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Lyrica Drug Lawsuit Source
Lyrica Lawsuits: Birth Defects

No Longer Accepting Cases For This Drug

Commonly asked questions about Lyrica (pregabalin):

What is Lyrica?

It is an anti-epileptic drug used to control seizures and to treat fibromyalgia, as well as generalized anxiety disorder (GDO).

Lyrica, which is often referred to as an anti-convulsant, is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia, or neuropathic pain associated with spinal cord injury.

The controversial drug essentially works by affecting chemicals in the brain that send pain signals across the nervous system. Developed by one of the world’s largest pharmaceutical companies, Pfizer, it was first approved by the U.S. Food and Drug Administration in December 2004.

The FDA approved generic versions in 2012 made by Lupin Pharmaceuticals, Teva Pharmaceuticals, and Watson Laboratories. However, generic versions of the drug are not yet available in the United States after a ruling in federal court in February 2014 upheld a lower court ruling that Pfizer’s patent for pregabalin remains valid through 2018.

Why Am I Being Prescribed Lyrica?

It is a prescription medicine used in adults, 18 years and older, to treat several different symptoms, including:

  • Management of neuropathic pain associated with diabetic peripheral neuropathy
  • Management of postherpetic neuralgia
  • Adjunctive therapy for adult patients with partial onset seizures
  • Management of fibromyalgia
  • Management of neuropathic pain associated with spinal cord injury

What Are The Possible Serious Side Effects of Lyrica?

According to the FDA, the drug may cause serious side effects, including:

  1. Serious, even life-threatening, allergic reactions
  2. Suicidal thoughts or actions
  3. Swelling of your hands, legs and feet
  4. Dizziness and sleepiness
  5. Muscle problems, muscle pain, soreness or weakness
  6. Problems with your eyesight, including blurry vision
  7. Weight gain
  8. Feeling “high”

These serious side effects are described below:

  1. Serious, even life-threatening, allergic reactions:
    • Stop taking Lyrica and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:
      • Swelling of your face, mouth, lips, gums, tongue, throat or neck.
      • Trouble breathing.
      • Rash, hives (raised bumps) or blisters

     

  2. Lyrica may cause suicidal thoughts or actions in a very small number of people, about 1 in 500, according to the FDA.
    • Call a healthcare provider right away if you  have any of these symptoms, especially if they are new, worse or worry you:
      • Thoughts about suicide or dying
      • Attempts to commit suicide
      • New or worse depression
      • New or worse anxiety
      • Feeling agitated or restless
      • Panic attacks
      • Trouble sleeping (insomnia)
      • New or worse irritability
      • Acting aggressive, being angry or violent
      • Acting on dangerous impulses
      • An extreme increase in activity or talking (mania)
      • Other unusual changes in behavior or mood

       

    • If you have suicidal thoughts or actions, do not stop Lyrica without first talking to a healthcare provider.
      • Stopping Lyrica suddenly can cause serious problems.
      • Suicidal thoughts or actions can be causes by things other than medicines. if you have suicidal thoughts or actions, your healthcare provider may check for other causes.

       

    • How can I watch for early symptoms of suicidal thoughts and actions?
      • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings.
      • Keep all follow-up visits with your healthcare provider as scheduled.
      • Call your  healthcare provider between visits as needed, especially if you are worried about symptoms.

     

  3. Swelling of your hands, legs and feet
    • This swelling can be a serious problem for people with heart problems.

     

  4. Dizziness and sleepiness
    • Do not drive a car, work with machines or do other dangerous activities until you know how Lyrica affects you. Ask your healthcare provider about when it will be OK to do these activities.

     

  5. Muscle problems, muscle pain, soreness or weakness
    • If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away

     

  6. Problems with your eyesight, including blurry vision
    • Call your healthcare provider if you have eany changes in your eyesight

     

  7. Weight gain
    • If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.

     

  8. Feeling “high”
    1. The Drug Enforcement Administration (DEA) classifies Lyrica as a Schedule V drug. This class of drugs have “lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics,” according to the DEA official website.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions, ask your healthcare provider or pharmacist.

What Are Some Other Common Side Effects?

  • Sleepiness
  • Trouble concentrating
  • Dry mouth

It also caused skin sores in animal studies, according to the FDA. Skin sores did not happen in studies in people.

If you have diabetes, you should pay attention to your skin while taking the drug, and tell your healthcare provider about any sores or skin problems.

Can Lyrica Cause Birth Defects?

A recent study published in May 2016 suggested that users were three times more likely to give birth to babies with major congenital defects, compared to women in the control group.

According to a study published in the official Journal of the American Academy of Neurology, approximately six percent of pregnancies that involved the use of Lyrica resulted in defects, compared to two percent in women who didn’t take the drug.

The study reported that malformations associated with the drug included heart defects and structural problems with the central nervous system (CNS) or other organs. Women who took the controversial drug were reportedly six times more likely to have a pregnancy that resulted in a major nervous system defect, according to the published study.

Neurology: Data were collected from 164 exposed pregnancies and 656 controls. A significantly high major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with expposure during first trimester of pregnancy were analyzed separately (7/116 (6.0%] vs 12/580 [2.1%]; odds ratio 3.0, 95% confidence interval 1.2-7.9, p = 0.03.).

Can Lyrica Cause Weight Gain?

It may increase your appetite, which would lead to weight gain. You may have to change your eating habits.

In all clinical studies lasting up to 14 weeks, nine percent of patients who were taking it gained weight, compared with 2 percent of patients taking a placebo, according to the drug’s official website. These patients gained 7% or more from their starting weight.

What are The Withdrawal Symptoms If I Stop Taking Lyrica?

If you have a seizure disorder, you could experience more frequent seizures if you abruptly stop taking the drug, according to EverydayHealth.com.

Other Lyrica withdrawal symptoms include:

  • Headache
  • Nausea, diarrhea, and vomiting
  • Insomnia and nightmares
  • Irritability
  • Tingling sensations

Can I File A Lyrica Lawsuit?

Our dangerous drug lawyers can help if you or someone you care about gave birth to a baby with a major congenital defects. Our top-rated lawyers are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.

Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed.

Our No-Fee Promise

You can afford to have our great team of lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls are always free

How Do I Start A Claim?

Our drug lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-4722 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have a claim, we will start immediately.

WARNING: There are strict time deadlines for filing lawsuit claims.


Lyrica News – Lawsuits, Settlements, Information

View Sources

  1. Lyrica Medication Guide – U.S. Food and Drug Administration
  2. Lyrica (pregabalin) – Official Website
  3. Lyrica: Full Prescribing Information – Pfizer

References