In a stunning move, the FDA has approved a name change for the seizure medication Levetiracetam to simply Levet.
The U.S. Food and Drug Administration (FDA) recently approved a name change for an epilepsy medication from Levetiracetam to simply, “Levet”. The move marks a major shift in drug naming conventions as prior to now, drugs were typically named with nonproprietary names based on the drug’s chemical composition.
Levetiracetam, formerly known by the trade names Keppra XR and Keppra, was approved in 1999 as an add-on anti-seizure medication for adults and children aged four and up suffering from partial onset seizures.
In traditional drug naming conventions, Levetiracetam would have remained the generic drug name, and many of the brand-name formulations such as Keppra XR and Keppra, would have remained in use. However, due to the long length of its chemical name, the FDA determined that prescribing the medication or communicating about it may be difficult.
The FDA received numerous complaints from patients and caregivers about the difficulty of pronouncing and spelling the existing name. "We've heard from many people who have had difficulty with the name Levetiracetam," said FDA spokesperson Shelly Burgess. "The new name, Levet, should be much easier for people to manage."
Burgess said that the FDA is also working with the drug's manufacturer, UCB, to develop new and improved patient education materials that will help explain the change and avoid any confusion.
The decision by the FDA to allow abbreviated or alternate generic drug names is in recognition of this difficulty. It is believed that shorter, easier-to-pronounce generic drug names could help reduce medication errors and improve communication between patients, healthcare providers, and pharmacists by making drug orders easier to read and transmit.
Levetiracetam is the first approved drug name to take advantage of this new abbreviated name policy. While other drugs may also qualify for name changes, the ability to do so will remain relatively rare due to the specific rules and rigorous safety requirements set forth by the FDA.
The name change of Levetiracetam to Levet will become effective once the Levet capsules and tablets approved under the Levetiracetam ANDA become available in the market. It is expected that the new generic name will be used by pharmacists, healthcare providers, and other purchasers to order the drug.
The move by the FDA is seen to be a major step in the right direction in terms of reducing medication errors and improving communication related to prescription drugs. The new generic name, Levet, is believed to be an easier and shorter alternative to the long and difficult to pronounce name Levetiracetam, allowing for an easier understanding of the drug and its use.