Barr Laboratories is recalling one lot of its generic Adderall due to a serious manufacturing defect, the Los Angeles Times reported Aug. 14. The laboratory is recalling lot number 311756 of the 20-mg, 110-count bottles of Adderall, a mixture of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The manufacturer started the recall after finding that some of the pills in the lot were oversized, which can lead to an overdose causing heart arrhythmia, heart palpitations, high blood pressure, anxiety, insomnia and other side effects. Patients who have this lot of the drug are advised to stop taking it and return it immediately to their pharmacy, or call Barr Laboratories for more information at 1-888-742-5578.
Adderall is a drug used in children and adults with attention deficit hyperactivity disorder (ADHD). It is a mixture of several salts from the amphetamine family of drugs, which also contains the street drug methamphetamine. Like methamphetamine, Adderall is a stimulant that can cause severe adverse effects in an overdose, including mental health problems as well as potentially serious effects on the heart and cardiovascular system. Barr Laboratories’ press release lists potential physical effects of an overdose such as increased heart rate, high blood pressure, heart palpitations, tremors, dizziness, insomnia and nausea. Possible psychological side effects of the oversized pills include anxiety, euphoria, mania and agitation.
Fortunately, the manufacturer and the FDA did not report hearing of any dangerous side effects from the oversized, defective pills. But as a dangerous prescription drug lawyer, I know ADHD drugs and stimulants generally have a troubled history when it comes to safety. Adderall and other stimulants are not prescribed to people with a history of heart problems, seizures or drug abuse because they can be dangerous or even fatal for all of those groups. Furthermore, studies have shown that they can cause changes in vision and stunt children’s growth, at least temporarily. And in 2006, an FDA advisory panel voted to put a black box warning on the drug’s label about potential cardiovascular and mental health side effects in children — a recommendation the FDA ignored.
The current recall should not be a cause for alarm for all patients taking Adderall; only one lot is affected. But because an overdose of amphetamines can be very serious, patients who purchased the oversized pills are at risk of health- or life-threatening side effects. Like all drug manufacturers, Barr Laboratories is strictly liable for the damage its products cause if they have a manufacturing defect — even if they didn’t know about the problem ahead of time. Any patients who are seriously harmed by the oversized pills would have the right to hold the manufacturer legally responsible with a defective prescription medication lawsuit.
Carey, Danis & Lowe represents clients around the United States who have been harmed in this way by a drug or medical device with serious safety problems. Frequently, these patients are left not only injured or disabled by the defective drug, but also holding the six-figure bills for treating the problems the original “treatment” caused. Our pharmaceutical liability attorneys help victims recover those costs and all other costs related to the injury, as well as compensation for the loss of a loved one, a permanent disability or serious injuries. Based in St. Louis and Belleville, Ill., we represent clients throughout the Midwest and the United States.
If you were seriously hurt after using a drug or medical device with safety problems and you’re ready to explore your legal options, the Lowe Law Firm can help. To set up a free consultation, please contact us through our Web site or call 1-877-678-3400 toll-free from anywhere in the U.S.