Martes 10 de Febrero

Margarita tiene 72 años y fue sometida a una apendicectomía laparoscópica. Es una diabética tipo II y además tiene una enfermedad acidopéptica la cual no requiere manejo en la actualidad. Niega algún otro antecedente de importancia. Fue operada en el hospital Menor en donde el manejo analgésico está protocolizado. Todos los pacientes en el posoperatorio reciben 5 mg de morfina y 2 gramos de dipirona. Con este manejo analgésico Margarita obtiene adecuado control del dolor, no presenta efectos secundarios. 

1. Qué opina acerca del manejo analgésico ? 

2. Con qué otro nombre se conoce a la Dipirona ? 

3. Porque razón no está aprobado para su uso por la FDA ? 

4. Según el Invima  como se debe utilizar en Colombia? 

5. Cuál es su mecanismo de acción ? Aspectos farmacológicos de importancia. 

6. Cuál es su seguridad cardiovascular, gástrica, hepática, renal y hematológica ? 

7. Sustente sus respuestas. 

FDA

On November 6, 2013 the FDA released this statement regarding updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. Please read ASRA's response below.

 

ASRA Commentary on FDA Updated Recommendations

Regarding Low Molecular Weight Heparins

On November 6, 2013, the Food and Drug Administration (FDA) released a Drug Safety Communication regarding updated recommendations to decrease the risk of neuraxial bleeding and paralysis in patients on low molecular weight heparins1. The recommendations were based upon a series of 100 confirmed spinal hematomas occurring between July 20, 1992 and January 31, 2013, which were associated with enoxaparin thromboprophylaxis and neuraxial anesthesia. The case series was submitted to the FDA by the manufacturer of enoxaparin (Lovenox®, Sanofi-Aventis).

The new timing recommendations will be added to the labels of all low molecular weight heparins (LMWH). Specifically:

• For enoxaparin, placement or removal of a neuraxial catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily).

• A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.

• In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

The first and third statements are compatible with the current American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines2. Conversely, the second recommends a four hour time interval prior to administration of a postprocedure dose of LMWH (rather than the two hour time interval recommended by ASRA).

ASRA has consistently incorporated FDA-approved labeling into practice recommendations, and as such, accepts the changes with the following commentary: ASRA notes that among the 100 confirmed spinal hematomas, only one was associated with a shortened time interval between catheter removal and subsequent LMWH dosing. Therefore, the FDA recommendations are based on limited clinical evidence and are very conservative. Importantly, clinicians are advised to consider patient and dosing risk factors that have repeatedly been associated with spinal hematoma, including female gender, increased age, an epidural technique, twice daily LMWH dosing, and concomitant medication affecting hemostasis. 1,2