FDA Orders New Warnings and Revised Prescribing Information for 35 Drugs
FDA issued a Drug Safety Labeling Changes Prescribing Information Issued By FDA. The Food and Drug Administration (FDA) issued a Drug Safety Labeling Changes announcement that lists label changes and revised prescribing information for 35 different products. The changes involve Contraindications, Warnings, Precautions, and … [Read more...] about FDA Orders New Warnings and Revised Prescribing Information for 35 Drugs
Acetaminophen to Carry New Warnings
FDA's Updated OTC Acetaminophen Drugs. A new draft guidance document issued by the U.S. Food and Drug Administration (FDA) orders new warnings on all over-the-counter (OTC) acetaminophen medications to include the risk of serious skin reactions. Last August, the agency warned that acetaminophen is associated with Stevens-Johnson … [Read more...] about Acetaminophen to Carry New Warnings
Tussionex Death Report Prompt New Warnings from FDA
Tussionex Death Reports. Tussionex, a prescription cough medicine manufactured by UCB SA, has been linked to numerous side effects and some deaths, and the Food and Drug Administration (FDA) is said to be considering issuing a public warning for Tussionex. UCB SA, a Belgian company, recently contacted the FDA about updating safety … [Read more...] about Tussionex Death Report Prompt New Warnings from FDA
Myfortic Gets New Warnings for Birth Defect, Miscarriage Risk
Myfortic Can Cause Birth Defects. Myfortic, a drug used to prevent organ rejection in transplant patients, has been linked to drug side effects that include an increased risk of birth defects and miscarriage. Because of this, the Food & Drug Administration (FDA) has added a new boxed warning to the Myfortic label, and … [Read more...] about Myfortic Gets New Warnings for Birth Defect, Miscarriage Risk
Viagra, Cialis, Levitra Users Report Hearing Loss
Viagra, Cialis, Levitra Users Report Sudden Hearing Loss. Viagra, Cialis, Levitra have been connected with more than two dozen instances of sudden hearing loss. Last week, those reports prompted the Food & Drug Administration (FDA) to announce that the labels on these erectile dysfunction drugs would bear new warnings … [Read more...] about Viagra, Cialis, Levitra Users Report Hearing Loss
ADHD Drugs to Get New Warnings
The FDA Ordered All Manufacturers Of ADHD Drugs To develop Medication Guides. The U.S. Food and Drug Administration (FDA) announced today that it is ordering all manufacturers of attention deficit hyperactivity disorder (ADHD) medication to develop Patient Medication Guides to warn patients of potentially serious side effects. The … [Read more...] about ADHD Drugs to Get New Warnings
FDA Adds New Warnings to Avastin
Avastin May Cause RPLS. Genentech Inc. has added warnings about a rare brain condition called reversible posterior leukoencephalopathy syndrome, or RPLS, in patients using its cancer drug Avastin, the Food and Drug Administration said. The drug's label also now includes information about seven reports of patients who developed … [Read more...] about FDA Adds New Warnings to Avastin
New ADHD Drug Warnings
ADHD Drugs Side Effects Warning. The Food and Drug Administration plans to add new warnings about psychiatric side effects to the label of Concerta and other drugs for attention deficits and hyperactivity, according to documents posted on the FDA Web site and confirmed by the agency. At a meeting today of the FDA's Pediatric … [Read more...] about New ADHD Drug Warnings
Look For New Warnings About Lead Paint
Warnings About Lead Paint Hazards. Some 25 years after lead paint was banned, the paint industry's trade association and 50 attorneys general have agreed to put warnings about lead-paint hazards on cans of new paint. The main label will have to make the following disclosure: WARNING! If you scrape, sand, or remove old paint, you … [Read more...] about Look For New Warnings About Lead Paint
FDA, Pharmacia Update Bextra Label W/ New Warnings
Bextra Label New Warnings. FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling is being updated with new warnings … [Read more...] about FDA, Pharmacia Update Bextra Label W/ New Warnings
