Regulatory Focus™ > News Articles > Sixteen Drugs Identified by AERS as Potentially Having Serious Risks

Sixteen Drugs Identified by AERS as Potentially Having Serious Risks

Posted 18 April 2012 | By Alexander Gaffney, RAC 

Sixteen drugs were identified by the Adverse Event Reporting System (AERS) during the fourth quarter of 2011 and have been flagged by the US Food and Drug Administration (FDA) for further review, the agency said in a statement on its website.

The products, which include Fluoroquinolone-based products, Imodium, proton pump inhibitors and Vertex's hepatitis C drug Incivik, were determined to have potential safety issues in FDA's 17 April posting.

FDA noted no causal relationships have been established between the products and the risks associated with them, but said it was looking to further evaluate the products.

If the products are determined to be positively associated with the risks, the agency said it might subject them to a range of restrictions, including labeling changes, a risk evaluation and mitigation strategy (REMS) plan or additional postmarketing study requirements.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) October - December 2011 

Product Name: Active Ingredient (Trade) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of February 15, 2012)

Bortezomib
(Velcade)

Death from intrathecal administration (medication error)

The Dosage and Administration and Contraindications sections of the labeling for Velcade were updated January 2012, to include fatal events with intrathecal administration.
Bortezomib (Velcade) Labeling approved January 23, 2012 (PDF - 2.22MB)

Brentuximab vedotin
(Adcetris)

Progressive multifocal leukoencephalopathy (PML)

FDA Drug Safety Communication
The Boxed Warning and Warnings and Precautions sections of the labeling for Adcetrus were updated January 2012, to include PML.
Brentuximab vedotin (Adcetrus) Labeling approved January 13, 2012 (PDF - 217KB)

Fluoroquinolone products

Peripheral sensorimotor neuropathy

FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about peripheral sensorimotor neuropathy, is adequate.

Gabapentin HCl
(Neurontin)

Increase in blood creatine phosphokinase levels and rhabdomyolysis

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Gadolinium-based contrast agents (GBCA)
products

Acute kidney injury

FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about kidney injury, is adequate.

Iloprost inhalation solution
(Ventavis)

Hemoptysis

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Loperamide HCl-containing products
(Imodium)

Pancreatitis

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Magnesium sulfate for injection

Fetal skeletal demineralization, hypermagnesemia, and other bone abnormalities with continuous long-term use in pregnant women.

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Milnacipran HCl
(Savella)

Homicidal ideation

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Pegloticase
(Krystexxa)

Anaphylaxis and infusion reactions

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Phenytoin (Dilantin) and non-depolarizing neuromuscular blocking agents

Drug interactions resulting in decreased effectiveness of the non-depolarizing neuromuscular blocking agent

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Polyethylene Glycol (PEG) 3350 over-the-counter oral laxative
(Miralax)

Neuropsychiatric events

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

Proton pump inhibitors (PPIs) 
Over-the-counter (OTC) products

Clostridium difficile-associated diarrhea

FDA Drug Safety Communication
FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Rubidium Rb 82 generator
(CardioGen-82)

Unintended radiation exposure to strontium isotopes following myocardial imaging scans.

FDA Drug Safety Communication
CardioGen-82 was voluntarily recalled by the manufacturer in July 2011; a return to the U.S. market is planned.

The Boxed Warning, Dosage and Administration, and Warnings and Precautions sections of the labeling for CardioGen-82 were updated February 2012, to include information about unintended radiation exposure.

Rubidium Rb 82 generator (CardioGen-82) Labeling approved February 8, 2012 (PDF - 465KB)

Sorafenib tosylate
(Nexavar)

Osteonecrosis of the jaw

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Telaprevir
(Incivek)

Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS)

FDA is continuing to evaluate this issue to determine the need for any regulatory action.


Read more:

FDA - Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between October - December 2011

Medscape News - FDA Puts 16 Drugs on Watch List


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