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Putting zinc up your nose doesn’t seem like a good idea. It isn’t, says the Food and Drug Administration. June 16, 2009, the agency told consumers to cease using and pitch three zinc-containing Zicam intranasal products.

Since the debut of Zicam Cold Remedy Nasal Gel in 1999, the FDA has received more than 130 complaints of anosmia (loss of sense of smell) associated with the following:

~Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
~Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
~Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
**Kids size has been discontinued

Some users lost their sense of smell immediately while others said it occurred after repeated applications of the zinc-contained product. Regardless, anosmia is an alarming, impairing condition that could result in permanent loss of not only smell, but taste (ageusia) also.

Not being able to fully appreciate a gourmet meal is unfortunate but the inability to smell smoke or a gas leak could prove deadly. The FDA is especially concerned with children who might not communicate their loss of smell to adults, thus possibly putting themselves in a perilous situation.

In the culinary arena, smell and taste are imperative. Imagine your favorite restaurant’s chef lacking these abilities. The ramification of spoiled food is disgusting and dangerous.

Zicam’s zinc-containing oral cold remedies are not included in the FDA warning. Apparently, anosmia seems to be solely related to the intranasal types, which can cause burning or stinging in the nose. There are also a host of other Zicam brands—about 17—that are not involved at this time.

Assessing blame is a favorite American pastime. Matrixx Initiatives, makers of the three affected products, said these items reduced the duration and severity of colds although this has not been proven. Most similar companies boast the same claims.

The FDA sent Matrixx a warning letter advising them that these products cannot be marketed without FDA approval and that they do not include adequate warnings about risk of losing one’s sense of smell.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the agency’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance.

Interestingly, the FDA was previously aware of scientific research linking the connection between intranasal zinc and anosmia. Should they have issued a consumer warning sooner? Perhaps.

But the public also has an obligation not to assume everything they hear, see, or read is true. Colds are a miserable nuisance but they run their course without ingesting a pill or putting a zinc product up the nose.

Report adverse side effects related to Zicam to the FDA’s MedWatch Adverse Event Reporting program online, fax (800-FDA-0178) or phone (800-FDA-1088).

There’s a lot of tummy rumbling out there. More than 2 million people depend on Reglan and other metoclopramide drugs to treat their gastrointestinal disorders such as colitis, heartburn, and acid reflux disease.
These medications are supposed to boost stomach muscle movement to aid digestion. Specifically, they increase muscle contractions in the upper digestive tract, which accelerates the rate that the stomach empties into the intestines.
Reglan is also prescribed for diabetics who have slow gastric emptying (diabetic gastroparesis), which can cause heartburn, nausea, vomiting, appetite loss, and bloating after eating.
But yesterday the Food and Drug Administration (FDA) issued a Reglan alert linking the drug to tardive dyskinesia, a serious neurological disorder with symptoms often irreversible and untreatable.
A Black Box Warning on the drug’s label was already in effect cautioning of movement disorders associated with metoclopramide use—however, it suggests this rarely happens. Not so, according to two studies which determined tardive dyskinesia appeared in almost 30 percent of long time users. Some of the characteristic side effects are:
~Blinking or rapid eye movement
~Lip-smacking
~Pursing or puckering of the lips
~Sticking out the tongue
~Grimacing
~Impaired finger motion
~Involuntary repetitive movements of extremities

