Prescription Drug Articles
Drug Articles
Black Box Warnings
Monday, 05 September 2011 23:36 |
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A black box warning is a warning that is included in the package insert for prescription drugs that can cause serious adverse effects. The warning is also included in literature that is distributed to health care providers. The warning can be identified by the black border that surrounds the warning. A black box warning is the strongest warning issued by the FDA that a drug can carry and still remain on the market. The presence of a black box warning in a drug’s package insert means that medical studies have shown that the drug carries a significant risk of serious or life-threatening adverse effects. The FDA requires a black box warning when the drug can cause serious adverse effects that outweigh the potential benefits of the drug and when a serious adverse reaction can be prevented or reduced in frequency or severity through the proper use of a drug. Black box warnings must provide a summary of the adverse side effects and risks associated with taking the drug. Black box warnings have been required for many drugs, including antidepressants, Celebrex, Depo-Provera, ADHD medications, Avandia, Cipro, Levaquin, Avelox, Noroxin and Floxin. While it is important to be aware of the importance of a black box warning and to discuss it with a health care provider, the presence of a label does not mean that a person should not use a drug that has a black box warning. |
Prescription Drugs in the U.S.
Monday, 05 September 2011 23:01 |
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A prescription drug is a licensed medication that is regulated by legislation. As opposed to over-the-counter drugs, one must obtain a prescription from a health care provider in order to obtain the drug. The Federal Food, Drug and Cosmetic Act (the “Act”) defines which drugs require a prescription. The Act defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Prescriptions are generally issued by dentists, optometrists, medical practitioners and advanced practice nurses. The Federal Prescription Drug Marketing Act of 1987 regulates the safety and effectiveness of prescription drugs. The Food and Drug Administration (“FDA”) administers this law. The FDA reviews the safety and efficacy of new prescription drugs before those drugs are approved for sale. A drug that is approved is deemed to be “safe and effective when used as directed.” The FDA also regulates the manner in which prescription drugs are advertised and promoted. With regard to advertising, a pharmaceutical company may only advertise a drug for the specific indication or medical use for which it was approved. In addition, an advertisement must maintain a “fair balance” between the benefits and risks of the drug. After a prescription drug has been approved, the FDA monitors adverse effects that are potentially linked to the prescription drug. The FDA’s continued regulation of prescription drugs is important given the number of people who use prescription drugs. Over the past decade, the percentage of Americans who were prescribed at least one prescription drug in the past month increased by 10%. The percentage of people who had multiple prescription drugs increased by 20%, while the percentage of those who used five or more drugs increased by 70%. In 2009, prescription drug sales in the United States grew by 5.1%, reaching $300.3 billion in sales. The four highest grossing classes of prescription drugs were antipsychotics, lipid regulators, proton pump inhibitors and antidepressants. A total of 3.9 billion prescriptions were dispensed in the United States in 2009 alone.
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