep discounts on price are a good indicator of a fraudulent, illegal online pharmacy. You should avoid these online sellers because you might get products that are harmful to your health.”

FDA encourages consumers to buy prescription drugs only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care provider and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.

Health fraud is pervasive and it’s not always easy to spot a fraudulent product, says Coody. “If you’re tempted to buy an unproven or little known treatment, especially if it’s sold on the Internet, check with your health care provider first.”

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Product Brand Names for Aspirin

aspirintabletAlthough aspirin is an old drug, we often mistakenly take its safety for granted; it can be a dangerous drug, especially for children.

You might be surprised at the number of medications that contain aspirin (salicylates).  To assist you in recognizing some of the medications that contain aspirin, we have provided some lists below.  These are all basic guides, and you must always read the labels.   And, of course, these products are not to be used with children under the age of 19! 

As with most medications, whether they be prescription or over the counter, you want to be careful that you are not ‘double-dosing’  because the recommended dosages are already just below the toxic level to human beings.

Aspirin Brand Names:

  • Acuprin®
  • Anacin® Aspirin Regimen
  • Ascriptin®
  • Aspergum®
  • Aspidrox®medicine_cabinet
  • Aspir-Mox®
  • Aspirtab®
  • Aspir-trin®
  • Bayer® Aspirin
  • Bufferin®
  • Buffex®
  • Easprin®
  • Ecotrin®
  • Empirin®
  • Entaprin®
  • Entercote®
  • Fasprin®
  • Genacote®
  • Gennin-FC®
  • Genprin®
  • Halfprin®
  • Magnaprin®
  • Miniprin®
  • Minitabs®
  • Ridiprin®
  • Sloprin®
  • Uni-Buff®
  • Uni-Tren®
  • Valomag®
  • Zorprin®

Brand names of combination products

  • Alka-Seltzer® (containing Aspirin, Citric Acid, Sodium Bicarbonate)
  • Alka-Seltzer® Extra Strength (containing Aspirin, Citric Acid, Sodium Bicarbonate)
  • Alka-Seltzer® Morning Relief (containing Aspirin, Caffeine)
  • Alka-Seltzer® Plus Flu (containing Aspirin, Chlorpheniramine, Dextromethorphan)
  • Alka-Seltzer® PM (containing Aspirin, Diphenhydramine)
  • Alor® (containing Aspirin, Hydrocodone)
  • Anacin® (containing Aspirin, Caffeine)
  • Anacin® Advanced Headache Formula (containing Acetaminophen, Aspirin, Caffeine)
  • Aspircaf® (containing Aspirin, Caffeine)
  • Axotal® (containing Aspirin, Butalbital)
  • Azdone® (containing Aspirin, Hydrocodone)
  • Bayer® Aspirin Plus Calcium (containing Aspirin, Calcium Carbonate)
  • Bayer® Aspirin PM (containing Aspirin, Diphenhydramine)
  • Bayer® Back and Body Pain (containing Aspirin, Caffeine)
  • BC Headache (containing Aspirin, Caffeine, Salicylamide)
  • BC Powder (containing Aspirin, Caffeine, Salicylamide)
  • Damason-P® (containing Aspirin, Hydrocodone)
  • Emagrin® (containing Aspirin, Caffeine, Salicylamide)
  • Endodan® (containing Aspirin, Oxycodone)
  • Equagesic® (containing Aspirin, Meprobamate)
  • Excedrin® (containing Acetaminophen, Aspirin, Caffeine)
  • Excedrin® Back & Body (containing Acetaminophen, Aspirin)
  • Goody’s® Body Pain (containing Acetaminophen, Aspirin)
  • Levacet® (containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
  • Lortab® ASA (containing Aspirin, Hydrocodone)
  • Micrainin® (containing Aspirin, Meprobamate)
  • Momentum® (containing Aspirin, Phenyltoloxamine)
  • Norgesic® (containing Aspirin, Caffeine, Orphenadrine)
  • Orphengesic® (containing Aspirin, Caffeine, Orphenadrine)
  • Panasal® (containing Aspirin, Hydrocodone)
  • Percodan® (containing Aspirin, Oxycodone)
  • Robaxisal® (containing Aspirin, Methocarbamol)
  • Roxiprin® (containing Aspirin, Oxycodone)
  • Saleto® (containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
  • Soma® Compound (containing Aspirin, Carisoprodol)
  • Soma® Compound with Codeine (containing Aspirin, Carisoprodol, Codeine)
  • Supac® (containing Acetaminophen, Aspirin, Caffeine)
  • Synalgos-DC® (containing Aspirin, Caffeine, Dihydrocodeine)
  • Talwin® Compound (containing Aspirin, Pentazocine)
  • Vanquish® (containing Acetaminophen, Aspirin, Caffeine)
  • TIP: It is important to keep a written list of all of any prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements, because many of these contain salicylates, too. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Other Over The Counter Medications that Contain Aspirin:

