Zicam Products Removed from Store Shelves

From Geriatric Pharmacy Intern Angela M Antuna, PharmD(c) Palm Beach Atlantic University Lloyd L. Gregory School of Pharmacy

Why Zicam nasal products are not safe to use
The FDA has recently issued an alert on Zicam nasal gels and swabs due to the risk of anosmia or loss of smell. Reports have shown that people have experienced loss of smell with just the first application. In addition, the loss of smell may be more than temporary. Some reports say that it may be permanent. Others have also reported loss of taste too. The sense of smell and taste work closely together to give food its distinct taste. In some cases the sense of smell can save lives. For example, it is important to be able to smell smoke in case of a fire.
Zicam products are frequently sold at retail drug stores for early signs of the common cold. These products are homeopathic or natural products given in small amounts. Many natural products are not thoroughly tested by the FDA for safety and efficacy. Zinc gluconate is the chief ingredient found in Zicam. Some believe the intranasal application of zinc gluconate may be killing the receptors responsible for the sense of smell. The company strongly believes in the product and that the loss of smell may be due to the common cold itself. The FDA is now thoroughly investigating if the loss of smell is directly related to its use.
The company has willingly taken these products off the market and is asking consumers to throw away any remaining. However, for a refund you could simply go online to www.zicam.com and fill out the form provided. The company states, “The other 17 Zicam-branded products (including our oral Cold Remedy, cough, sinus, extreme congestion and allergy products) are all safe and effective and will remain on retailer shelves.”

FDA investigating several drugs for possible safety concerns

From Geriatric Pharmacy Intern, Allyson Torres, PharmD(c)
Nova Southeastern University College of Pharmacy

On Thursday, May 28, 2009 the FDA released its quarterly list of drugs that it is in the early stages of reviewing for potential safety concerns. The list contained about 2 dozen drugs, including the overactive bladder drug Detrol® (Pfizer) which is under review for reports of Steven-Johnson syndrome, a serious skin reaction, the smoking cessation drug Chantix® (Pfizer), which is under review for possible risk of accidental injury, vision impairment and other issues, sleep disorder drugs Nuvigil® and Provigil® (Cephalon) which are under review for serious skin reactions and the weight loss drugs Alli® (GlaxoSmithKline) and Xenical® (Roche Inc) for possible induction of liver toxicity.
Alli and Xenical (orlistat) are thought to actually be of value in TREATING certain liver problems, such as non-alcoholic fatty liver disease, in obese patients. Some research has shown that orlistat reduces fatty infiltration, improves inflammatory activity, improves hepatic fibrosis, lowers amino transferase levels, total cholesterol, triglyceride and LDL levels and reduces insulin resistance. However, other research shows no significant improvement, and recently there have been reports of liver toxicity in patients taking orlistat that are suspected to be related to its usage. As reported in the Journal of Hepatology by Montero et al in 2001, one patient developed sub-acute liver failure while being treated with orlistat as the only drug and had to receive a liver transplant. The FDA is clear that it has not yet determined causation in terms of the drugs under review and the reported adverse effects. It will be interesting to see if further research proves whether orlistat can either cause or help treat liver problems- or both!

Age-related medication use considerations

Medications are used with the intent to improve quality of life. Older adults are at an increased risk for medication-related problems. Drug therapy may cause more harm than good if an improper medication is used or therapy is not monitored. There are many factors that increase the likelihood of a medication-related problem in the older patient.
As we get older, our body metabolizes and eliminates drugs less effectively; this is a result of primarily liver and kidney function decline. If doses aren’t adjusted for these changes it can lead to adverse drug events, complications and even mortality. Medication response is also enhanced in the elderly; they are more sensitive to effects of the drug, both therapeutic effects and side effects. Side effects like dizziness, sedation and fatigue are more commonly experienced and pose danger to the geriatric patient. As a results of all this, there are certain medications that should be avoided or used cautiously with monitoring parameters.
Older patients frequently have multiple chronic illnesses (high blood pressure, diabetes, arthritis, GERD, etc.). Medications that may work to help once condition may adversely affect another. Not only do we need to worry about all the illnesses one may have, we also need to consider what other medications they are taking. Adverse drug advents due to multiple drug interactions are prevalent because most geriatric patients take more than one medication.
It is important that all these aspects are considered when prescribing or beginning treatment in the geriatric patient to prevent medication-related problems.

Brian Wolstenholme, PharmD, CGP, FASCP
www.medisort.net