Health Canada is investigating the use of NSAIDs at 20 weeks or later in pregnancy and the rare, but serious, risk of kidney problems in an unborn baby that can lead to low levels of amniotic fluid and possible complications, in response to a Drug Safety Communication recently released by the U.S. FDA on this...
Tag: FDA
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HPV Vaccine
FDA approves the use of GARDASIL Vaccine up to 45 years old. Human Papillomavirus Vaccine helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by HPV. GARDASIL helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by...
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Newer Shingles Vaccine
A new herpes zoster (HZ) subunit vaccine (HZ/su) appears to be more effective especially among elderly and longer duration of protection and less costly than the currently used live attenuated HZ vaccine (ZVL) at all ages, a new study published online January 2 in JAMA Internal Medicine shows. The US Food and Drug Administration (FDA) approved the...
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Misuse and Abuse of Antidiarrheal Loperamide- January 2018
FDA announced new action to combat the growing problem of abuse and misuse of the opioid-based antidiarrheal medication loperamide (Imodium). In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse. The FDA notes that some individuals...
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Opioid Cough Medicines under 18 Years Old
The FDA will require label changes that limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone to adults aged 18 years and older. In addition, the agency will require added safety information highlighting the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the “boxed warning”...