FDA warns of increased thoughts of suicide associated with antiepileptic drugs
WASHINGTON The Food and Drug Administration has released information stating that there is an increased risk of suicidal thoughts in patients taking antiepileptic drugs to treat epilepsy, bipolar disorder, migraine headaches and other conditions.
In March 2005, the FDA requested data from controlled clinical trials conducted by manufacturers of marketed antiepileptic drugs following a preliminary analysis of data from several antiepileptic drugs that suggested an increased risk of suicide. The FDA reviewed data from 199 placebo-controlled studies of 11 drugs.
An analysis from the studies showed that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidal thoughts than in the placebo groups.
The analysis included 27,863 patients in drug treatment groups and 16,029 patients in placebo groups. There were four suicides among patients in the drug treatment groups and none among patients in placebo groups. There were 105 reports of suicidal thoughts or behaviors in the drug-treated patients and 35 reports in placebo-treated patients.
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.
The FDA released the names of the antiepileptic drugs in the analyses, which included the following:
- carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
- felbamate (marketed as Felbatol)
- gabapentin (marketed as Neurontin)
- lamotrigine (marketed as Lamictal)
- levetiracetam (marketed as Keppra)
- oxcarbazepine (marketed as Trileptal)
- pregabalin (marketed as Lyrica)
- tiagabine (marketed as Gabitril)
- topiramate (marketed as Topamax)
- valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
- zonisamide (marketed as Zonegran)
Although only the drugs listed above were part of the analysis, the FDA expects that all medications in the antiepileptic class share the increased risk of suicide.
The FDA will be working with manufacturers of antiepileptic drugs to include this new information in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. The FDA is also planning to discuss these data at an upcoming advisory committee meeting.
Despite solid fourth quarter, Wyeth cautious about 2008
MADISON, N.J. Wyeth released its 2007 fourth-quarter report and it showed that while the company profited in the fourth quarter, the company expects 2008 to be an off year, according to published reports.
Wyeth said net income for the three months that ended Dec. 31 rose to $1.02 billion from $855.4 million. Wyeth’s fourth-quarter sales rose 10 percent to $5.76 billion from $5.22 billion a year earlier. Sales of Effexor rose 3 percent to $968 million.
Wyeth, though, now is facing trouble for 2008, and it comes in the form of generic competition. Generic manufacturers recently began selling copycat versions of Wyeth’s drug Protonix, for heartburn, which is expected to erode sales of Wyeth’s product.
Wyeth said it planned on seeking lost profits and other damages from the generics companies in a patent-infringement trial expected later this year. Protonix had $1.9 billion in sales in 2007. Wyeth also faces potential new generic competition for two other major drugs, the antidepressant Effexor and antibiotic Zosyn.
Sales of Effexor rose 3 percent to $968 million, but those sales might take a hit if Sun Pharmaceuticals launches a tablet version of the extended release version of Effexor in the summer.
Protonix sales rose 10 percent to $461 million. But Wyeth has lost U.S. market exclusivity for the drug after generic drugmakers Teva Pharmaceuticals and Caraco Pharmaceutical Labs—owned by Sun—launched copycat versions, despite the existence of a patent set to expire in 2010. Wyeth this week began selling its own generic Protonix in partnership with Prasco Laboratories.
Wyeth said it now expects 2008 earnings of $3.35 to $3.49 per share, excluding certain items, representing a decrease of 1 to 5 percent from 2007 levels. Analysts had expected 2008 earnings of $3.54 per share. The company also expects to cut its 50,000-employee workforce by 4-to-6 percent during the middle of this year,
Teva launches generic Protonix
NORTH WALES, Pa. Teva has launched its newest drug, a generic version of the Wyeth acid reflux drug Protonix. The drug is named Pantoprazole Sodium Delayed-Release.
The drug will be available in both strengths of the brand, 20 and 40 mgs in bottles of 90.
“Our customers count on Teva for a continuous supply of new generic products,” stated John Denman, vice president of. Sales and Marketing. “With the launch of pantoprazole sodium delayed-release tablets we add another quality product to our broad line of affordable generic pharmaceuticals.
This launch comes just a day after Wyeth released their own generic version of the drug, in hopes of keeping some of the market share they would have lost due to generic competition. Near the end of this year, Teva and Sun Pharma had received approval to launch a generic version of Protonix.
The drug had sales of $2.5 billion in 2007, according to Wyeth.