According to an announcement released by the U.S. Food and Drug Administration on Jan. 10, 2020, Taro Pharmaceuticals has voluntarily recalled the drug lamotrigine, also known as Lamictal, due to possible cross-contamination. Lamictal is used for the treatment of seizure disorders and bipolar disorder, and is estimated to be taken by about 12 million people.

Taro Pharmaceuticals Recalls Lamictal Due to Contamination Concerns

The report from the FDA indicates that Taro Pharmaceuticals (Taro) issued the voluntary recall of Lamictal tablets after the medication was found to have been contaminated by another drug substance used at the same production factory. According to Taro, one lot of lamotrigine 100 mg tablets was contaminated by enalapril maleate, a drug substance used to treat high blood pressure. The affected lot is Lot # 331771 with the expiration date of June 2021. Consumers who are concerned that they may be in possession of contaminated Lamictal may check the lot number printed on their drug packaging to determine whether their medication is included in the recall. Consumers who are in possession of recalled Lamictal are recommended to stop using the medication and return it to the pharmacy where it was purchased.

Potential Dangers of Enalapril Maleate

Although Taro currently claims that the recall is preventative, and no adverse reactions have yet been reported due to contaminated Lamictal, exposure to the contaminant may be dangerous. Exposure to enalapril maleate may result in several adverse reactions for patients. Small children and pregnant women may be at additional risk of negative side effects due to exposure to enalapril maleate, as the drug substance is known to cause birth defects. The drug may also cause serious kidney problems, or cause existing kidney problems to get worse. It may also result in serious or life-threatening liver problems. Symptoms of liver damage caused by enalapril maleate may include yellowing eyes or skin, dark urine, severe stomach or abdominal pain, and persistent nausea or vomiting.

In addition to these serious side effects, exposure to Lamictal contaminated with enalapril maleate may also cause adverse reactions such as dizziness, lightheadedness, dry cough, fainting, and muscle weakness.

Additional Lamictal Side Effects

In addition to the side effects associated with contaminated Lamictal, Lamictal itself has also been linked to several dangerous adverse reactions. Lamictal exposure may result in the development of serious health conditions including Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Drug-Induced Hypersensitivity Syndrome, or Hemophagocytic Lymphohistiocytosis. Many of these conditions are life-threatening, or cause permanent injuries. One of the initial warning signs of several of these conditions is a rash.

If you have developed a rash after taking Lamictal, or have experienced other negative side effects due to contaminated Lamictal, you may be eligible to hire a qualified attorney and file a class action lawsuit against the drug manufacturer. Victims who file Lamictal lawsuits may be able to recover compensation for injuries, medical expenses, and pain and suffering due to complications from the medication.