Although many heartburn and acid reflux sufferers feel better after taking these medications, Reglan and its ilk were never meant for long-term use. Three months is the recommended dosage time frame and only after trying other therapies without experiencing relief (FDA approval said 4 to 12 weeks use). Unfortunately but not surprisingly, about a third of Reglan patients are hooked for a year or longer.
Obviously, the risks and side effects increase with time but age and sex seem to matter since older women are especially vulnerable.
Another critical condition is also connected to Reglan. Neuroleptic Malignant Syndrome (NMS) is usually affiliated with antipsychotic medications and often appears within the first few weeks of drug treatment. Some symptoms include sweating, high fever, erratic blood pressure, stupor, stiff muscles, confusion, anxiety, depression and thoughts of suicide. Immediate medical attention is imperative for this neurological emergency.
It is alarming that numerous potent drugs with innumerable perilous side effects are widely approved by the FDA, slickly marketed by pharmaceutical companies, prescribed by blasé doctors, and demanded by an over-medicated society. How did we ever survive before?
Instead of Reglan, perhaps those plagued with heartburn, acid reflux, and other uncomfortable gastro conditions should consider trying ginger ale, baking soda dissolved in water, peppermint tea, or just maybe…. improving their diet.
If healthier options fail, the patient still needs to assume responsibility for what is put in one’s body. Be aware of ALL potential side effects, ask questions, and ascertain if this drug could cause more harm than good.

Reports of critical liver problems and one death have prompted the FDA to pull 14 popular Hydroxycut items from the shelves. Government health officials urged body builders and dieters to immediately stop ingesting their favorite product and return it to the place of purchase.

Touted as derived from natural ingredients, the Canadian made supplement is favored by those hoping to shed pounds and body builders desiring improved muscle tone and definition. Readily available in grocery stores and pharmacies, at least nine million packages were sold in the U.S. last year, according to the FDA.

Dr. Linda Katz of the agency’s food and nutrition division said they have received 23 reports of serious liver problems including jaundice (yellowing of the skin or whites of the eyes), elevated liver enzymes, liver failure, a transplant, and one patient waitlisted for a new liver. Also, a 19-year-old boy died in 2007 but his death was not reported to the FDA until March of this year.

Other documented health concerns include cardiovascular disorders, seizures, and rhabdomyolysis, which is a type of muscle damage. The condition often precedes other grave health issues such as kidney failure.

Surprisingly, the FDA says the liver injuries did not appear to be the result of overdose but then…. their information came from the involved patients. All claimed they adhered to the recommended dosage on the Hydroxycut bottle.

The agency adamantly urged users to seek medical attention if they experience any of the following conditions: jaundice, nausea, vomiting, light-colored stools, brown urine, excessive fatigue, weakness, itching, loss of appetite, and abdominal pain.

Although Hydroxycut Cleanse and Hoodia products are not affected, Iovate Health Sciences Inc., of Oakville, Ontario, has agreed to recall the following:

~Hydroxycut Regular Rapid Release Caplets
~Hydroxycut Caffeine-Free Rapid Release Caplets
~Hydroxycut Hardcore Liquid Caplets
~Hydroxycut Max Liquid Caplets
~Hydroxycut Regular Drink Packets
~Hydroxycut Hardcore Drink Packets (Ignition Stix)
~Hydroxycut Caffeine-Free Drink Packets
~Hydroxycut Max Drink Packets
~Hydroxycut Liquid Shots
~Hydroxycut Hardcore RTD (Ready-to-Drink)
~Hydroxycut Max Aqua Shed
~Hydroxycut Carb Control
~Hydroxycut Natural
~Hydroxycut 24

The company stated on their May 1 website that the recall was voluntary. “While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products,” the statement said.

As always, this is a situation of consumer beware. Our government does not regulate dietary supplements as rigidly as medications. Appalling, manufacturers need not prove to the FDA that their products are effective or safe before greedily tossing them out to a quick-fix public. Regulators claim to monitor aftermarket reports for indications of potential problems and recently, companies have been under pressure and tightened requirements to alert the FDA when this occurs.

Dr.Katz lamented, “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow.” Also, the agency heavily relies on voluntary information to detect a red flag situation. Many times, cases are never reported.

Based on available information, health officials said they cannot determine which Hydroxycut ingredients or proprietary blends are the toxic culprits, probably because the product formulation has changed several times. But last month a medical journal report speculated that one ingredient…a tropical fruit derivative, hydroxycitric acid, could possibly cause liver damage.

Once again, the FDA is stumped. They said they could not ascertain which other factors, such as length of use, dosage, combining with other supplements or drugs, or one’s health condition could affect the risk of using Hydroxycut.

Healthy diet and exercise anyone?