Parents FDA Warns of Serious Risks and Death When Combining Medications

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Beware of opioids for cough or benzodiazepine pain

A The US Food and Drug Administration (FDA) review has concluded that the increased combined use of opioid medications with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects. , including labored breathing, slow breathing, and deaths.

Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, we are adding warning boxesour strongest warning, to the labeling of prescription opioid pain medications, prescription opioid cough medications, and benzodiazepines.

The healthcare professionals they should limit the prescription of opioid pain medications with benzodiazepines or other CNS depressants to only patients for whom alternative treatment options are inadequate.

If these drugs are prescribed together, limit the doses and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of labored or slow breathing and/or sedation, and associated signs and symptoms.

Avoid prescribing opioid cough medications for patients taking benzodiazepines or other CNS depressants, including alcohol.

The patients Taking opioids along with benzodiazepines, other CNS depressant medications, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual vertigo or dizziness, extreme drowsiness, slow or difficult breathing or lack of response.

Non-response means that the person does not respond or react normally or cannot be awakened. Talk to your health care professional if you have questions or concerns about taking opioids or benzodiazepines (see List of Prescription Opioid Pain and Cough Medications and List of Benzodiazepines and Other CNS Depressants).

The opioids They are a class of powerful narcotic medications used to treat pain severe enough to warrant the use of an opioid when other pain medications cannot be taken or are unable to provide sufficient pain relief. They also carry serious risks including misuse and abuse, addiction, overdose, and death.

Opioids such as codeine and hydrocodone are also approved in combination with other medications to reduce coughing.

Benzodiazepines are a class of drugs that are widely used to treat conditions including anxiety, insomnia, and seizures.

We have conducted and reviewed several studies showing that there are serious risks associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see Data Summary).

Based on this data, we will require several changes to reflect these risks in the opioid and benzodiazepine label, and Medication Guides new or revised for patients. These changes include the new warning boxes and revisions to sections Warnings and Precautions, Drug Interactions, and Patient Counseling Information Of the label.

We continue to evaluate the evidence regarding the combined use of benzodiazepines or other CNS depressants with medication-assisted treatment (MAT) medications used to treat opioid addiction and dependence.

We are also evaluating whether label changes are necessary for other CNS depressants, and will provide updates to the public when more information becomes available.

We urge patients and healthcare professionals to report side effects involving opioids, benzodiazepines, or other medications to the FDA's MedWatch program, using the information in the box at the bottom of the page, where it says "Contact the FDA”.

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Nathan Rivera
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