Did you suffer side effects from the drug Keppra? Keppra (Levetiracetam) is an anticonvulsant commonly used in combination with other medications to treat partial onset seizures in people 16 years of age and older with epilepsy. Manufactured by UCB, Keppra was first approved on November 30, 1999.
Lawyers at Parker Waichman LLP who investigate defective drug lawsuits are investigating possible Keppra side effects, including suicidal thoughts and behavior, as well as birth defects and congenital abnormalities in children born to women treated with Keppra. Our firm is also investigating possible injuries from generic versions of Keppra stemming from a reported lack of effectiveness. If you or someone you loved used Keppra and suffered a serious side effect, you may be entitled to file a Keppra lawsuit to obtain damages for your medical bills, lost wages, and pain and suffering. Our defective drug lawyers are offering free lawsuit consultations to victims of potential Keppra side effects. To learn more about the legal remedies available to you, please contact our Keppra side effect lawyers for your free evaluation today.
Keppra (Levetiracetam) and Suicidal Thoughts, Behavior
In 2005, the U.S. Food & Drug Administration (FDA) launched an investigation to determine if newer epilepsy drugs, including Keppra, posed any suicide risk. In 2008, the agency issued an alert warning that its review of almost 200 studies involving 11 drugs, including Keppra, indicated that people taking those drugs were twice as likely to suffer from suicidal thoughts and behavior as those taking a placebo.
The FDA studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills. According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. There was no clear pattern of risk across age groups.
Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. According to the FDA for every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.
Keppra (Levetiracetam) and Birth Defects
The FDA currently has Keppra placed in Category C (“no known human risk”) for pregnancy. In September 2011, however, AdverseEvents, Inc. reported that its analysis of the FDA’s Adverse Event Reporting System (AERS) indicated that Keppra was more dangerous to unborn babies than previously thought. In conducting its analysis, AdverseEvents used a proprietary process called RxFilter to analyze the FDA’s AERS database for treatment-related birth defects, stillbirths and congenital abnormalities potentially associated with 18 anti-epilepsy medications, including Keppra, that are commonly prescribed during pregnancy. The time period covered by the AdverseEvents analysis was January 1, 2004 to March 31, 2011.
According to AdverseEvents, an average birth defect rate comparison between Keppra and top Category D drugs (positive evidence of human fetal risk”) yielded no meaningful difference. The company said the results indicated that more study of Keppra’s fetal risk was necessary, and that a move from pregnancy Category C to D might be warranted.
Generic Keppra Injuries
Our defective drug lawyers are also investigating reports of injuries associated with generic forms of Keppra approved by the FDA in 2009. Reportedly, patients who switch from Keppra to the generic, Levetiracetam, are experiencing increased reoccurrence of seizures after having been seizure-free on the brand name drug. Additionally, there have been reports of injuries and at least one death resulting from a patient who suffered a seizure and died after being switched from Keppra to the generic drug.
All generic medications must undergo certain tests to compare them to brand-name medications.. However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities. Many health care providers believe that special care should be taken when switching a patient from a brand-name seizure medication to a generic one, or even switching between different generic versions of a medication.
Legal Help for Victims of Keppra Side Effects
If you believe you or someone you love was injured by Keppra, you may have valuable legal rights. To learn more about filing a Keppra side effects lawsuit, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.