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Your Resource for Adverse Reactions and Drug Recalls
Going back in time, people have sought out remedies that would alleviate pain, discomfort, and disease. From plants and foods to sunlight or cold or heat, there have been many “cures” presented through the ages. As we have come into more modern times, companies and individuals have continued to seek out cures and, thankfully, today many are found. Each of us can be thankful for drugs we take for granted like penicillin or the polio vaccine. Each of these drugs has changed the lives of nearly everyone on the planet. But, any drug when taken incorrectly can do harm. A common drug, acetaminophen was lauded when it first came on the market as another anti fever, anti pain drug. The beauty of it was that for those who did not… 
In the United States, a black box warning (or “black label warning” or “boxed warning”) is the sternest warning that the Food and Drug Administration can issue for a medication and still allow it to remain on the market. A black box warning will appear on the medication’s label, insert and all other literature associated with the drug, such as magazines advertisements. The warning is named for and easily distinguished by the black border that surrounds its text and will contain a concise summary of the risks associated with taking the medication. The FDA will issue a black box warning for a drug when medical studies indicate that the drug carries a significant risk of serious undesirable effects, such as a fatal, life-threatening or permanently disabling adverse reaction, when compared…
Johnson & Johnson recently settled suit involving Risperdal just prior to trial. Allegations included the connection between antipsychotic drug Risperdal and abnormal breast growth in youth. In 2003, The FDA warned that a “The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a “Dear Healthcare Provider” (DHCP) Letter for Risperdal® (risperidone) disseminated by Janssen Pharmaceutical, Inc. on November 10, 2003. DDMAC has concluded that the DHCP letter is false or misleading in violation of Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 352(a) and 321(n)) because it fails to disclose the addition of information relating to hyperglycemia and diabetes mellitus to the approved product labeling (PI), minimizes the risk of hyperglycemia-related adverse events, which in extreme cases is associated with serious adverse events including ketoacidosis, hyperosmolar coma, and death, fails to recommend regular glucose control monitoring to identify diabetes mellitus as soon as possible, and misleadingly claims that Risperdal is safer than other atypical antipsychotics. The healthcare community relies on DHCP letters for accurate and timely information regarding serious risks and associated changes in labeling and the dissemination of this letter at a time critical to educating healthcare providers is a serious public health issue. . . “
