FDA Safety Alerts

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


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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How you can make a difference during the coronavirus (COVID-19) pandemic

The COVID-19 pandemic has affected all of us in one way or another. Whether you or your family members are frontline healthcare workers, first responders, essential workers, or are required to stay at home, we can all take part in slowing the spread of COVID-19. Many people who are not healthcare or essential workers still want to help. So, here are some things you and your family members can do.

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Rising Concerns with CBD Products: FDA’s Role in the Research and Medical Use of Cannabis

We recently described how medical marijuana labeling problems have led to errors. In this issue, our focus is on cannabidiol (CBD) products. These products have flooded the market and are widely available in stores and through online retailers without a prescription.

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Manage your asthma: Know your triggers and treatment options

Asthma is a chronic lung condition that affects millions of Americans of all ages. It causes the airways in the lungs to become irritated and narrow, making it difficult for the person to breathe. An asthma attack can result in severe coughing, wheezing (a whistling sound when you breathe), chest tightness, and shortness of breath. There is no cure for asthma and, most of the time, the causes are unknown.

It is important to work with your healthcare provider, such as an allergist or pulmonologist (lung specialist), to develop an asthma action plan to help reduce the number and severity of asthma attacks you have. The action plan will help you determine what triggers an asthma attack for you. Some common triggers include:

  • Tobacco smoke
  • Dust mites
  • Air pollution
  • Cockroaches
  • Pet dander
  • Plant pollen
  • Mold
  • Infections
  • Exercise
  • Strong scents (such as perfumes)

You may be prescribed medicines that can be used to control your asthma or treat symptoms of an asthma attack. Not everyone has the same symptoms so different medicines may be needed. If left untreated, long-term lung damage may occur as well as life-threatening attacks that may require emergency care or hospitalization.

Most medicines used to treat asthma are inhaled medicines that are prescribed by a healthcare provider. The US Food and Drug Administration (FDA) recently approved an over-the-counter (OTC) medicine, Primatene Mist* (epinephrine inhalation aerosol), to treat symptoms of a mild, intermittent asthma attack. However, it is important to ask your healthcare provider if this medicine would be safe for you to use to treat your asthma. Also, Primatene Mist is only approved for people 12 years of age and older. It is not known if it works or is safe for a child 12 or younger.

Here’s what you can do: If you, a family member, or a friend are diagnosed with asthma, talk to your healthcare provider about your treatment options. Develop an action plan that lists the common triggers that make your asthma symptoms worse and try to avoid those triggers. With your healthcare provider, outline a plan to treat your asthma both long-term and when you have an attack. Learn what medicines you can use and when and how to use them. Do not take any OTC medicine (including Primatene Mist) without talking to your healthcare provider first.

*Primatene Mist was taken off the market in 2011 as part of the 1989 Montreal Protocol of Substances that Deplete the Ozone Layer and the Clean Air Act of 1990 because of environmental concerns (it contained a chlorofluorocarbon [CFC] propellant). The new product contains hydrofluoroalkane (HFA) propellants that are permitted under current international and US laws.

Advice from FDA is a feature brought to you by the US Food and Drug Administration (FDA). Find this article and more on FDA’s Consumer Health Information website at: www.ismp.org/ext/152. This website features updates on medicines regulated by the FDA. Sign up for free email updates at:  http://go.fda.gov/subscriptionmanagement.

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