FDA warning news from FiercePharma
NewsEnbrel gets black-box infection warning
Enbrel's new black box is now official. Wyeth and Amgen have put the final touches on a Read more...
Pharma growth drops to 1961 levels
IMS Health is out with its new annual pharma sales report, and it ain't pretty. Revenue grew by only 3.8 percent to $286.5 billion, the slowest pace of expansion since 1961. By contrast, sales Read more...
Top 10 Drug Warnings and Recalls of 2007
2007 has been a year of high-profile drug safety warnings. Check out this report for a look at the 10 biggest drugs with new, FDA-issued warnings or withdrawals this year. The drugs are ranked by Read more...
ED drugs slapped with new warning
Here's a trade-off that could have been dreamed up by a Puritan: Treat your ED, go deaf. The FDA is adding new warnings of sudden hearing loss to three of the popular ED drugs--Read more...
Lilly diabetes med linked to pancreatitis
A fast-growing Eli Lilly med may be held back by a new warning linking it to acute pancreatitis. After 30 reports of pancreatitis in patients using the injectable diabetes drug Byetta--five of which Read more...
FDA to slap black box on ultrasound drugs
Sometimes, seeing clearly is dangerous. Or so says the FDA, which is prepping a warning for doctors who use drugs to help diagnose heart problems using ultrasound imaging. The agency has been Read more...
Red flags raised on Fentora misuse
Pain can be a killer. Cephalon officially warned doctors yesterday to use its opioid pain reliever Fentora very, very carefully, or patients might die. Some already have, while others have Read more...
Patch delivers killer doses
Dear FDA: Sometimes warnings don't get through--just witness the Surgeon General's stamp on cigarette packages. Or, closer to home, consider the cautionary language slapped onto painkiller patches. Read more...
| Press ReleasesPRESS RELEASE: FDA MedWatch - Desmopressin Acetate FDA MedWatch - Desmopressin Acetate - Product Labeling Updated To Include Important New Information About Severe Hyponatremia And Seizures ROCKVILLE, Md., Dec.4, 2007-- FDA notified healthcare Read more... PRESS RELEASE: FDA Issues Early Communication for Chantix FDA Issues Early Communication for Chantix Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid Read more... PRESS RELEASE: Early Communication About an Ongoing Safety Review Early Communication About an Ongoing Safety Review Cefepime (marketed as Maxipime) This information reflects FDA’s current analysis of available data concerning these drugs. Posting this Read more... PRESS RELEASE: FDA Sends Sanofi Warning Letter for Ketek Study FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more... PRESS RELEASE: FDA Announces Revisions to Labels for Cialis, Levitra and Viagra FDA Announces Revisions to Labels for Cialis, Levitra and Viagra Potential risk of sudden hearing loss with ED drugs to be displayed more prominently The U.S. Food and Drug Administration has Read more... |
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