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  6. January - March 2016
  1. Surveillance: Post Drug-Approval Activities

January - March 2016

January - March 2016

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of June 30, 2016)

Aripiprazole-containing drug products:

  • Abilify (aripiprazole) orally disintegrating tablet, tablet, oral solution, and injection for intramuscular (IM) use
  • Abilify Maintena (aripiprazole) extended-release injectable suspension for IM use
  • Aristada (aripiprazole lauroxil) extended-release injectable suspension for IM use

Impulse-control disorders

FDA is evaluating the need for regulatory action.
 

Aripiprazole Drug Safety Communication (May 3, 2016)

Belviq (lorcaserin hydrochloride) tablets

Hypersensitivity

FDA is evaluating the need for regulatory action.

Brilinta (ticagrelor) tablets

Atrioventricular block (AV block)

FDA is evaluating the need for regulatory action.

Cometriq (cabozantinib) capsules

Drug interaction between cabozantinib and warfarin

FDA decided that no action is necessary at this time based on available information.

  • Cysto-Conray II (iothalamate meglumine) injection
  • Gastrografin (diatrizoate meglumine and diatrizoate sodium) solution
  • MD-Gastroview (diatrizoate meglumine and diatrizoate sodium) solution

Medication error reports associated with wrong route of administration

FDA is evaluating the need for regulatory action.

Diflucan (fluconazole) tablets

Adverse pregnancy outcomes

FDA is evaluating the need for regulatory action.
 

Diflucan Drug Safety Communication (April 26, 2016)

Exparel
(bupivacaine liposome) injection

Local Anesthetic Systemic Toxicity (LAST)

FDA is evaluating the need for regulatory action.

First and second generation antipsychotics

Falls that may result in injury

FDA is evaluating the need for regulatory action.

Kynamro (mipomersen sodium) injection for subcutaneous use

Ineffectiveness of the REMS

The Boxed Warning, “Warnings and Precautions,” “Patient Counseling Information,” “Indications and Usage,” “Dosage and Administration,” and sections of the product labeling, as well as the patient Medication Guide, were updated to include information pertaining to appropriate patient selection and monitoring of patients for hepatotoxicity.
 

Kynamro Labeling
 

FDA is evaluating the need for further regulatory action.

Loperamide hydrochloride capsules, oral solution

Abuse, misuse,  and serious cardiac  adverse events, including Torsades de Points

FDA is evaluating the need for regulatory action.

Metformin-containing drug products

Hepatitis

FDA is evaluating the need for regulatory action.

Noxafil (posaconazole) injection, extended-release tablets, and oral suspension

Drug interaction between posaconazole and vincristine potentially causing neurotoxicity

FDA is evaluating the need for regulatory action.

Paregoric oral solution

Labeling error with the potential to cause medication errors

The container label and package insert were revised to clarify the product name, strength, and alcohol content.

Phosphodiesterase (PDE)-5 inhibitors:

  • Adcirca (tadalafil) tablets
  • Cialis (tadalafil) tablets
  • Levitra (vardenafil hydrochloride) orally-disintegrating tablets
  • Revatio (sildenafil citrate) tablets, oral suspension, and injection
  • Staxyn (vardenafil hydrochloride) orally-disintegrating tablets
  • Stendra (avanafil) tablets
  • Viagra (sildenafil citrate) tablets

Skin melanomas

FDA is evaluating the need for regulatory action.

Ranexa (ranolazine) extended-release tablets

Seizure

FDA is evaluating the need for regulatory action.

Vascepa (icosapent ethyl) capsules

Liver injury

FDA decided that no action is necessary at this time based on available information.

Velcade (bortezomib) injection for subcutaneous and IV use

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

FDA is evaluating the need for regulatory action.