What is a Drug RecallABOUT DRUG ALERTS, DRUG WARNINGS, AND DRUGS RECALLS. The United States Food and Drug Administration (FDA) monitors the approval, use, and safety of prescription drugs. Following numerous adverse reaction reports of side effects or deaths from consumer use of prescription or over-the-counter drugs, the FDA may issue various types of warnings to consumers and healthcare professionals, such as dear doctor letters, safety alerts, public health advisories, black box warnings, and recalls. Although all of these warnings are serious in nature, black box warnings tend to be the last courtesy extended to pharmaceutical companies before the FDA initiates a drug recall.
A BLACK BOX WARNING IS THE STRONGEST WARNING FOR ANY PRESCRIPTION DRUG. In the United States, a black box warning (also called a black label warning or boxed warning) is a specific warning that is placed on a prescription drug package insert when it is determined that the prescription medication may cause serious adverse side effects. The black box warning is so named for the black border that typically highlights the warning label.
BLACK BOX WARNINGS MAY FOLLOW REPORTS OF SERIOUS INJURY OR DEATH. Black box warning often follows adverse reports provided to the U.S. Food and Drug Administration (FDA) or medical studies that indicate that a prescription drug has significant risk of serious injury or life-threatening adverse effects. The FDA may require a pharmaceutical company to place a black box warning on prescription drug packaging, and include the black box warning information on materials describing the prescription drug.
After a drug has been on the market for some time, issues pertaining to its safety or related side effects sometimes emerge. These safety and side effect issues arise either through continued clinical research or, more commonly, through adverse events reported by consumers or physicians. Following these concerns and knowledge of side effects related to specific medications, the FDA has two options: 1) It can choose to completely remove the drug from the market in a drug recall, or, 2) The FDA can issue an advisory or warning, the strongest of which is a black box warning that appears on the drug's printed materials, both inside the packaging and on materials developed for the doctors who may prescribe the drug.
Black box warnings have received increased attention in the last decade. In 2004, for example, the popular birth control shot, Depo-Vera was required to carry a black box warning due to the risk of significant bone density loss with long-term use. In November of 2007, the FDA added a black box warning to the diabetes medication Avandia, citing the risk of heart failure or heart attack to patients with underlying heart disease. On July 8, 2008, the FDA required manufacturers of systemic fluoroquinolone antimicrobial drugs to carry a black box warning regarding the increased risk for tendonitis and tendon rupture. Fluoroquinolone products affected by the labeling changes include ciprofloxacin (Cipro, Bayer; and generics), extended-release ciprofloxacin (Cipro XR, Bayer; Proquin XR, Depomed), gemifloxacin (Factive, Oscient), levofloxacin (Levaquin, Ortho McNeil), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), and ofloxacin (Floxin, Ortho McNeil; and generic).
More recently, the FDA added a black box warning to the label of the blood thinner, Plavix, after reports of some patients not being able to process it, due to a genetic variation. Plavix is a drug that is prescribed to heart disease patients to prevent dangerous blood clots. Plavix must be broken down by an enzyme, which 2 to 14% of people have low levels of, in the liver. Also known as the world's second bestselling drug, it's marketed by Bristol-Myers Squibb, and had 8.6 billion in sales in 2008.
CAREFULLY MONITOR YOUR PRESCRIPTION DRUGS AND KNOW ABOUT SIDE EFFECTS AND WARNINGS: The FDA's black box warning can be found on many other drugs that have been approved as well, so it's important to understand that this label doesn't mean that you shouldn't use a particular drug, but you should be aware and cautious of the drug’s side effects.
