Pemoline can cause serious and sometimes deadly liver damage. Tell your doctor if your child has or has ever had liver disease. Make sure your child keeps all appointments with the doctor and the laboratory. Your child's doctor will order lab tests before and during treatment to check if pemoline is affecting his/her liver.

If your child experiences any of the following symptoms, call his/her doctor immediately: loss of appetite, excessive tiredness, lack of energy, upset stomach, dark urine, and yellowing of the skin or eyes.

The FDA stated that it is aware of Health Canada’s decision to suspend sales, but not revoke the approval in Canada, of the drug ADDERALL as a treatment for Attention Deficit and Hyperactivity Disorder (ADHD). FDA has been in close consultation with the Canadian authorities regarding the basis for their action. FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports and FDA’s own knowledge and assessment of the reports received by the agency.

FDA has requested that Pfizer voluntarily withdraw BEXTRA from the United States market.  Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussion with the Agency.   At this time, the Agency has concluded that the overall risk versus benefit profile of Bextra is unfavorable.  This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, an increased risk of serious skin reactions, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.  

In an alert issued on 2/14/2005, the FDA confirmed that it is investigating reports of a possible connection between lymphoma and skin cancer in children and adults treated with ELIDEL (pimecrolimus) CREAM and PROTOPIC (tacrolimus) OINTMENT. Further studies are needed to establish whether or not there is a connection between the use of the drug and any reported adverse affects.

Continue to check back for the latest, most current devlopments on this emerging story. For more information about ELIDEL or PROTOPIC, please visit the FDA info-page for either drug.