The recall involves Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. This product can be uniquely identified as an oval peach colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall.
Super-potent tablets could lead to clinically significant adverse reactions including cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.
Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately. Consumers with questions may contact 888-742-5578 from 8:00am - 8:00pm EDT Monday-Friday.
Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm.
ADHD is a condition that becomes apparent in some children in the preschool and early school years. It is hard for these children to control their behavior and/or pay attention. It is estimated that between 3 and 5 percent of children have ADHD, or approximately 2 million children in the United States. Stimulant medications like Ritalin are known to improve ADHD symptoms, but they come with side effects.
Stimulants, like Adderall and Ritalin, are known to raise blood pressure. In 2006, the FDA added a “black box” warning to the labels of ADHD drugs warning of cardiovascular risks associated with the medications. The heart-related problems cited by the new warning included sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate.
Until now, no long term studies had been done on the heart risks associated with Ritalin, Adderall and other ADHD stimulants. Now, new research published in the journal “Pediatrics” suggests that such medications do cause some heart symptoms. The article details a study that looked at data on 55,383 Florida children ages 3 to 20 years who had ADHD. About 59 percent were taking a stimulant medication during the study period (1994 to 2004). Children taking a stimulant to control ADHD symptoms were 20 percent more likely to visit an emergency clinic or doctor's office with heart-related symptoms, such as a racing heartbeat, than children who had never used or discontinued treatment. However, rates of death or hospital admission for serious heart conditions were no different than the national rates among the general population.
Despite the apparent good news on serious heart conditions and deaths related to ADHD stimulants, the authors of the “Pediatrics” article asserted that there was a great need for more research on the long-term effects of these drugs. Given that 3 to 4 million children take stimulant medications like Ritalin to control symptoms of ADHD, they wrote that further studies need to be done to determine the consequences of chronic stimulant use during childhood on heart disease in adulthood.
This is not the first time the safety of ADHD drugs have been called into question. A small study conducted by he University of Texas and the M.D. Anderson Cancer Center found a link between Ritalin and increased risk of cancer. While this research only involved 12 children, those taking Ritalin all experienced a significant increase in the chromosomal abnormalities associated with an a higher chance of developing cancer. Other known side effects of ADHD stimulants include loss of appetite, abdominal pain, sleep problems and headaches.
The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.
All of this controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children. In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.
There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.
The panel ˘â‚¬â„˘s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications.
During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.
In attempting to lay the foundation for ignoring the panel ˘â‚¬â„˘s vote, officials said they would be reluctant to require a black box warning based on a ˘â‚¬Ĺ“theoretical risk. ˘â‚¬ ť
Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. He stated: "The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm."
Thus, Temple indicated the full FDA would wait for the recommendation a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.