THIS JUST IN...

FDA green lights generic Lamisil
The U.S. Food and Drug Administration (FDA) has approved the first generic versions of prescription terbinafine hydrochloride (Lamisil) tablets (250 mg) to treat fungal infection of the nail. Applications from multiple generic drug manufacturers were approved; the patent for Lamisil expired on June 30, 2007. Lamisil tablets are the 57th highest selling brand-name prescription drug in the United States, according to the online trade magazine, Drug Topics.

The FDA also approved a generic version of over-the-counter terbinafine hydrochloride cream (1%) to treat athlete’s foot.

FDA warns consumers: Buying drugs on the Internet is risky business
About 45% of imported drugs are available in the United States as generic drugs, according to the U.S. Food and Drug Administration (FDA) after examination of foreign mail shipments. This means that consumers who are trying to save money on prescription drugs don’t need to take chances by buying these drugs from foreign Internet sites.

Recent examination of a sample of drugs shipped to U.S. consumers also found several high-risk drugs that are dangerous to the consumer if used without a health care provider’s supervision.

The FDA raises concerns that consumers are likely buying foreign drugs to avoid getting a prescription from their health care provider. Many foreign Web sites selling drugs to consumers don’t require a prescription. The FDA urges consumers to obtain a prescription before using prescription drugs.

Drugs purchased from unregulated Internet vendors may:

• require careful dosing and monitoring
• carry risks that require initial screening
• have clinically significant drug-drug interactions
• not have adequate labeling for safe use
• be inappropriately packaged
• have been withdrawn from the U.S. market for safety or efficacy reasons.

To view the consumer article, “The possible dangers of buying medicine online,” visit http://www.fda.gov/consumer/features/drugsonline0707.html.

ISMP: Transdermal patches pose safety risk
The Institute for Safe Medication Practices (ISMP) warns about a potential overdose problem when delivering medication via transdermal patch, based on several reports of serious adverse reactions after new patches were applied without removing existing patches (especially with opioids).

The ISMP recommends nurses follow these guidelines to ensure the safe use of transdermal patches:

• Before applying the first dose, ask your patient if he’s wearing a patch that he put on at home.
• Chart on the medication record the site of application and the time patches are applied and removed.
• If a patch appears to have fallen off, carefully examine the skin in the area on which the patch was applied and in all other areas where the patch may have readhered.
• If patches are clear, apply a noticeable label to the patch that doesn’t obscure any existing drug information. Don’t use a pen directly on the patch because this can interfere with its integrity.
• Stress the proper use of transdermal patches to your patients, including proper application and removal, to reduce the risk of overdose.

Diet and regular soft drinks linked to increase in risk factors for heart disease
A study published in Circulation: Journal of the American Heart Association indicates that drinking more than one soft drink daily—regular or diet—may be associated with an increase in the risk factors for heart disease.

One part of the study looked at participants who were free of metabolic syndrome (a cluster of cardiovascular disease and diabetes risk factors including excess waist circumference, high blood pressure, elevated triglycerides, low levels of high-density lipoprotein, and high fasting glucose levels) at baseline. During a follow-up period of 4 years, the researchers found that participants who drank one or more soft drinks a day, whether regular or artificially sweetened, had a 44% higher risk of developing new-onset metabolic syndrome compared to those drinking less than one soft drink daily. The participants who drank one or more soft drinks a day also had a 31% greater risk of developing new-onset obesity; a 30% increased risk of developing increased waist circumference; a 25% increased risk of developing high blood triglycerides or high fasting blood glucose; and a 32% higher risk of having low high-density lipoprotein levels.

The researchers have called for additional studies to replicate the results and to understand the mechanisms driving this association before recommendations can be made.

African-American women diagnosed with more advanced breast cancer than Caucasians
A new, single-hospital study has shown that African-American women are more likely to present with later stage and higher-grade breast cancer tumors compared to Caucasian women. Published in the August 15, 2007 issue of CANCER, the study also found that tumors from African-American women contain more poor prognostic molecular characteristics than those from Caucasian women. Racial differences in breast cancer incidence and prognosis have been reported in many regional and national studies, so this study reflects national trends.

While Caucasians have the highest incidence of breast cancer, mortality in that group is among the lowest. African-Americans, conversely, have one of the lowest incidence rates but the highest mortality rate among women with breast cancer. It has not yet been determined if this disparity is due to health care access, intrinsic tumor genetics, or other factors; this study indicates that further investigation needs to be done to develop possible interventions to improve outcomes among African-American women.