Thursday, April 22, 2010

Lyrica (Pregabalin) Off-label Use Suicide and Attempted Suicide Lawsuits

Lyrica Off-label Use Suicide and Attempted Suicide Lawsuits
(by Pregabalin Off-label Use Suicide Lawyer Jason Coomer
Lyrica (Pregabalin) is a derivative of the drug Neurontin.  Nuerontin has been aggressively marketed for many off-label uses and Lyrica has been also.  Some of the off-label uses of the drugs include pain relief, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus.  The FDA has recently issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking pregabalin. 

Lyrica Approved Uses, FDA Actions, and FDA Warnings
(Pregabalin Suicide Lawsuits)

Lyrica (pregabalin) is a prescription medication approved for the treatment of the following conditions:
  • Diabetic peripheral neuropathy -- Lyrica is approved to be used for the treatment of nerve pain associated with Diabetic Peripheral Neuropathy
  • Epilepsy -- Lyrica is approved to be used with other medication for the treatment of seizures called partial seizures
  • Fibromyalgia -- Lyrica is approved to be used in the treatment of fibromyalgia pain
  • Postherpetic neuralgia -- Lyrica is approved to be used in the treatment of nerve pain that occurs after an outbreak of shingles.
The U.S. Food and Drug Administration (FDA) issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking antiepileptic drugs (AED) including Lyrica (pregabalin). An independent analysis by the FDA showed that anticonvulsant drugs, including pregabalin, can increase suicidal thoughts in patients. The approved label for Lyrica now includes a warning about an increased risk of suicidal thoughts or actions and a guide to help patients understand this risk.

Off-Label Marketing of Lyrica, Off-Label Criminal Penalties & Civil Fines Paid by Pfizer, and Off-Label Marketing Lawsuits

The Federal Food Drug and Cosmetic Act (”FDCA”), provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for one use only can also be prescribed by a physician for another use, known as “off-label.” 

Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. A manufacturer illegally “misbrands” a drug if the drug’s labeling includes information about its unapproved uses. A drug is deemed misbranded unless its labeling bears adequate directions for use. The courts have agreed with the FDA that the FDCA requires information not only on how a product is to be used (e.g. dosage and administration), but also on all the intended uses of the product. Oral statements and materials presented at industry-support scientific and educational activities may provide evidence of a product’s intended use. If these statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded under the FDCA for failure to bear labeling with adequate directions for all intended uses.

Lyrica is one of four drugs which a subsidiary of Pfizer in 2009 pleaded guilty to misbranding "with the intent to defraud or mislead". Pfizer agreed to pay $2.3 billion in settlement, and entered a corporate integrity agreement. Pfizer illegally promoted the drugs and caused false claims to be submitted to government healthcare programs for uses that were not medically accepted.  For more information on Off-Label Marketing Fraud, go to the following web page on Off-Label Marketing Fraud

Lyrica is basically a next generation drug of gabapentin.  As the patents ran out on gabapentin (brand name Neurontin), Pfizer altered the medication slightly and created Lyrica (Pregabalin).  Both drug have been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus.  This off-label marketing for Lyrica and Neurontin is a serious problem in that the FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking Neurotin. 

It is estimated that over 90 percent of Pfizer's revenue from Neurontin which is in the billions of dollars is from off-label use.  Pfizer has paid a total of $2.75 billion in off-label penalties since 2004 which is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.  (Pfizer Broke the Law by Promoting Drugs for Unapproved Uses)

Pfizer continues aggressively marketing Lyrica and is enjoying expanding sales of this product to about $3 Billion annually.  They continue to push for new approved uses through the FDA and were able to make Lyrica one of the first drugs approved for Fibromyalgia.  This drug is being pushed through television advertisements and doctors, despite dangerous side effects.  For more information on drug company aggressive marketing and pursuit of profits, go to the following web page: Economic Incentives for Drug Companies Lead to Aggressive Marketing of Defective & Ineffective Medications and Need for FDA Regulations, Checks on Drug Marketing, and Defective Drug Lawsuits

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior
for Antiepileptic Drugs AEDs 

In December 2008, the U.S. Food and Drug Administration announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy. 

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. 

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional." 

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed. 

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo. 

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs (AEDs) are required to add warnings about the risk of suicidality:
  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
  • Clonazepam (marketed as Klonopin)
  • Clorazepate (marketed as Tranxene)
  • Divalproex sodium (marketed as Depakote, Depakote ER)
  • Ethosuximide (marketed as Zarontin)
  • Ethotoin (marketed as Peganone)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Lacosamide (marketed as Vimpat)
  • Levetiracetam (marketed as Keppra)
  • Mephenytoin (marketed as Mesantoin)
  • Methosuximide (marketed as Celontin)
  • Oxcarbazepine (marketed as Trileptal)
  • Phenytoin (marketed as Dilantin)
  • Pregabalin (marketed as Lyrica)
  • Primidone (marketed as Mysoline)
  • Rufinamide (marketed as Banzel)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Trimethadione (marketed as Tridione)
  • Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
  • Zonisamide (marketed as Zonegran)
Neurontin and Lyrica Suicide Lawsuits (Gabapentin and Pregabalin Suicide Lawyers) 

In 2009, the first cases against Pfizer, the maker of Neurontin, began going to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.

In March 2010, a jury awarded $140 million in a Neurontin case.  Many more Neurontin cases are pending and are moving to trial.  Additionally, it is expected that Lyrica Suicide cases are going to filed in the near future and start going to trial in the future.

For more information on Neurontin (Gabapentin) and Lyrica (Pregabalin) Lawsuits, please go to the following web page on Lyrica (Pregabalin), Antiepileptic Drugs (AED), and Neurontin (Gabapentin) Suicide Lawsuits