Recent reports detailing widespread fake drugs might leave Americans wondering if the medicine in their cabinet is a counterfeit.
While fake drugs are more common in the developing world, they've taken a toll in this country and represent a persistent threat to patients here.
The Food and Drug Administration has issued warnings about substandard -- and illegal -- imported versions of the tumor-fighting drug Avastin three times in the past year, most recently shipments of a Turkish version of the drug. In 2008, there were at least 149 deaths and many more severe allergic reactions to tainted blood thinner imported from China. Other times, officials have seized drugs that include ingredients that have been banned in the U.S. for safety reasons.
A 2009 FDA crackdown on unauthorized online pharmacies led to the seizure of more than 800 packages that included Viagra, the pain reliever Vicodin and antihistamines. Some had three times the level of active ingredient they were supposed to, others none. Fillers included drywall, antifreeze and yellow highway line paint.
The World Health Organization estimates that 25 percent of drugs consumed in poor countries are counterfeit or substandard, some international watchdog groups say up to 50 percent of treatments sold in the developing world are fraudulent.
Counterfeit estimates for the U.S. are much lower -- 1 to 2 percent of drugs are fake, according to the FDA and the National Association of Boards of Pharmacy. It's assumed that federal and state authorities' tighter controls over manufacturing, distribution and retail sale of prescription and over-the-counter drugs reduce the incidence of fraud.
But with more than 4 billion prescriptions filled in the United States each year -- worth an estimated $310 billion -- even 1 percent translates to 4 million packages that either have no active ingredient or an insufficient amount, or that contain useless or even toxic fillers.
Counterfeiting in developed nations is more likely to involve drugs that are costly or in particular demand; products for erectile dysfunction, high cholesterol, hypertension, cancer and psychiatric conditions have often turned up.
Ineffective counterfeit drugs increase the worldwide risk of diseases that, instead of getting knocked out by effective treatment, become resistant.
One recent study published by the International Journal of Tuberculosis and Lung Disease found that nearly 17 percent of antibiotics prescribed against tuberculosis in Africa and 10 percent in India had less than 80 percent of the active ingredient to treat the disease. About 4 percent of drugs tested from Thailand, China, Turkey, Russia and Brazil were found to be ineffective.
The Institute of Medicine earlier this month called for a national drug-tracking system to ensure the use of genuine ingredients. In its report, commissioned by the FDA, the institute proposed technology such as barcodes or electronic tags that would be used from manufacturer to pharmacy to weed out adulterated pills or fake packaging.
It also urged states to tighten regulation of drug wholesalers and distributors, to toughen controls on Internet pharmacies, and to implement WHO international guidelines for product safety.
Some counterfeit copies of drugs are impossible to detect without a laboratory test. But the National Association of Boards of Pharmacy offers several red flags for consumers concerned that the drug they've been given is not legitimate. Watch out for:
-- Packaging that appears to have been opened or labels that appear different from those seen in the past;
-- Medicines that are cracked or chipped or have a different color or shape than you're used to;
-- A medicine that has a different taste or texture than you've previously experienced;
-- Adverse effects after taking the medicine -- side effects that you have not had before or that are not mentioned on warning labels.
If you suspect you have a fake drug, contact the FDA's Medwatch program (http://www.fda.gov/Safety/MedWatch/default.htm or 1-800-332-1088), or state pharmacy board, report it to the manufacturer or to the pharmacist that dispensed the drug.