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A drug recall removes a prescription or over-the-counter drug from the market. Prescription drugs were designed to make us feel better. However, the side effects may turn out to be incredibly harmful, even deadly. Worse, they may not show up for years. When a dangerous side effect is identified, the Food and Drug Administration (FDA) works with the drug manufacturer to issue a recall. Unfortunately, this process can be lengthy, leaving dangerous drugs on the market and in the hands of unsuspecting consumers. Dangerous prescription drugs can cause everything from allergic reactions to heart attacks and cardiac arrest. Often times, defective or dangerous prescription drugs are voluntarily recalled by the drug manufacturer. If the FDA becomes involved, it can request a recall, which companies usually follow. An FDA-issued recall is the fastest way to remove a harmful drug from the market. The FDA’s Role The FDA is responsible for ensuring the safety and efficacy of a variety of products, from prescription drugs to medical equipment. The FDA provides timely and important clinical information about safety issues involving a variety of prescriptions, medical foods and supplements. The FDA then announces product safety alerts, recalls, withdrawals, and important label changes that may affect the public’s health. Recently, the FDA announced an initiative to be more aggressive in protecting Americans’ health. Drug Recalls A recall is an action taken to remove a product from the market entirely. There are different levels of drug recall: Class I Recalls: Many recalls are Class I recalls, where there is a reasonable probability that using this product can lead to severe injury or death. Class II Recalls: This recall is issued when exposure to a product can cause a temporary or medically-reversible injury. Class III Recalls: These are for products that violate FDA labeling or manufacturing regulations. This may be a container defect, wrong color, or odd taste, but are not likely to cause consumer injury. Defective drug recalls may be publicized in newspapers and in news broadcasts. However, the FDA will only publicize a recall when it believes the public should be notified about a serious hazard. The FDA expects drug manufacturing companies to take complete responsibility for product recalls. This includes follow-up checks to ensure that a drug recall is successful. Once a recall is completed, the FDA makes sure that the product is destroyed or correctly modified. It then investigates why the product was defective. Safety Alerts A safety alert is a notice or warning that is issued when a drug or product presents an unreasonable risk of significant harm. In certain situations, these cases are also considered recalls. About 20 million patients took at least one of defective drug that was later recalled between 1997 and 1998. Since 1993, dangerous pharmaceuticals have led to at least 1,000 deaths. In recent years, the most serious drugs recalls have been among diet pills cholesterol-lowering medications. There are still countless drugs on the market that have been issued safety warning or notices from the FDA. Some of these include: Serzone (an anti-depressant) Arava (an arthritis medication) Vioxx (an anti-inflammatory medication) Prempro (a hormone-replacement treatment pill) Aside from prescription drugs, a number of popular herbal and dietary supplements, such as ephedra-based supplements, have been connected to serious health issues.
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