The FDA has mandated updated warning labels for Pfizer’s Comirnaty and Moderna’s Spikevax COVID vaccines, acknowledging increased risks of myocarditis and pericarditis that have emerged from ...

What is Dsuvia? What you should know about the new opioid drug that's 10 times stronger than fentanyl. An FDA advisory panel voted in favor of approving the drug in early October.

If TUSSIONEX Pennkinetic is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be ...

Companies that manufacture powerful, long-acting opioid painkillers will have to sponsor education programs about how to appropriately prescribe their drugs, according to the FDA.

FDA adds warnings for painkiller Bextra. The Associated Press; Dec 10, 2004 Dec 10, 2004 Updated Oct 17, 2018; ... FDA said in a statement that it was adding the heart warning to the Bextra label ...

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety ...

FDA expands COVID shots heart risk warnings. by CNN/CNN Newsource. Thu, May 22nd 2025 at 4:03 AM ... — The Food and Drug Administration has expanded the heart risk warnings connected to COVID-19 ...

The U.S. Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include information on two rare heart side effects: myocarditis and pericarditis.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY ...