FDA Safety Alerts

Published as part of a US Food and Drug Administration (FDA) and Institute for Safe Medication Practices (ISMP) Partnership


Benzedrex (propylhexedrine): Abuse and misuse of the nasal decongestant causes serious harm

In March 2021, the US Food and Drug Administration (FDA) issued a Drug Safety Communication about the over-the-counter (OTC) nasal decongestant Benzedrex (propylhexedrine) which can result in serious harm if abused or misused. Benzedrex is an OTC inhaler that is used to temporarily relieve nasal congestion due to colds or allergies, such as hay fever. The product works well by reducing swelling and inflammation in the nose. But if too much is used, side effects such as a rapid heart rate, agitation, high blood pressure, tremors, hallucinations, delusions, confusion, nausea, and/or vomiting may occur.

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Advice from FDA: Should you give kids medicine for coughs and colds?

Colds are a common illness that affect both adults and children. Most colds do not cause serious problems. In fact, most children get better on their own, without the need for medicine. However, since many cold symptoms (cough, nasal congestion, headache) are similar to symptoms of coronavirus disease 2019 (COVID-19) and the flu (influenza), it is important to talk with your healthcare provider to determine what the best course of action is to take.

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FDA warns about the “Benadryl Challenge

The US Food and Drug Administration (FDA) is warning that taking higher-than-recommended doses of the over-the-counter (OTC) allergy medicine, Benadryl (diphenhydramine), can lead to serious heart problems, seizures, coma, or even death. Benadryl is commonly used to relieve allergy symptoms like itchy eyes, nose, or throat; watery eyes; rash; coughing; sneezing; and runny nose. It can also be used to treat occasional insomnia or motion sickness. FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in a “Benadryl Challenge” encouraged in videos posted on TikTok. The “Benadryl Challenge” encourages social media users to take up to 12 tablets of this medicine at a time to cause hallucinations or an altered mental state. The Drug Facts directions on the package state that no more than two 25 mg tablets should be taken by adults and children older than 12 years of age every 4 to 6 hours. Drowsiness is a common side effect, but too much Benadryl (including generic diphenhydramine) can cause:

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Antibiotics and antibiotic resistance

Antibiotics are a group of medicines that specifically treat infections caused by bacteria. They do not work in treating infections caused by viruses. The common cold, most sore throats, and the flu (influenza virus) are caused by viruses and should not be treated with antibiotics. If a person takes antibiotics for a viral infection, the antibiotics:

· Will NOT cure the infection

· Will NOT keep others from catching the infection

· Will NOT help you feel better

· Will NOT get you back to work/school faster

Many bacterial infections are becoming resistant to antibiotics because an antibiotic was not prescribed or used correctly. If the bacteria is resistant to an antibiotic, it means that the antibiotic will no longer work to treat that bacterial infection. To prevent antibiotic resistance:

· Doctors should prescribe an antibiotic only for a bacterial infection

· Patients should finish all of the antibiotic when treating a bacterial infection, even if they are feeling better

· Patients should discard any leftover antibiotics if they are not able to finish them

· Patients should only take antibiotics that were prescribed for them (do not use an antibiotic prescribed for someone else or give your antibiotic to someone else to use)

The US Food and Drug Administration (FDA) has partnered with the Centers for Disease Control and Prevention (CDC) and other healthcare, government, academic, international, and industry partners as part of a joint effort to raise awareness about the appropriate use of antibiotics.

To test your knowledge about antibiotic use, take the CDC antibiotics quiz, Be an Antibiotics Whiz, by visiting: www.ismp.org/ext/558.
Advice from FDA is a feature brought to you by FDA. You can find this information and more on FDA’s Consumer Health Information website at: www.ismp.org/ext/559. This website features the latest updates on medicines and products regulated by FDA. Sign up for a free email subscription at: www.ismp.org/ext/262.

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FDA Promotes Broader Access to Naloxone for Treatment of Opioid Overdose

On July 23, 2020, the US Food and Drug Administration (FDA) issued recommendations for healthcare providers to discuss naloxone with all patients when prescribing opioid pain relievers. Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Examples of opioid pain relievers and products that contain opioids include morphine (e.g., Kadian, MS Contin), oxycodone (e.g., OxyContin, Percocet [with acetaminophen]), hydrocodone (e.g., Vicodin [with acetaminophen]), methadone, fentanyl, hydromorphone, and codeine. Certain opioids are also used to treat opioid use disorder (OUD). Examples include methadone and buprenorphine.

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