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Clark Love & Hutson

The Nationally Recognized Plaintiffs Litigation
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The Nationally Recognized Plaintiffs Litigation Law Firm

FDA requires box warning for medication with mental health side effects

On Behalf of | Nov 9, 2020 | Dangerous Drug Litigation |

Living with a medical condition, falling ill or being diagnosed with a disease or condition is not easy for Texas residents. Nonetheless, it can be better managed with medical care. In some cases, prescription medication is medically advised, resulting in some patients requiring medication long-term to address a medical condition they have. While these prescriptions are relied on to address their medical condition, this may not always be the case. In some cases, the side effects of the medication can be severe, causing the patient significant harm.

Issue with box warning

It was recently reported that Singulair and its generic montelukast, a popular medication used for asthma and allergies, would now come with a stronger box warning from the FDA. This change occurred after a review of the continued reports of neuropsychiatric events.

A parent asserted that her then seven-year-old daughter changed after using this medication. She provided evidence of her daughter suffering from nightmares, night terrors, panic attacks, anxiety and anger issues. A decade later, she stated that her daughter still suffers from anxiety, depression and panic attacks.

Multiple cases

This was not an isolated event. Other patients using this prescription vocalized the harms suffered. In fact, a Facebook group was created to help support those with similar stories and side effects from this prescription. Many insisted that they were not warned about the risks this medication had for mental health side effects. Thus, many pushed to have the FDA take action, to which they responded by the new requirement for a box warning.

Suffering from a defective drug could have significant impact on the health and life of a patient. While this may not mean the drug itself is defective, it could mean that the warnings associated with them are. Thus, it is important that patients understand their rights when it comes to a personal injury or medical malpractice action. These civil actions could help patients hold a negligent party liable while also assisting with the recovery of compensation for damages suffered.