FDA NEWS

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA investigating TNF blockers and cancer risk in children and young adults.

Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin
In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre...

Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder
Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants.

Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps
On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ...

Regranex (becaplermin) Gel
Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex.

Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information...

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

Recalls and Safety Alerts: Neupro Patches Recalled
Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th...