US orders suicidal action warning on epilepsy drugs Dec 18, 2008
Manufacturers also need to develop pamphlets to alert patients to the risks of the medicines, which include Pfizer Inc's (PFE.N: , , ) Lyrica and Neurontin, GlaxoSmithKline PLC's (GSK.L: , , ) Lamictal and Johnson & Johnson's (JNJ.N: , , ) Topamax. The FDA action followed recommendations from a panel of outside experts who met in July. (Reuters)
FDA Adds Suicide Warning to Epilepsy Drugs Dec 18, 2008
In addition to clonazepam, phenytoin and topiramate, the drugs covered by the new FDA-mandated labeling are: carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal);... (MEDLINEplus)
Epilepsy drugs to warn of suicide risk Dec 17, 2008
said its Lyrica and Neurontin pills were safe and that it was unfair to combine data for medicines that work differently. "The risk of suicidal thoughts or behavior was generally consistent among the 11 drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions," the FDA said. (Boston Globe)
FDA orders epilepsy drug suicide warning Dec 17, 2008
Pfizer said it would work with FDA to update labeling on Lyrica and Neurontin, an older drug which is approved to treat both epilepsy and nerve pain. Pfizer hopes that the labeling change will further facilitate important dialogue that should always occur between patients and their doctors. (MSNBC -- Health)
Headaches & Migraines Dec 10, 2008
Gabapentin (Neurontin), another anti-seizure medication, is considered a second-line treatment agent. In high doses, however, these anti-seizure drugs may cause side effects, such as nausea and vomiting, diarrhea, cramps, hair loss and dizziness. (CNN -- Health)
Generic heart medicines found equal to brand-name counterparts Dec 3, 2008
The program was set up as part of a settlement between Pfizer and state attorneys general over marketing of the epilepsy treatment Neurontin. The researchers have also received awards from federal agencies. (Honolulu Advertiser)
Teva Grabs Billions Flouting Drug Patents on Brand Names by Pfizer, Sanofi Dec 2, 2008
Teva joined with to copy Neurontin, an epilepsy drug from New York-based , in 2004, and with Barr to copy the original formulation of Allegra in 2005. Allegra-D is an extended-release version with a decongestant added. (Bloomberg)
Strengthen Restrictions On Off-label Promotion By Pharmaceutical Companies, Researchers Urge Oct 31, 2008
PharmedOut is funded through the Attorney General Consumer and Prescriber Education grant program, created as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, Inc., and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin (gabapentin) that violated state consumer protection laws. Fugh-Berman has been a paid expert witness on the plaintiff's side in... (Science Daily)
Life with breast cancer: Head-to-toe truths Oct 17, 2008
"But there is some research on the benefits of B6 vitamins for numbness. And patients can manage pain with Neurontin.". Women also sometimes get brittle nails on fingers and toes from chemo and burns from radiation. (CNN -- Health)
A light in the darkness Oct 16, 2008
She is currently taking Clorazapam, and Lorazepam, both anti-anxiety drugs; Neurontin, an anticonvulsant; and Geodon, an anti-psychotic drug used to treat bipolar disorder. I would end the marriage and walk out because I always thought there was something greener. (Klamath Falls Herald & News, OR)
Pfizer `Spun' Unfavorable Neurontin Drug Studies, Experts Say Oct 10, 2008
Pfizer `Spun' Neurontin Study Results, Experts Say (Update1) ... Oct. 8 (Bloomberg) -- ``spun'' medical studies that undermined the drugmaker's campaign to expand sales of its Neurontin epilepsy treatment, according to experts hired by plaintiffs suing the company for fraud ... In documents filed yesterday in federal court in Boston, the experts said Pfizer had a ``publication strategy'' to suppress negative reports in medical journals while promoting ``off-label'' uses for Neurontin that... (Bloomberg)
Experts Conclude Pfizer Manipulated Studies Oct 8, 2008
The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company ... One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents... (Atlanta Journal-Constitution -- Health)
Dow: How Low Can You Go? Oct 8, 2008
According to internal company e-mails submitted in a lawsuit, suggesting "their blockbuster medication Neurontin was ineffective for chronic nerve pain," reports the Boston Globe. Back in 2004, the drug company's that it "promoted Neurontin for uses not approved by the Food and Drug Administration, including bipolar disorder and chronic nerve pain," notes the WSJ. This new case consolidates lawsuits by health insurers and consumers who claim they were misled into purchasing Neurontin and want a... (Slate)
Suicide risks studied in drugs for physical ills Aug 31, 2008
In February 2004, he began taking Neurontin, an epilepsy drug also prescribed for nerve-related pain and used for chronic back trouble ... They did not connect the changes to Neurontin ... Pfizer Inc., which makes Neurontin, said that since the drug was first marketed in the 1990s, the prescribing literature had listed "suicidal" and "suicidal gesture" as rarely reported adverse events seen in clinical trials. (Florida Times-Union)
Anticonvulsants, CFS/ME and FM Aug 26, 2008
Pregabalin (Lyrica), gabapentin (Neurontin) and other anticonvulsants are used to treat chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and fibromyalgia ... Gabapentin (Neurontin). (Suite101.com)
Epilepsy drug may help alcoholics recover from dependence, small study suggests Aug 4, 2008
The study was funded by the National Institutes of Health, and the study medication was provided by Parke-Davis (now Pfizer), which markets gabapentin as Neurontin. In addition to Brower and Consens, the study's authors include Hyungjin Myra Kim, Stephen Strobbe, Maher Karam-Hage and senior author Robert Zucker. (EurekAlert!)
