Neurontin Suicides: FDA Still Turning A Deaf Ear Charges Rep Hinchey
CategoriesMaurice Hinchey, Representative of the 22nd Congressional District of New York is calling for a thorough examination of the link between Neurontin, an anti-epilepsy drug that has been made a block-buster seller by off-label marketing, and suicides. The lawmaker blasted the FDA's failure to act in this matter in a letter to FDA acting Commissioner Lester Crawford dated 7 September 2004.
According to a report by the Alliance for Human Research Protection, Andrew Finkelstein, of the New York Law firm Finkelstein & Partners "knew of 160 Americans who, having never attempted any form of suicide before taking Neurontin, committed suicide while on the drug, as well as over two thousand (2,000) Americans who, having never attempted suicide before taking Neurontin, were hospitalized following a suicide attempt while on the drug."
One would think that 160 deaths and two thousand attempted suicides should lead to immediate action on the part of the FDA. Not so, as a matter of fact Teva Pharmaceuticals received FDA approval for its launch of a generic versions of the Neurontin, also known as gabapentin.
The drug, which apparently nets Pfizer 1.7 billion $ a year, was originally approved only for epilepsy, but was illegally promoted by Warner Lambert's Parke Davis for other, non-approved uses. According to an article in the San Francisco Gate:
Prosecutors in the case said Warner-Lambert turned Neurontin into a blockbuster drug with tactics like paying doctors to listen to pitches for unapproved uses and treating them to luxury trips to Hawaii, Florida or the 1996 Olympics in Atlanta. One doctor received almost $308,000 to tout Neurontin at conferences. "This illegal and fraudulent promotion scheme corrupted the information process relied on by doctors in their medical decision making, thereby putting patients at risk,'' said U.S. Attorney Michael Sullivan, chief prosecutor for the federal district based in Boston.While Pfizer had to pay more than 400 million $ to settle the suit over its illegal promotion of the drug, it would appear that the suicide allegations clearly warrant serious investigation, but for now, the FDA is going in the opposite direction - the agency has been intervening in liability lawsuits in defense of drug companies and medical device manufacturers sued by individuals who have been harmed.
Neurontin safety
It may be instructive to look at Pfizer's product warnings on Neurontin:
WARNINGS
Neuropsychiatric Adverse Events—Pediatric Patients 3-12 years of ageGabapentin use in pediatric patients with epilepsy 3–12 years of age is associated with the occurrence of central nervous system related adverse events. The most significant of these can be classified into the following categories:
1) emotional lability (primarily behavioral problems),
2) hostility, including aggressive behaviors,
3) thought disorder, including concentration problems and change in school performance, and
4) hyperkinesia (primarily restlessness and hyperactivity).Among the gabapentin-treated patients, most of the events were mild to moderate
in intensity. In controlled trials in pediatric patients 3–12 years of age the incidence of these adverse events was: emotional lability 6% (gabapentin-treated patients) vs 1.3% (placebo-treated patients); hostility 5.2% vs 1.3%; hyperkinesia 4.7% vs 2.9%; and thought disorder 1.7% vs 0%. One of these events, a report of hostility, was considered serious. Discontinuation of gabapentin treatment occurred in 1.3% of patients reporting emotional lability and hyperkinesia and 0.9% of gabapentin-treated patients reporting hostility and thought disorder. One placebo-treated patient (0.4%) withdrew due to emotional lability.Withdrawal Precipitated Seizure, Status Epilepticus
Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.
In the placebo-controlled studies in patients >12 years of age, the incidence of status epilepticus in patients receiving Neurontin® was 0.6% (3 of 543) versus 0.5% in patients receiving placebo (2 of 378). Among the 2074 patients >12 years of age treated with Neurontin® across all studies (controlled and uncontrolled) 31 (1.5%) had status epilepticus. Of these, 14 patients had no prior history of status epilepticus either before treatment or while on other medications. Because adequate historical data are not available, it is impossible to say whether or not treatment with Neurontin® is associated with a higher or lower rate of status epilepticus than would be expected
to occur in a similar population not treated with Neurontin®.Tumorigenic Potential
In standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female, rats. (See PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility.) The clinical significance of this finding is unknown. Clinical experience during gabapentin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans.
In clinical studies in adjunctive therapy in epilepsy comprising 2085 patient-years of exposure in patients >12 years of age, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung, 1 adrenal, 1 non-Hodgkin’s lymphoma, 1 endometrial carcinoma in situ), and preexisting tumors worsened in 11 patients (9 brain, 1 breast, 1 prostate) during or up to 2 years following discontinuation of Neurontin®. Without knowledge of the background incidence and recurrence in a similar population not treated with Neurontin®, it is impossible to know whether the incidence seen in this cohort is or is not affected by treatment.
Sudden and Unexplained Death in Patients With Epilepsy
During the course of premarketing development of Neurontin® 8 sudden and unexplained deaths were recorded among a cohort of 2203 patients treated (2103 patient-years of exposure). Some of these could represent seizure-related deaths in which the seizure was not observed, e.g., at night. This represents an incidence of 0.0038 deaths per patient-year. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving Neurontin® (ranging from 0.0005 for the general population of epileptics to 0.003 for a clinical trial population similar to that in the Neurontin® program, to 0.005 for patients with refractory epilepsy). Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the Neurontin® cohort and the accuracy of the estimates provided.
Documents and related articles:Neurontin - HARD SELL
How Marketing Drives the Pharmaceutical IndustryMaurice Hinchey's letter to FDA Commissioner Crawford
Alliance for Human Research Protection: Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy
FDA requests anticonvulsants be reexamined
The Food and Drug Administration has asked the makers of epilepsy drugs, which are the fifth best-selling group of medications and are taken by millions of Americans, to reexamine their data to determine if the drugs increase patients' risk of suicide.Pharma: Tame Watchdogs Not Protecting Public Health
FDA Covers Up Report - Mosholder: 'Antidepressants Double Suicides in Children'
Pfizer Sued in California: Covering up Zoloft Side Effects
Over-enthusiastic off-label prescribing of gabapentin
posted by Sepp Hasslberger on Monday October 11 2004
updated on Thursday October 6 2005URL of this article:
http://www.newmediaexplorer.org/sepp/2004/10/11/neurontin_suicides_fda_still_turning_a_deaf_ear_charges_rep_hinchey.htm
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