Nuvigil Side Effects Lawsuit Attorney
The latest Drug Safety newsletter of the Irish Medicines Board released on May 15th has warned people against taking recourse to wakefulness promoting drugs, such as Nuvigil and Provigil, to treat excessive sleepiness. It has advised doctors to check heart conditions of patients using electrocardiogram and monitor blood pressure and heart beat regularly before prescribing these drugs. The IMB has also urged caution on the part of users having a history of psychosis, depression or mania.
Though the pharmaceuticals major Cephalon claims that its drug Nuvigil is an effective means to improving conditions of people having sleep apnea, narcolepsy, and shift work sleep disorder, the Side Effects Lawsuit Attorney of the drug can lead to serious health problems. Wakefulness drugs may lead to one sleep problem while solving the other. It can cause lack of sleep that leads to a number of health complications, such as insomnia, fatigue, abnormal blood pressure, and lack of appetite. We need good sleep to help us recuperate and rejuvenate after long working hours. While lack of sleep induced by the drug can impact our efficiency and create mental problems, stimulant-like armodafinil in the drug is linked to Steven’s Johnson syndrome.
FDA Warning on Nuvigil
The FDA approved the marketing of Nuvigil in 2007 only after its manufacturer Cephalon agreed to carry label warnings on it. The federal regulator made a written request to the manufacturer two months before the market introduction of the drug to have mandatory and bold label warnings about skin rash and hypersensitivity Side Effects Lawsuit Attorney. It even asked the company to submit standard safety updates highlighted during clinical trials and mention them in introductory promotional materials. Such requirements are put forward only if the FDA is more concerned about the Side Effects Lawsuit Attorney of a drug. In October 2007, the FDA updated healthcare professionals about warnings related to prescription of Provigil, a lesser variant of Nuvigil.
In December 2010, the FDA rejected Cephalon’s request to allow Nuvigil pill to treat jet lag. Though there was no official word on the reason for not allowing the drug to treat jet lag, speculations were rife that the FDA had greater concerns on Side Effects Lawsuit Attorney of the drug. Similar circumstances had forced the pharmaceuticals major to abandon plans to market Nuvigil for schizophrenia treatment last June.
European Agency Warning
The European Medicines Agency asked doctors and patients in July 2010 to shun using sleep disorder drugs to treat narcolepsy, as the risks outweigh the benefits. It even urged caution on the part of doctors while prescribing drugs, such as Provigil and its higher variant Nuvigil, for sleep apnea and chronic shift work sleep disorder. The European regulators were concerned over a number of safety issues linked to the drugs, such as skin and subcutaneous tissue reactions, psychiatric disorders, and its off-label use. The agency's Committee for Medicinal Products for Human Use identified cardiovascular and blood pressure risks caused by wakefulness-promoting drugs in patients suffering from narcolepsy.
Nuvigil Side Effects Lawsuit Attorney
Patients allergic to armodafanil or modafanil must not use Nuvigil. Those suffering from liver problems of any kind, kidney disease, heart muscle disorder, psychosis, drug or alcohol addiction, and high blood pressure can face health complications on using the drug. The drug may also prove fatal to those having recent heart attacks.
Pregnancy and Breast Feeding Problems
The FDA has put Nuvigil in the pregnancy category C. Clinical studies have shown that armodafinil may lead to developmental toxicity in pregnant women. It is also linked to intrauterine growth retardation and spontaneous abortion in two cases. The manufacturer urges caution in administering the drug to nursing women.
Steven’s Johnson Syndrome
The drug is linked to Stevens–Johnson syndrome, a kind of toxic epidermal necrolysis, in patients. This hypersensitivity complex syndrome affecting the skin and mucous membranes is mostly caused allergies and infections due to medication. It led to skin rashes caused by cell death and separation of epidermis from the dermis. Nuvigil causes severe dermatologic Side Effects Lawsuit Attorney, including rash, contact dermatitis, and excessive perspiration.
Cardiovascular Side Effects Lawsuit Attorney
Armodafinil in Nuvigil may lead to blood pressure and abnormal heartbeat. Heart patients and those having heart muscle disorder may face fatal health problems after using the drug. Tachycardia and palpitations in patients are also linked to the drug.
Gastrointestinal Side Effects Lawsuit Attorney are common in people using Nuvigil. Nausea, dry mouth, and upper abdominal pain are found in several students who take the drug to remain awake during their exams. Long-term use results in constipation, anorexia, decreased appetite, and vomiting.
Nervous System Disorder
Lack of sleep caused by Nuvigil can impact the Central Nervous System in users. While headache, dizziness, and disturbance in attention are common Side Effects Lawsuit Attorney, the drug can also cause insomnia, migraine headache, memory problems, and abnormal skin sensations caused by peripheral nerve damage. Regular Nuvigil users are prone to psychiatric disorders, such as anxiety, depression, and nervousness.