first reported Jul 15, 2008
Late last year, Ranbaxy voluntarily recalled 73 million doses of a generic version of the pain pill Neurontin. Charles Caprariello, a spokesman for Ranbaxy, whose U.S. operations are based in Plainsboro, confirmed the federal investigation. (NJ.com -- News)
FDA Decides on Epilepsy Drug Situation Jul 14, 2008
The list of drugs the FDA has been keeping an eye on contains the following names: Carbamazepine (aka Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate (aka Felbatol), Gabapentin (aka Neurontin), Lamotrigine (aka Lamictal), Levetiracetam (aka Keppra), Oxcarbazepine (aka Trileptal), Pregabalin (aka Lyrica), Tiagabine (aka Gabitril), Topiramate (aka Topamax), Valproate (aka Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (aka Zonegran). These types of drugs are usually used for... (eFluxMedia)
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs Jul 13, 2008
The drugs reviewed by the FDA were: 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) and Zonisamide (marketed as Zonegran). Some of... (MEDLINEplus)
Epilepsy drugs may require strictest warning Jul 8, 2008
Additional products included in the FDA's review are Neurontin and Lyrica, Meda AB's Felbatol, UCB SA's Keppra, AG's Trileptal, Gabitril, Depakote, Eisai Co.'s Zonegran, and carbamazepine, sold by several drug makers. The FDA found that risks varied for each drug and were statistically significant only for Topamax and Lamictal. (Boston Globe)
Prescription for disaster: drugs, lies, and greed Jun 8, 2008
Franklin's job was to increase sales of Neurontin, a drug approved to treat epilepsy in limited cases ... Company executives, not satisfied with selling Neurontin for its limited approved use, marketed it for a dozen other, unrelated conditions for which it had not been tested, among them attention deficit disorder, sexual dysfunction, manic depression, and - bizarrely - chronic hiccups ... Concluded a physician at the National Institute of Mental Health after taking a close look at the drug,... (Boston Globe)
Drug, device firms agree to more public scrutiny of spending Apr 11, 2008
The committee report noted that Warner-Lambert, now owned by Pfizer Inc., paid $430-million to settle claims that medical conferences it sponsored were used to illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704-million to settle a similar claim concerning the AIDS drug Serostim. (Globe and Mail -- Business)
Drug Companies on the Hook for Off-Label Use of Generic Mar 22, 2008
The plaintiffs in the class action allege that the drug company defendants conducted a campaign to promote the prescription of its Neurontin drug and its generic equivalent, gabapentin, for a number of medical uses not approved by the FDA, according to court papers ... It was foreseeable that the marketing of Neurontin for off-label use would increase the demand for the generic version of the drug, Bernstein said ... The defendants themselves estimated that Neurontin would lose 65 to 95 percent... (Law.com)
FDA warnings loud but ineffective with docs: experts Feb 27, 2008
It also warned of increased suicide risk in anti-epileptic drugs like Lyrica and Neurontin from Pfizer (, ) and Topamax from Johnson & Johnson (, ), as well as Pfizer's anti-smoking drug Chantix. Last year, the FDA strengthened its warnings for diabetes drugs Avandia from GlaxoSmithKline () and Takeda's Actos. (Yahoo News -- Consumer News)
FDA Proposed Off-Label Marketing Rule Changes Will Hurt Consumers ... Feb 19, 2008
For instance, Pfizer Inc. settled a case about the epilepsy drug Neurontin in 2004 for $430 million. In another high-profile case, Eli Lilly is said to be in negotiations with the Justice Department over illegal marketing of Zyprexa. (Newsinferno.com)
FDA seeks to allow a broader range of uses for drugs Feb 18, 2008
In 2004, Pfizer paid a $430 million fine to resolve criminal and civil charges that it marketed its epilepsy drug Neurontin for conditions in which the company's own studies suggested that the drug was ineffective. The FDA has for years struggled to find the appropriate balance between the need to inform doctors of experimental but hopeful drug and device uses and the need to guard against hucksters promoting dangerous products as cure-alls. (International Herald Tribune -- Business)
FDA drug warning comes as trial nears Feb 14, 2008
Until his wife took a drug called Neurontin, James Presley never recalled Carol Presley being depressed or having suicidal thoughts in their 21 years of marriage ... Last month, the U.S. Food and Drug Administration released a warning that Neurontin and 10 other anti-epilepsy drugs increased the risk of suicidal thoughts and behaviors ... Attorney Andrew Finkelstein, of Finkelstein and Partners in Newburgh, Orange County, represents the Presleys and 350 families of people who killed themselves... (Albany Times Union)
Mis-typed label led to husband's death; hear audio Feb 14, 2008
He had tried prescriptions for the painkillers Neurontin and Oxycontin. But, as he told his wife, Pearl, he didn't like the drowsiness they brought on. (USA Today -- Money)
FDA warns on epilepsy drug, risk of suicide Feb 1, 2008
It analyzed data from 11 well-known antiseizure drugs, including Neurontin, AG's Tegretol, and Depakote - but the FDA said it expected the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels. (Boston Globe)
Doctors warned about epilepsy drugs' risks Feb 1, 2008
It might also increase the legal woes of Pfizer Inc., which faces hundreds of lawsuits claiming its drug Neurontin caused suicides and suicide attempts. Drug regulators reviewed data from 199 clinical trials on anti-epilepsy medications, including Pfizer's drugs Neurontin and Lyrica, Topamax from Ortho-MacNeil Pharmaceutical, and Abbott Laboratories' Depakote ... While the warnings may have a similar effect on future sales for all manufacturers, the FDA's conclusions may contribute to Pfizer's... (San Francisco Chronicle -- Business)
After an aching loss, a healing gift Dec 25, 2007
In the meantime, there was Neurontin, Tegretol, Topamax, Keppra and Dilantin. The drugs sometimes made him sleepy or irritable, and the migraine headaches were brutal. (AZCentral -- News)
Generic antidepressant may affect Wyeth Dec 21, 2007
In 2004, Ivax Corp. began selling tablet versions of Pfizer's Neurontin capsules for epilepsy, causing an immediate slowdown in the growth of Neurontin's sales, to 10 percent for the quarter in which Ivax launched from 32 percent in the preceding quarter. Ivax is now part of Teva Pharmaceutical Industries Ltd.. (Herald Online, SC -- Health)
Gabapentin May Help Alcoholics Maintain Abstinence Dec 19, 2007
Gabapentin, commonly known by the trade names Neurontin or Gabarone, is an anti-seizure drug frequently prescribed for epilepsy. The drug is also used to treat persistent neurological pain. (MEDLINEplus)
Choose with caution: Drug plans more expensive next year Dec 10, 2007
Another pitfall in her plan this year: It stopped covering Neurontin, a drug she needs for her legs and feet to help her remain mobile, Stewart said. Her plan covers a generic substitute, but she tried it and quit because of a weight gain side effect she can ill afford as a diabetic, she said. (Urbana/Champaign News-Gazette)
Surviving An Epilepsy Diagnosis Nov 28, 2007
Gabapentin (Neurontin). Phenytoin (Dilantin). (Suite101.com)
* Drugs and more can ease chronic pain Nov 27, 2007
Several classes of drugs originally marketed for other uses are now part of the pain control armamentarium - antidepressants, especially the Serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine (Effexor) and duloxetine (Cymbalta); anti-epileptics like gabapentin (Neurontin) and pregabalin (Lyrica); and muscle relaxants like baclofen (Lioresal) and dantrolene sodium (Dantrium). These are often used in combination with specific pain-relieving drugs. (Taipei Times, Taiwan -- World)
Many treatments can ease chronic pain Nov 21, 2007
Several classes of drugs originally marketed for other uses are now part of the pain control armamentarium antidepressants, especially the S.N.R.I.'s like venlafaxine (Effexor) and duloxetine (Cymbalta); antiepileptics like gabapentin (Neurontin) and pregabalin (Lyrica); and muscle relaxants like baclofen (Lioresal) and dantrolene sodium (Dantrium). These are often used in combination with specific pain-relieving drugs. (International Herald Tribune -- Health)
