FDA informa acerca de 16 drogas con efectos adversos serios

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

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period October - December 2011 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

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)1
Brentuximab vedotin (Adcetris)	Progressive multifocal leukoencephalopathy (PML)	FDA Drug Safety Communication2 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)3
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 Communication4 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 Communication5 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)6
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.

Links on this page:

1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s027lbl.pdf
2. /Drugs/DrugSafety/ucm287668.htm
3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf
4. /Drugs/DrugSafety/ucm290510.htm
5. /Drugs/DrugSafety/ucm291758.htm
6. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf

Page Last Updated: 03/14/2012

Mi comentario:

                creo que estas alertas son muy importantes para tomar precauciones acerca del uso de los medicamentos, sobre todo los que usamos frecuentemente y dentro de ellos destaca el uso de las fluoroquinolonas, que por otro lado se asocian a tendinitis y ruptura del tendón de Aquiles y según reportes a perforaciones de la córnea, neuropatía óptica y hemorragias de retina y empiezan a salir reportes que los relacionan con  el desprendimiento de retina, una grave emergencia médica que puede llevar a la ceguera (reportes del  Martes, 3 de abril en Health Day News- holadoctor.com-) y los inhibidores de bomba de protones, que se han relacionado a diarrea por Clostridiun difficile, todos de uso común en nuestra consulta diaria.  Otro que debemos de tener en cuenta es la gabapentina, ya que también es de uso frecuente.