Lioresal Side Effects Lawsuit
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Lioresal Side Effects Lawsuit
Lioresal Side Effect Lawsuits
Lioresal, brand name of Baclofen, is a popular muscular relaxant and antispasmodic drug. Manufactured by Basel-based Swiss pharma giant Novartis, Minnesota-based medicine technology giant Medtronic, and a number of generic manufacturers, the drug is administered in the form of tablets and intrathecal injections. Lioresal is approved as a medication for the treatment for muscle spasms, pain, rigidity, and cramping caused by injuries to the spinal cord, multiple sclerosis, and cerebral palsy. The drug is also considered helpful in fighting alcoholism and improving the quality of life of addicts. However, Lioresal has been linked to serious neurological dysfunction, reduced therapeutic response, drug abuse, and withdrawal symptoms, among other side effects.
The FDA approved Lioresal tablets in June 1992 and the intrathecal version in1996. The drug activates receptors in the brain that help in the production of gamma-aminobutyric acid, an inhibitory neurotransmitter and a key central nervous system depressant. The amino acid also helps muscles and ligaments located close to the spinal cord to prevent spasms and let the muscles relax. It ends spasticity and improves mobility. However, the adverse effects of Lioresal affect the central nervous system, psychiatric disorders, neurological response, and the thinking process of users. Patients taking the drug fail to remain awake and alert while driving, working, or doing any hazardous job. The drug can accelerate these problems in alcohol users.
Studies conducted by independent bodies have shown that Lioresal adversely impacts patients’ ability to deploy muscle tone for safety, balance, movement, and certain other essential activities. Lioresal side effects can be fatal for people with impaired kidney functions, bladder problems, liver problems, seizure-like disorders, Parkinson's disease, emotional instability, stomach ulcers, respiratory disorders, and elders with cerebrovascular problems.
Lioresal FDA Warnings
In March 2011, the FDA made safety labeling changes on Lioresal intrathecal. A safety alert issued by the federal regulator asked healthcare professionals to monitor patients taking the medication for withdrawal symptoms, intrathecal mass, and new neurological signs. According to the report of the Center for Drug Evaluation and Research, administration of Lioresal leads to decreased therapeutic response, neurological dysfunction, and pain caused by worsening spasticity.
In September 2009, the FDA
issued an alert to patients using intrathecal Lioresal through faulty SC Catheters and IsoMed Pump manufactured by Medtronic. According to the FDA, excessive release of the drug damages tissues, causes severe headache, aggravates withdrawal symptoms, and helps the underlying symptoms resurface.
In April 2002, the FDA added boxed warning on Lioresal intrathecal produced by Medtronic. It advised both doctors and patients to limit use of the drug due to severe spasticity affecting cerebral and spinal realm. The regulators also highlighted withdrawal symptoms, including the risk of possible death and life-threatening abnormalities, caused by abrupt discontinuation of Lioresal.
In March 1997, law enforcement agencies detained 13 teenagers who consumed the drug during a night party at Woburn. It followed by reports of similar drug abuse by middle-class students in the locality.
Lioresal Side Effects
The most common Lioresal side effects include back pain, constipation, allergic reactions, tightness in the chest, dizziness, headache, mood problems, unusual tiredness, and muscle weakness. The following are the important side effects of the drug.
Nervous System Problems
Lioresal has been linked to transient drowsiness, sedation, dizziness, fatigue, unsteady muscle movements, spasticity leading to bending of back arches, head, and heels, abnormality in involuntary eyeballs movements, somnolence, and decreased reflexes. At the higher side, it can lead to coma, seizures, frontal lobe syndrome, and respiratory depression. Lioresal also alters the sleep architecture and reduces oxygen saturation.
Psychiatric Disorders
Both the drug use and its withdrawal cause psychiatric side effects. Lioresal increases depression, euphoria, and anxiety frequency in users. According to post-marketing surveys, the drug induces paranoia, mania, psychosis, hallucinations, and personality disorder. The drug has also been linked to withdrawal symptoms, such as anxiety, hallucinations, insomnia, manic, or paranoid states, and loss of control over muscles.
Cardiovascular Side Effects
Lioresal intake results in abnormal heart rate and bradycardia. The FDA has received reports of hypertension and orthostatic hypotension in patients due to the drug. It can worsen conditions of elders with previous history of strokes and cardiovascular problems.
Gastrointestinal Side Effects
Lioresal gastrointestinal side effects include abdominal pain, swallowing problem, nausea, vomiting, and constipation. The rapid increase in the doses may result in diarrhea, defecation, gastrointestinal hemorrhage, and tongue disorder.
Genitourinary Problems
The drug increases urinary frequency and users are likely to suffer from involuntary urination. It also leads to painful urination, abnormal ejaculation, kidney stones, and vagina inflammation.
Endocrine Side Effects
There have been reports of women developing ovarian cysts after treated with Lioresal and other Baclofen-based drugs for one year or more.
Respiratory Problems
Apnea, dyspnea, and hyperventilation are three common respiratory side effects of Lioresal. The FDA has also received reports of acute bronchospasm in asthma patients using the drug.
Other Lioresal Side Effects
- Dermatologic side effects, such as skin rash and ulcer, sweating, and contact dermatitis, have been reported.
- Hematologic side effects include leukocytosis and red rash caused by blood vessel hemorrhage.
- Lioresal causes musculoskeletal side effects, such as return of spasticity, worsening muscle pain, and ataxia.
- The drug has also been linked to malaise, subnormal body temperature, nightmares, memory impairment, and insomnia.
Lioresal Lawsuits
Lioresal manufacturers, particularly Novartis, are facing a number of lawsuits. Plaintiffs have sought compensation on the ground that the manufacturers failed to disclose side effects of the drug, which caused them to use the drug, following which they lost their ability to earn. They have also demanded reimbursement of their medical expenses incurred as a result of Lioresal side effects.