The FDA has broadened the indications for methylphenidate (Concerta) extended-release tablets in doses of 18 mg to 72 mg/day to include adults with attention-deficit hyperactivity disorder (ADHD).
The FDA added a boxed warning to the label of Regranex Gel 0.01% (becaplermin)--a topical cream for treating stubborn leg and foot ulcers in diabetic patients--due to increased risk of death from cancer.
The FDA has acted to require manufacturers of an older class of drugs known as conventional antipsychotics to add boxed warnings to their labeling about an increased risk of death associated with their off-label use to treat behavioral problems in older patients with dementia.
Following positive tests for Burkholderia cepacia, Sage Products has announced a voluntary recall of limited lots of its 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product.
United States marshals seized more than $1.3 million worth of dietary supplements from LG Sciences, LLC, of Brighton, Michigan, because the products contain unapproved food additives and/or new dietary ingredients.
The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries...
The FDA has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending approval from the Chinese government.
The FDA has identified 25 drugs and biologic products that will be required to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) safety plan by September 21, 2008.
The FDA issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous adverse event reports, including death, associated with the misuse and inappropriate use of the strong cough medication.
Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach last month announced the appointment of Janet Woodcock, MD, as director of the agency's Center for Drug Evaluation and Research(CDER), a position she has held previously.
Citing such false claim as "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications" and "Greatest STD Protection Without Condoms" (SlicPlus), the FDA issued Warning Letters to six U.S. companies and one foreign individual for marketing misbranded and unapproved drugs over the Internet.
The FDA announced that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death.
Reacting to emerging evidence of a link between the smoking cessation drug Chantix (varenicline) and serious neuropsychiatric symptoms, the FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings.
The FDA said that it would take enforcement action against companies marketing unapproved injectable colchicine, used to treat gout. Colchicine is a highly toxic drug, especially when given intravenously, and the FDA is aware of 50 reports of adverse events connected to intravenous colchicine, including 23 deaths.
The FDA announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable drug heparin, commonly used before surgery as a blood-thinning agent, due to reports of serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.
Potential Drug Mixup Warning Concerned about possible confusion between the drugs edetate diso!=dium and edetate calcium disodium, the FDA issued a public health advisory.
Prison Sentences for Women Who Claimed ALS Cure The FDA Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.
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