Woman charged with selling prescriptions Nov 10, 2007
Deputies served a search warrant at Vanwinkle's home on the 500 block of San Emidio on Oct. 26 and seized sixty hypodermic syringes, the prescription drugs Seroquil, Lininopril, Neurontin, psuedoephedrine and a large quantity of unknown pills and medications, Downs said. Comments. (Taft Daily Midway Driller, CA)
Drugstore giant fights lawsuits alleging fatal prescriptions Nov 2, 2007
Plagued by neuropathy, a disorder of the peripheral nerves that caused pain in his legs and back, Pearl Smith's husband had been taking prescriptions for OxyContin and Neurontin, she said. But he didn't like the way the drugs made him feel, such as the way he'd sometimes "drop out" in the middle of a conversation. (USA Today -- Money)
Bristol-Myers Squibb to Settle Probes Sep 29, 2007
In 2004, Pfizer Inc. paid $430 million in fines to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses. In 2001, TAP Pharmaceutical Products paid $875 million to settle allegations it inflated prices and bribed doctors to prescribe its prostate cancer drug Lupron. (Atlanta Journal-Constitution -- Business)
Phil Spector case ends in mistrial Sep 27, 2007
With this taken on top of his medication - Prozac, Neurontin and tetracycline - Spector, the prosecution argued, was out of control. His night ended at the House of Blues, where he met Clarkson, recently begun there as a hostess. (Guardian Unlimited)
Stocks to watch on Tuesday Sep 25, 2007
Pfizers shares will be buzzing after a US court reversed an earlier ruling that allowed companies to market the generic copies of Neurontin, Pfizers brand name for gabapentin. The Pfizer share closed up 0. (India Times)
Court rules for Pfizer in Neurontin patent infringement case Sep 22, 2007
LONDON (Thomson Financial) - Pfizer Inc said that an appeals court has overturned a lower court ruling that several generic manufacturers did not infringe the company's patent for stabilized formulations of gabapentin, the active ingredient in Neurontin ... Pfizer said the ruling will allow the company to seek a judgment of infringement and, if successful, pursue full compensation for the damages it suffered due to the 2004 at-risk launch of generic versions of Neurontin ... Prior to such... (Forbes -- Markets)
Are drug companies calling the shots? Sep 6, 2007
It came from Pfizer's $430 million settlement for marketing epilepsy drug Neurontin for unapproved uses. The initiative includes a four-part documentary showing doctors how the industry goes about obtaining their patients' business, produced by former drug sales rep Kathleen Slattery-Moschkau. (The Daily Reflector)
Bipolar Diagnosis in Kids Jumps 40-Fold in 10 Years (Update3) Sep 5, 2007
Drugs in this group include Depakote made by Abbott Laboratories; Johnson & Johnson's Topomax; GlaxoSmithKline Plc's Lamictal; Novartis AG's Tegretol and Pfizer Inc.'s Lyrica and Neurontin. None are approved by U.S. regulators for treating children with bipolar disorder. (Bloomberg)
Fla. Medicaid Dispute Addresses States' Control of Drug Coverage Rules Aug 24, 2007
In February 2006, the late U.S. Magistrate Judge Theodore Klein ruled the Florida Agency for Health Care Administration violated federal Medicaid law by barring coverage of most non-FDA-approved uses for the drug Neurontin and its generic gabapentin that are listed in the compendia ... Private and legal aid lawyers for the plaintiffs say the state now is complying with Klein's ruling and covering non-FDA-approved uses of Neurontin and its generic version ... Miriam Harmatz, a staff attorney with... (Law.com)
Witness Denies She Said Spector Should Fry Jul 19, 2007
Clarkson was found to have taken Vicodin, a painkiller, and Spector had three drugs: the antidepressant Prozac and the anti-seizure medications Topamax and Neurontin. Robert Alan Middleberg, a forensic toxicologist from Willow Grove, Pa. (CBS News -- Early Show)
Teva Announces Tentative Approval of Famciclovir Tablets Jun 28, 2007
Important factors that could cause or contribute to such differences include risks relating to: Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to... (BusinessWire)
Mass. health providers object to drug store clinics Jun 18, 2007
Neurontin fines fund program on drug industry influence ... Both are funded through fines paid by the drug giant Pfizer in 2004 when its Warner-Lambert subsidiary pleaded guilty to promoting unapproved uses for the anti-seizure drug Neurontin. (Boston Globe)
Depomed starts clinical test for hot flash drug Jun 14, 2007
It is sold under the brand name Neurontin by a unit of New York drug giant (NYSE: PFE). This new, extended-release formulation of the drug is being tested in 108 menopausal women at 10 sites in the United States and Canada. (San Francisco Business Journal)
Nonhormonal drug reduces hot flashes in men treated for prostate cancer Jun 4, 2007
Gabapentin (trade name Neurontin) was approved by the Food and Drug Administration () to treat epileptic seizures in 1994, and pain from shingles in 2002. The ability of gabapentin to reduce hot flashes was first detected when it was being used for other reasons. (EurekAlert!)
Probing Doctor And Industry Ties Apr 27, 2007
This was set up in 2004 as part of a settlement between a division of the drug company Pfizer (Warner-Lambert) and the Attorneys General of 50 US states and the District of Columbia, who accused the drug company of marketing the drug Neurontin (gabapentin) in violation of state consumer protection laws. The article describes in great detail the type of training that a drug rep goes through to learn how to change the prescribing behaviour of the doctors in their sales territory. (Medical News Today)
Posing As Pals, Drug Reps Sway Doctors' Choices Apr 26, 2007
Tuesday, April 24, 2007. By Julie Steenhuysen. (MEDLINEplus)
Drug Company Sales Visits Influenced Doctors, Study Finds Apr 25, 2007
The lawsuit was brought by a former employee who alleged that the company promoted gabapentin, which it sold under the name Neurontin, for uses not officially approved by the FDA.. "To me, the remarkable thing is how effective a very brief visit by a drug representative ---- most often less than five minutes ---- can be in influencing physicians' choices to use a drug for an unapproved indication," Bero said. (Science Daily)
Friendly drug reps sway doctors choices Apr 24, 2007
The study analyzed surveys done by a market research firm that chronicled a doctors intention to prescribe the epilepsy drug gabapentin during the period of 1995 to 1999, when it was sold by Warner-Lambert under the brand name Neurontin. Pfizer Inc., which acquired that unit in 2000, paid a $240 million fine four years later for illegal promotion of the drug for unapproved uses such as migraines or pain. (MSNBC -- Health)
High court rejects case on Lipitor's patent term Apr 3, 2007
Pfizer has lost patent protection on a succession of products including the epilepsy drug Neurontin, the antibiotic Zithromax and the antidepressant Zoloft. On March 22, a federal appeals court invalidated the drugmaker's patent on Norvasc, a hypertension drug. (Sunspot.net -- Business)
Non-Hormone Drug Decreases Hot Flashes Mar 1, 2007
The drug is the active ingredient in Neurontin, which is most commonly used to treat nerve pain and other neurological conditions, but it has been shown to have some effect on hot flashes. The physicians investigated whether it's better to give gabapentin alone or with the antidepressant by having half the participants continue on their antidepressant therapy while taking gabapentin. (MEDLINEplus)
Pfizer's New Blockbuster Drug Jan 23, 2007
Lyrica, an improved version of the off-patent Neurontin, was initially delayed for several years at the U.S. Food and Drug Administration ... In 2004, Pfizer paid $430 million to settle allegations that it had marketed Neurontin for unapproved uses. (Forbes)
Dear Pharmacist Jan 23, 2007
Neurologists often use anti-epileptic drugs such as Tegretol (carbamazepine), Neurontin (gabapentin) and Dilantin (phenytoin), among others. Baclofen and Zanaflex are other considerations. (Shoals TimesDaily)
Peripheral neuropathy; eating peanuts in the shell Jan 16, 2007
He is on lorazepam and Neurontin. He still has pain. (Herald-Tribune)
