FDA NEWS

Recalls and Safety Alerts: Recall of Zencore Plus
Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: www.accessdata.fda.gov

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
There may be an association between the use of stimulant medications for attention- deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study’s limitations, parents should not stop a child’s stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional.
Source: www.fda.gov

U.S. Attorney News Release: International Medical Device Maker and Four Executives Charged in Connection with Unlawful Clinical Trials
U.S. Attorney news release
Source: www.fda.gov

FDA Promotes Openness and Transparency to Public
FDA is working to make useful information about FDA activities and decision making more readily available to the public.
Source: www.fda.gov

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
Source: www.fda.gov

FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.
Source: www.fda.gov

U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food
KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.
Source: www.fda.gov

U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion
CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.
Source: www.fda.gov

Recalls and Safety Alerts: Raptiva Withdrawn from the Market
Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by...
Source: www.accessdata.fda.gov

Safety Concerns About Testosterone Gel
Side effects in children prompt additional warnings on testosterone gel products for adults.
Source: www.fda.gov