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"LYRICA Side Effects Lawsuit"
Lyrica has been linked to reduced brain functioning, psychiatric side effects, including suicidal behavior, withdrawal symptoms, and rare but serious allergic reactions. The FDA approved the drug, known by its generic name pregabalin, in 2004 as a treatment for epilepsy, neuropathic pain in diabetics, spinal cord injury, and severe neuralgia caused by herpes zoster.
Expand text.. In 2007, the FDA allowed Pfizer to market Lyrica as a medication for fibromyalgia rheumatoid disorders. The anticonvulsant drug slows down the brain impulses responsible for seizures.
In 2009, Pfizer admitted that it had illegally promoted Lyrica and three other drugs with false claims and misbranded them "with the intent to defraud." Lyrica impacts the whole body adversely and create digestive, nervous, and respiratory disorders. Patients using the drug are likely to suffer from lack of strength, breathing problem, muscle coordination problems, and accidental injury. The product label on Lyrica also carries warnings for suicidal behavior, angioedema or head, neck and throat swelling, respiratory emergency of the highest degree, increase in seizures, withdrawal problems, neurological disorders, risk of tumors, and allergies. The drug can worsen conditions of patients with heart problem, diabetes, kidney impairment, and alcohol addiction.
Lyrica FDA Alerts/ Warnings
In August 2011, the FDA alerted consumers about painful gynecomastia and breast enlargement in male due to Lyrica side effects.
In June 2011, the FDA ordered for label changes on Lyrica to include a medication guide, explaining detail side effects of the drug.
In June 2010, the FDA warned Pfizer for failing to report adverse events involving Lyrica.
In April 2009, they added label changes on the drug to include a warning on suicidal behavior and ideation. It even alerted consumers and doctors that the drug can worsen depression symptoms.
In December 2009, the FDA denied Pfizer’s permission to market the drug as a single medication for generalized anxiety disorder citing insufficient safety studies.
Detailed Lyrica Side Effects:
Nervous System Side Effects:
Lyrica impacts the functioning of the nervous system by inhibiting certain chemicals responsible for communication between the brain and nerves. Patients experience dizziness, confusion, drowsiness, muscle coordination problem or ataxia, muscle spasm, somnolence, and anxiety. The drug has also been linked to hypertonia, vision problems, cerebellar syndrome, speech disorder, circumoral paresthesia, eyeball movement disorder, schizophrenic reaction, Guillain-Barre syndrome, and neuralgia.
Psychiatric Side Effects:
Lyrica blocks normal brain functioning, which puts patients at the risk of abnormal thinking, feeling of distress and disbelief, agitation, mood changes, apathy, abnormal dreaming, and depersonalization. The drug also causes addiction, manic reaction, paranoid reaction, and psychotic depression.
Metabolic Side Effects:
Lyrica causes metabolic side effects, including edema, reduced glucose tolerance, uric acid crystal formation, hypoglycemia, and weight gain.
Gastrointestinal Side Effects:
Lyrica has been linked to a number of gastrointestinal side effects. Patients taking the drug therapy are likely to suffer from constipation, abdominal pain, nausea, excessive gas in the alimentary canal, gall bladder inflammation, gastrointestinal hemorrhage, gastritis, colitis, and dysphagia. The post-marketing reviews have also named mouth ulcers, pancreatitis, rectal hemorrhage, bilestones, stomatitis, esophageal ulceration, and tongue edema among other side effects of the drug.
Ocular Side Effects:
Lyrica side effects result in blurred vision, conjunctivitis, and diplopia in consumers. The drug has frequently been linked to visual field changes, night blindness, dry eyes, corneal ulcer, keratitis, eye hemorrhage, photophobia, and retinal vascular disorder.
Cardiovascular Side Effects
Peripheral edema, heart failure, and deep thrombophlebitis have been reported in patients treated with Lyrica therapy. The drug side effects have also been linked to hypotension and syncope in patients. Those with heart problems are likely to suffer from congestive heart failure.
Hypersensitivity and Allergy
Lyrica side effects may lead to angioedema and its symptoms, including swelling of the face, throat, tongue, and lips. The disease can create life-threatening respiratory problems requiring urgent medication. The drug also causes other hypersensitivity side effects, such as hives, skin, rashes, and blisters.
Respiratory Side Effects
Lyrica users are at the risk of suffering from respiratory side effects, including labored respiration, apnea, bronchitis, lung edema and fibrosis, laryngeal spasm, and atelectasis.
Musculoskeletal Side Effects
The drug has been linked to muscle spasm, weakness, cramps, back pain, and joint pain. The FDA has also received rare reports of generalized spasm and frequent complaints of arthrosis.
Oncologic Side Effects
Researchers have discovered that Lyrica creates new tumors and adds to the worsening of preexisting ones. It was found during animal studies that the drug side effects caused surprisingly high incidence of metastatic blood cancer hemangiosarcoma.
Dermatologic Side Effects
Lyrica causes skin ulcer, rash, pruritus, eczema, dermatitis, alopecia, and other dermatologic side effects. The post-marketing reports have also mentioned Stevens-Johnson syndrome and skin necrosis in patients being treated with the drug.
Other Lyrica Side Effects
Other documented side effects of the drug include amenorrhea, kidney failure, bladder neoplasm, abnormal ejaculation, nephritis, and uterine cervix inflammation.
Pfizer is facing a number of Lyrica lawsuits alleging wrong marketing practices, safety issues, and adverse side effects leading to serious injuries. In June 2010, Blue Cross Blue Shield, a Texas health insurance company, filed a lawsuit in the Eastern District federal court, alleging that Pfizer provided misleading information on the safety of Lyrica and three other drugs and encouraged off-label uses. The lawsuit came after Pfizer pleaded guilty of wrongful market practices to promote these drugs and agreed to pay $2.3 billion, including $1.2 billion in punitive damages, to settle lawsuits with the Justice Department in September 2009. Pfizer is also facing a number of lawsuits for the side effects of its antiepileptic drug Neurontin, anti-inflammatory drug Bextra, antipsychotic medication Geodon, and arthritis drug Enbrel.