Lamictal Lawyers

The U.S. Food and Drug Administration has connected the seizure and bipolar disorder medication Lamictal to serious immune system reactions. These reactions might result in severe damage if they are not promptly addressed.

Background

The FDA has approved Lamotrigine, also marketed under the name Lamictal, as a seizure drug for the treatment of bipolar disorder and epilepsy. Lamotrigine is used to treat seizures in individuals two years of age and older, either alone or in combination with other medications.

It can also be used as a maintenance therapy for bipolar illness patients to assist prevent the onset of mood episodes like mania, hypomania, or mania. Without first consulting a prescriber, stopping Lamotrigine can result in uncontrolled seizures, new or worsening mental health issues, or both.

Lamotrigine, which goes by the brand name Lamictal and is also accessible as generics, has been approved and on the market for 24 years. Lamictal, which GlaxoSmithKline makes, saw its initial sales in the U.S. in 1994. It is a sodium channel blocker that prevents the central nervous system’s excitatory neurotransmitters from being active.

The liver processes Lamictal, which comes in both chewable and oral tablet forms. More than 900,000,000 prescriptions for the medication were written in the U.S. between 2005 and 2015. Lamictal has historically been one of GlaxoSmithKline’s best-selling medications, with sales of over $2 billion between March 2007 and March 2008.

Skilled drug product lawyers are looking into cases concerning Lamictal injuries to secure compensation for hurt patients. Contact a lawyer today if you took Lamictal and experienced an immunological reaction or other damage. An attorney can promptly review your claims and offer free case consultations to establish your legal action alternatives.

Medicine Indications and Uses for Lamictal

GlaxoSmithKline is the company that makes Lamictal, also referred to by its generic name, Lamotrigine. The medication is used for the treatment of bipolar disorder and epilepsy and is available as tablets. The medication is intended to manage bipolar disorder-related mood episodes and epilepsy-related seizure activity.

Although Lamotrigine has been available for more than 20 years, it has just lately been connected to a risky immune system reaction.

Side Effects and Injuries from Lamictal: Life-Threatening Reactions

Lamictal has had a “Black Box” warning about the possibility of severe skin rashes for several years. A prescription drug label may have a warning that is classified as a “Black Box,” which is very serious. The information must be placed at the top of a medicine label and enclosed in a large, bold black box.

Lamotrigine has been linked to cases of fatal skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Stevens-Johnson syndrome, according to the Lamictal Black Box warning. Pediatric patients experience more severe rashes than adults do.

Co-administration with valproate is one more factor that could raise the incidence of rash.

Lamictal can also result in benign rashes, although it is impossible to tell which rashes will develop into significant or life-threatening ones. At the first sign of a rash, Lamictal should be stopped unless it is obvious that the rash is not drug-related.

Extremely painful blisters, skin dying, and skin shedding are all side effects of the skin rashes mentioned in the Black Box warning. Secondary infections, severe deformity, vision impairment, and even death are possible side effects for patients.

Additionally, a warning about the possibility of deadly or life-threatening multiorgan hypersensitivity events, sometimes known as a drug reaction with eosinophilia and systemic symptoms, is already present on the Lamictal label (DRESS). Stevens-Johnson syndrome-like blisters and a painful skin rash are two things that DRESS can bring on, but it can also result in deadly organ damage and failure.

Lamictal as an Antiepileptic Drug

Lamictal has been authorized for use as both a mood stabilizer and an antiepileptic medication.

According to a 2008 research by Nasser et al. that examined unpublished data from Lamictal studies, Lamotrigine had “extremely limited, if any, efficacy in the treatment of acute bipolar depression.” Much of the same information was investigated in a 2008 research by Calabrese et al. who discovered that Lamotrigine did not substantially differ from placebo in five placebo-controlled studies for the treatment of bipolar depression.

HLH and Lamictal

A negative effect of using Lamictal has been found as an extremely dangerous and potentially fatal immune system reaction. Hemophagocytic lymphohistiocytosis, often known as HLH, is an immunological response that results in the body’s tissues and organs being damaged.

If the reaction is not identified and treated right away, it can cause serious inflammation throughout the body, necessitate hospitalization, and even result in death. HLH commonly manifests as a long-lasting fever, usually higher than 101°F, and can cause serious issues with the liver, kidneys, brain, lungs, blood cells, and other organs all over the body.

Since Lamotrigine’s clearance in 1994, the FDA has documented several verified or suspected HLH cases in both children and adults across the globe. There may be further occurrences of which the FDA is not aware, as this number only covers reports that were submitted to the FDA and discovered in the medical literature.

Based on the time and sequence of events in these cases, the FDA concluded that “there was reasonable evidence that lamotrigine was the cause of HLH.” One of the patients in these circumstances passed away after receiving pharmacological and other medical treatments while the patients were hospitalized.

New Severe Immune Reactions Announced by FDA

A connection between Lamictal and yet another form of reaction, one that “excessively activates the body’s infection-fighting immune system,” was revealed by the U.S. Food and Drug Administration (FDA) on April 25. The FDA issued a warning that hemophagocytic lymphohistiocytosis (HLH), an immune system reaction, might result in severe inflammation throughout the body and necessitate emergency hospitalization. Patients risk dying if the reaction is not promptly detected and treated.

According to the FDA’s Safety Alert regarding Lamictal and HLH, patients who experience this reaction typically present with a rash and a fever of more than 101 degrees as well as the potential for serious complications with their blood cells and organs, including the liver, kidneys, and lungs. The FDA emphasized the importance of early diagnosis and treatment, particularly given that HLH symptoms can be hazy and can resemble other Lamictal-related conditions, such as DRESS.

HLH Symptoms

HLH can produce confusing symptoms or symptoms that resemble those of other syndromes and disorders.

HLH symptoms can include:

• Fever
• An enlarged spleen
• A skin rash
• Bigger liver
• Upper right abdominal discomfort or pain
• Enlarged lymph nodes
• The skin or eyes turning yellow
• Uncommon bleeding
• Seizures
• Disruptions in balance
• Visual alterations
• Cytopenia (low red blood cell count) (low red blood cell count)
• High triglycerides
• Excessive immunological activation, known as hemophagocytosis, can occur in the lymph nodes, spleen, or bone marrow.
• Elevated CD25 blood levels

The FDA mandates that GlaxoSmithKline and the producers of generic Lamotrigine modify their medicine labels in order to alert patients and medical professionals to this immune system reaction in light of its recent discoveries.

If patients or their caregivers see any HLH symptoms while taking Lamotrigine, they should call their doctors right away. Within days to weeks of beginning treatment, HLH can develop. To diagnose HLH, a physical examination, certain laboratory blood tests, and other examinations are used.

Should I Contact a Lawyer?

If you or your child has developed major health issues due to Lamictal, consult a doctor. You might also want to get in touch with a qualified class action lawyer who can assist you in defending your legal rights and recovering damages for your injuries.