Public Summary

The following 9 Drug Safety Communications have posted since the August 29, 2019 DSB meeting.

• August 26, 2020 (update to May 16, 2017 DSC): FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
  • Safety information from recent clinical trials suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored.
  • The amputation risk with canagliflozin remains and is still described in the Warnings and Precautions section of the prescribing informati
  • Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses.

• July 23, 2020: FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
  • FDA is requiring the drug manufacturers for all opioid pain relievers and medicines to treat OUD to add new recommendations about naloxone to the prescribing information.
  • FDA recommends that health care professionals consider prescribing naloxone to patients at increased risk of opioid overdose, regardless of whether they are receiving a prescription for an opioid pain reliever or medicine to treat OUD.

• July 1, 2020 (update to June 15, 2020 update and April 24, 2020 DSC): FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
  • A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available.

• March 4, 2020: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
  • FDA decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.
  • FDA is also requiring a new patient Medication Guide to educate patients and parents/caregivers about the medicine.

• February 13, 2020 (update to January 14, 2020 DSC):  FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
  • A safety clinical trial shows an increased occurrence of cancer.
  • The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
  • Patients should stop taking lorcaserin and talk to your health care professionals about alternative weight-loss medicines and weight management programs.

• January 28, 2020: FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems
  • We are requiring a new warning and updates about this risk to be added to the prescribing information of all clozapine products.

• January 14, 2020: Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
  • At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk.

• December 19, 2019: FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
  • 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. The elderly are also at higher risk.
  • FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.
  • FDA has also required the drug 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.

• September 13, 2019: FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
  • FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines.
  • The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.

There was one presentation to the Board: Essential Medicines List (Doug Throckmorton, M.D. Deputy Center Director for Regulatory Programs, CDER)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

Additional Information

• Drug Safety Oversight Board Members (PDF - 104KB)