  • Kaopectate
  • Maalox
  • PamprinNo Aspirin Products for Children!
  • Pepto-Bismol
  • Vanquish
  • Alka-Seltzer
  • Doan’s

For lists of aspirin containing products, both prescription and over the counter, go to the Reye’s Syndrome website by clicking here.

Symptoms of aspirin overdose may include:

  • burning pain in the throat or stomach
  • vomiting
  • decreased urination
  • fever
  • restlessness
  • irritability
  • talking a lot and saying things that do not make sense
  • fear or nervousness
  • dizziness
  • double vision
  • uncontrollable shaking of a part of the body
  • confusion
  • abnormally excited mood
  • hallucination (seeing things or hearing voices that are not there)
  • seizures
  • drowsiness
  • loss of consciousness for a period of time
Symptoms for Reye’s Syndrome include:
Stage I Symptoms Stage II Symptoms Stage III Symptoms Stage IV Symptoms
Persistent or continuous vomiting
Signs of brain dysfunction:
Listlessness
Loss of pep and energy
Drowsiness
Personality changes:
Irritability
Aggressive behavior
Disorientation:
Confusion
Irrational behavior
Combative
Delirium
Convulsions
Coma

NOTE: The symptoms of Reye’s Syndrome in infants do not follow a typical pattern. For example, vomiting may be replaced with diarrhea and infants may display irregular breathing.

Suspect Reye’s in an Infant with:

  • * Diarrhea, but not necessarily vomiting
    * Respiratory disturbances such as hyperventilation or apneic episodes, seizures and hypoglycemia are common
    * Elevated SGOT-SGPT (SAT-ACT) [usually 200 or more units] in the absence of jaundice
Reye’s Syndrome should be suspected in a person if this pattern of symptoms appear during, or most commonly, after a viral illness. Not all of the symptoms have to occur, nor do they have to be displayed in this order. Fever is not usually present. Many diseases have symptoms in common. Physicians and medical staff in emergency rooms who have not had experience in treating Reye’s Syndrome may misdiagnose the disease.
The NRSF has compiled an enormous amount of aspirin information, including non-aspirin products, and aspirin products, in lists in an Android app available in the google play store:  Aspirin Sense and Sensitivity.

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Shingles; The Varicella Zoster Virus

Shinglesshingles

Almost 1 out of every 3 people in the United States will develop shingles, also known as zoster or herpes zoster. There are an estimated 1 million cases each year in the United States. Anyone who has had the chickenpox may develop shingles; even children can get shingles. The risk of the disease increases as a person gets older. About half of all cases occur among men and women 60 years old or older.  There are many reports, however, of shingles showing up in children and in the 20 year old to 40 year old range.

People who have medical conditions that keep their immune systems from working properly, such as certain cancers, including leukemia and lymphoma, and human immunodeficiency virus (HIV), and people who receive immunosuppressive drugs, such as steroids and drugs given after organ transplantation, are also at greater risk of getting shingles.

People who develop shingles typically have only one episode in their lifetime. In some cases, however, a person can have a second or even a third episode.

Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. After a person recovers from chickenpox, the virus stays in the body in a dormant (inactive) state. For reasons that are not fully known, the virus can reactivate years later, causing shingles. Herpes zoster is not caused by the same virus that causes genital herpes, a sexually transmitted disease.

Shingles usually starts as a painful rash on one side of the face or body. The rash forms blisters that typically scab over in 7–10 days and clears up within 2–4 weeks.

Before the rash develops, there is often pain, itching, or tingling in the area where the rash will develop. This may happen anywhere from 1 to 5 days before the rash appears.

Most commonly, the rash occurs in a single stripe around either the left or the right side of the body. In other cases, the rash occurs on one side of the face. In rare cases (usually among people with weakened immune systems), the rash may be more widespread and look similar to a chickenpox rash. Shingles can affect the eye and cause loss of vision.

  • Other symptoms of shingles can include:
  • Fever
  • Headache
  • Chills
  • Upset stomach

Shingles cannot be passed from one person to another. However, the virus that causes shingles, the varicella zoster virus, can be spread from a person with active shingles to a person who has never had chickenpox. In such cases, the person exposed to the virus might develop chickenpox, but they would not develop shingles.

The virus is spread through direct contact with fluid from the rash blisters, not through sneezing, coughing or casual contact.

A person with shingles can spread the virus when the rash is in the blister-phase. A person is not infectious before blisters appear. Once the rash has developed crusts, the person is no longer contagious.

Shingles is less contagious than chickenpox and the risk of a person with shingles spreading the virus is low if the rash is covered.

  • If you have shingles:
  • Keep the rash covered.
  • Do not touch or scratch the rash.
  • Wash your hands often to prevent the spread of varicella zoster virus.
  • Until your rash has developed crusts, avoid contact with pregnant women who have never had chickenpox or the varicella vaccine; premature or low birth weight infants; and immunocompromised persons (such as persons receiving immunosuppressive medications or undergoing chemotherapy, organ transplant recipients, and people with HIV infection).

The most common complication of shingles is a condition called postherpetic neuralgia (PHN). People with PHN have severe pain in the areas where they had the shingles rash, even after the rash clears up.

The pain from PHN may be severe and debilitating, but it usually resolves in a few weeks or months in most patients. PHN can, however, persists for many years in some persons.

As people get older, they are more likely to develop PHN, and the pain is more likely to be severe. PHN occurs rarely among people under 40 years of age but can occur in up to half (and possibly more) of untreated people who are 60 years of age and older.

Shingles may lead to serious complications involving the eye. Very rarely, shingles can also lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis) or death.

Several antiviral medicines—acyclovir, valacyclovir, and famciclovir—are available to treat shingles. These medicines will help shorten the length and severity of the illness. But to be effective, they must be started as soon as possible after the rash appears. Thus, people who have or think they might have shingles should call their healthcare provider as soon as possible to discuss treatment options.

Analgesics (pain medicine) may help relieve the pain caused by shingles. Wet compresses, calamine lotion, and colloidal oatmeal baths may help relieve some of the itching.

The only way to reduce the risk of developing shingles and the long-term pain that can follow shingles is to get vaccinated. A vaccine for shingles is licensed for persons aged 60 years and older.

The shingles vaccine (Zostavax®) was recommended by the Advisory Committee on Immunization Practices (ACIP) in 2006 to reduce the risk of shingles and its associated pain in people age 60 years and older.

Your risk for developing shingles increases as you age. The Shingles Prevention Study involved individuals age 60 years and older and found the shingles vaccine significantly reduced disease in this age group. The vaccine is currently recommended for persons 60 years of age and older. Even people who have had shingles can receive the vaccine to help prevent future occurrences of the disease.

Shingles vaccine is available in pharmacies and doctor’s offices. Talk with your healthcare professional if you have questions about shingles vaccine.

At this time, CDC does not have a recommendation for routine use of shingles vaccine in persons 50 through 59 years old. However, the vaccine is approved by FDA for people in this age group.

Some people should NOT get shingles vaccine.

  • A person who has ever had a life-threatening or severe allergic reaction to gelatin, the antibiotic neomycin, or any other component of shingles vaccine. Tell your doctor if you have any severe allergies.
  • A person who has a weakened immune system because of HIV/AIDS or another disease that affects the immune system, treatment with drugs that affect the immune system, such as steroids, cancer treatment such as radiation or chemotherapy, cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma.
  • Women who are or might be pregnant

Some people who get the shingles vaccine will develop a chickenpox-like rash near the place where they were vaccinated.  As a precaution, this rash should be covered until it disappears.

The shingles vaccine does not contain thimerosal (a preservative containing mercury).

What are the risks from shingles vaccine?

A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. However, the risk of a vaccine causing serious harm, or death, is extremely small.

No serious problems have been identified with shingles vaccine.

Mild Problems:

Redness, soreness, swelling, or itching at the site of the injection (about 1 person in 3).
Headache (about 1 person in 70).

Like all vaccines, shingles vaccine is being closely monitored for unusual or severe problems.

What about taking aspirin during a Shingles episode? We don’t know yet, but we are monitoring this closely and will keep you updated.  Never give a child aspirin during a shingles episode, as shingles is a dormant chickenpox virus!

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Joshua’s Story

joshuaMy son, Joshua, a sophomore at Hampshire College in Amherst, Massachusetts died from the complications of Reye’s Syndrome in 1994… he was 19 years old.  At the time his illness began, he was a healthy six-foot college sophomore, happy with his life and the college of his dreams.  He was growing into a wonderful young man and excelled in his course studies at the college he loved.

He called me one snowy day to say he was not feeling well. He asked me what he should do. I advised him to go to Student Health and call me right after his appointment. The doctor said he had the flu. Based on the symptoms he described, I told him he should come home and we would see our family doctor. It seemed to me he had Mono. He came home and saw our family doctor who confirmed that he did indeed have Mono.

The treatment was simple…get plenty of rest and drink lots of liquids. The problem was that as the days progressed, he continued to get sicker. We went back to see the doctor every day for several days. Then he was admitted to the hospital, discharged and admitted again. Still he was no better.

He was admitted once again and this time he was critical. Our doctor either thought there was nothing to worry about or he didn’t know what he was dealing with. Josh had test after test and still there were no answers.

Finally, Joshua was transferred to another hospital… the last time Joshua spoke was in the ambulance. When we arrived at the hospital we were met by a team of doctors and while taking him to intensive care they requested a signed consent form for a liver transplant. Every possible test was done, and finally the diagnosis of Reye’s Syndrome was made.

Doctors put Joshua into a drug induced coma, and on life support. He continued to get worse and on March 4th, he suffered brain death. On March 5th we disconnected life support and he stopped breathing immediately. His death occurred 2 weeks after he was diagnosed with the flu and one week after being admitted to the medical center.

Joshua’s Mom states;

“I strongly believe education is the best prevention. I know I was aware of not giving aspirin to children with viral infection, but I didn’t consider the over the counter medications we all take may contain aspirin.

“Since Joshua’s death, the hospital has instituted a protocol for Reye’s Syndrome because they did not know what they were dealing with in Joshua’s illness.

“There were a combination of issues that played a role in Joshua’s death from Reye’s Syndrome. Our trusted doctor did not take Joshua’s illness seriously, and the other doctors who treated Joshua ran tests but didn’t know what they were dealing with.  When Joshua was admitted to the hospital for the last time our physician went to a medical convention out of state. He called me when he returned to ask about my son. It was too late, Joshua had died.

“It is my strongest belief that parents, doctors and hospitals need to be educated about Reye’s Syndrome. I am finally able to write about this 13 years after his death and would like to offer my assistance in helping to accomplish this important goal.”

Let Joshua’s Story be a learning experience, one that keeps our young people alive and safe from the threat of Reye’s Syndrome. So tell them Why…. tell them about Aspirin and about the products that contain aspirin (salicylates). Teach them to read the labels.

Tell them about Reye’s…. they can pass the word to their friends who offer them an aspirin, alka-seltzer, or pamprin, pepto-bismol or muscle creams that contain salicylates.

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