New FDA Warning of Serious Breathing Difficulties Caused by Popular Seizure and Nerve Pain Medicines

What is the FDA warning about Gabapentinoids?

The U.S. Food and Drug Administration (FDA) announced on December 19, 2019 a warning that:

“…serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.”

What is Gabapentin and Pregabalin?

Both are FDA-approved drug types that are used for conditions such as: seizures, nerve pain, and restless legs syndrome.

Gabapentinoids

A. Gabapentin

  1. FDA-Approved to treat a variety of ailments such as partial seizures and nerve pain from spinal cord injury, shingles, and diabetes.
  2. First approved in 1993
  3. Marketed under names: Neurontin and Gralise, as well as generics.
  4. Gabapentin enacarbil is marked under the name: Horizant.

B. Pregabalin

  1. FDA-Approved First approved in 2004
  2. Marketed under names: Lyrica and Lyrica CR, as well as generics.
  3. Schedule V controlled substance, which means it has a lower potential for abuse among other drugs scheduled by the DEA, but still may lead to some “physical or psychological dependence.”

Is there an issue when “gabapentinoids” are combined with CNS depressants?

According the FDA, the answer is yes. The FDA stated:

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse. Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone. We will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs.”

What is the FDA doing?

The FDA is now requiring that the manufacturers place new updated warnings about the risk of respiratory depression to all of the prescriptions. Further, the FDA is requiring the manufacturers to “conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.” The FDA said they are paying “special attention” to the respiratory depressant effects” during the abuse potential evaluations and clinical trials.

What adverse symptoms does the FDA advise patients to watch for?

FDA advises patients and caregivers to watch for symptoms that include:

  • Confusion or disorientation
  • Unusual dizziness or lightheadedness
  • Extreme sleepiness or lethargy
  • Slowed, shallow, or difficult breathing
  • Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
  • Bluish-colored or tinted skin, especially on the lips, fingers, and toes

What does the FDA advise patients to do?

The FDA advises both patients and caregivers to seek “immediate medical attention if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening.”

Why should I contact an attorney?

First and foremost, if you are experiencing a medical emergency, always contact 911 and a medical professional immediately.

If you are a patient that has taken gabentinoids and you have experienced hospitalization, emergency surgery, or someone has died, you might be entitled to file a lawsuit against the drug manufacturers.

What compensation could I possibly receive if I file a claim?

Every year hundreds if not thousands of people are injured as a result of prescription drugs. Under “products liability” law, an individual or their family may be entitled to monetary damages to help cover any costs associate with the damaged product, including, but not limited to: medical costs, lost wages, pain and suffering, and other types of damages.

Contact Us Now For a Free Claim Evaluation

At Schiffer Law Firm, we help individuals and their families file drug lawsuit claims against the drug manufacturers. If you have been prescribed gabentinoids and have experienced severe respiratory problems, contact Schiffer Law Firm immediately and we can help advise you on your next steps.

Contact Us Now For a Free Claim Evaluation
Call Us Today: 713-521-0059

Source: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin