Public Summary

The following 7 Drug Safety Communications were posted since the March 31, 2021, DSB meeting.

• February 3, 2022: FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
  • FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine. FDA is alerting patients and health care professionals that FDA is re-evaluating this risk against the benefits of Ukoniq for its approved uses.
  • FDA is continuing to evaluate the results from the clinical trial called UNITY and has suspended enrollment of new patients in other ongoing clinical trials.
  • FDA may hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq and will communicate final conclusions and recommendations once the review has been completed or have more information to share.
• January 12, 2022: FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
  • Dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.
  • Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.  
  • FDA is requiring a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.
• November 2, 2021: FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
  • Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children.  Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.
  • FDA is continuing to monitor safety with use of alcohol-based hand sanitizers. The Drug Facts label for these hand sanitizers currently warns that the product should not be used in or near the eyes. At this time, FDA is not making any changes to the Drug Facts label but wanted to make the public aware of this growing safety issue, and will follow up if additional information becomes available.
• September 1, 2021 (update to February 4, 2021 DSC): FDA requires warnings about increased risk of serious heart-related events, cancer, blood blots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
  • Based on a completed FDA review of a large, randomized safety clinical trial, FDA has concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). 
  • FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death. Recommendations for health care professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy. In addition, to ensure the benefits of these three medicines outweigh the risks in patients who receive them, FDA is limiting all approved uses to certain patients who have not responded or cannot tolerate one or more TNF blockers. Changes will also be made to several sections of the prescribing information and to the patient Medication Guide.
  • 12/2021 Update: The issues described above have been addressed in product labeling. Health care professionals and patients can access the approval letters and latest prescribing information in Drugs@FDA: Xeljanz, Xeljanz XR, Olumiant, Rinvoq.
• July 20, 2021: FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
  • FDA has conducted a comprehensive review of all available data and are requesting that statin manufacturers make this change to the prescribing information as part of FDA’s ongoing effort to update the pregnancy and breastfeeding information for all prescription medicines.
  • FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.
• June 16, 2021: FDA warns that vapors from alcohol-based hand sanitizers can have side effects
  • FDA warns that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin. These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor air circulation. FDA has received increasing reports of these side effects since the start of the COVID-19 pandemic.
  • FDA is continuing to monitor reports of adverse events that occur with hand sanitizers.  At this time, FDA is not making any changes to the Drug Facts label for hand sanitizers but will inform the public if additional information becomes available.
• May 26, 2021: Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
  • Based on the original clinical trials, FDA believes the benefits of Ocaliva outweigh the risks for PBC patients who do not have advanced cirrhosis. FDA will continue to monitor and evaluate the clinical benefit and adverse events of Ocaliva and will communicate any new information to the public if it becomes available.
  • FDA added a new Contraindication, FDA’s strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. FDA also revised the Boxed Warning, FDA’s most prominent warning, to include this information along with related warnings about this risk.

There was one presentation to the Board: Providing Mail-Back Envelopes and Education on Safe Disposal with Opioid Analgesics Dispensed in an Outpatient Setting (Patrick Raulerson, J.D., Senior Regulatory Counsel, Office of Regulatory Policy)

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 - 182KB)