Firm Announcements

Pharmaceutical

"If I can't get my epilepsy under control, my life is a disaster," writes Jason*, a 17-year-old epileptic. The teenager recently wrote to Joe and Teresa Graedon, who answers letters from readers in a regular column in the Chicago Tribune. Jason said he started taking the anti-seizure drug Keppra two years ago. The medication got his seizures under control and he went into remission. However, he recently moved to a new city and was switched to levetiracetam, a generic version of the drug. The results were devastating.




Recalls

Certain batches of the 6 French Engage Introducer a medical device used to implant catheters and electrodes into blood vessels during surgery to help prevent blood loss, are being recalled because the device's shaft, or sheath, has the potential to separate from the hub or break in the hub assembly. If this were to occur during use, a potentially life threatening episode of bleeding could occur.




Pharmaceutical

The brand name Keppra versus generic debate has escalated as more and more generic versions of Keppra have hit the market. While the Food and Drug Administration (FDA) has deemed the generics to be "bioequivalent" because the active ingredients are the same, doctors and patients are learning that differences in the inactive ingredients can have dangerous effects on the more sensitive systems of epileptics.




Environmental

BP Plc will face hundreds of lawsuits over the Deepwater Horizon disaster in federal court in New Orleans, a panel of judges ordered, a victory for plaintiffs seeking billions of dollars in damages for the largest offshore oil spill in U.S. history.




Pharmaceutical

Otsuka Pharmaceutical Co. and UCB have received manufacturing and marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the antiepileptic medication E Keppra in both 250 mg and 500 mg tablets. E Keppra, originally developed by UCB as Keppra, is now marketed in more than 90 countries worldwide, including the United States.




Pharmaceutical

Generic versions of Keppra were approved for marketing in the United States in 2009. Many insurance providers began ordering pharmacists to switch to the lesser expensive generic versions, often without patients' notice. The subtle differences between the brand name Keppra and its generic, known as levetiracetam, resulted in a return of seizures for many epileptics who made the switch. And, as Ruthie has found, that can be dangerous.




Recalls

Select vials of NeoProfen (ibuprofen Lysine), an injectable non-steroidal anti-inflammatory therapy used to treat a congenital heart disorder in premature infants, has been recalled by the Food and Drug Administration (FDA) because particulate matter was found floating in the medication. Particulate matter has the potential to obstruct blood vessels and could cause serious and potentially fatal complications. This recall will cause a temporary shortage in hospitals, the FDA reports.




Pharmaceutical

Cephalon, maker of the potent pain killer Fentora, has filed a citizen petition to the Food and Drug Administration (FDA) claiming that Watson Pharmaceutical's copycat version of Fentora differs chemically from Fentora and thus should have to go through a lengthier approval process reserved for new drugs rather than the shorter process reserved for generic drugs. This is Cephalon's latest attempt to block generic competition for Fentora, which had sales of $87 million during the first six months of 2010.




Pharmaceutical

Gustav was on the anti-seizure medication Keppra for a year when his insurance company switched him to a generic version of the drug, known as levetiracetam. The safety of formulation switching is one of the top priorities of the Epilepsy Foundation. A survey conducted by the nonprofit organization found that epileptics who switch from one anti-seizure medication to another, in particular from a brand name to a generic, often suffer serious side effects, including a return of seizures, that for some has been fatal. Levetiracetam is also one of several drugs that has been linked to a serious skin condition known as Stevens Johnson Syndrome (SJS).




Pharmaceutical

The biggest thing that bothers Dura about having epilepsy is the deju vu. "Such a weird sensation, I wish it would go away," she wrote to other epileptics on a forum. She started off taking the generic version of Keppra, but noticed the drug made her stutter and slur her words. She also developed a headache that lasted a full two months. When she suffered a huge partial seizure she decided to switch to brand-name Keppra.