April 2003

Jane S. Ricciuti, RPh, MS

April 22, 2003

Counterterrorism Agents

Reactive Skin Decontamination Lotion

(RSDL)

Manufacturer: O'Dell Engineering Ltd/E-Z-EM Canada Inc

Drug Approval Classification: Original New Drug Application (Approval Date: 03/28/03)

Indication: Reactive Skin Decontamination Lotion (RSDL) is approved for use by the US military. RSDL is a liquid decontamination lotion intended to remove or neutralize chemical warfare agents and T-2 fungal toxin from the skin.

Clinical Summary: The lotion is impregnated in a sponge pad packaged as a single unit in a heat-sealed foil pouch. When exposed to chemical warfare agents, the user wipes the exposed skin with the lotion. The lotion removes the agents or the T-2 toxin and also reacts with the chemical agents, rapidly neutralizing them so they are nontoxic.

Reactive Skin Decontamination Lotion (RSDL) FDA Release

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Cite this: April 2003 - Medscape - Apr 23, 2003.

Table 1. Moxifloxacin Efficacy in the Treatment of Penicillin-Resistant *Streptococcus pneumoniae* CAP
Pathogen	Moxifloxacin		Comparators
Pathogen	n/N	%	n/N	%
All S pneumoniae	230/244	94	138/162	85
S pneumoniae bacteremia	53/58	91	35/41	85
S pneumoniae with penicillin MIC penicillin ≥ 2 mcg/mL	21/21	100	5/5	100
S pneumoniae bacteremia with penicillin MIC penicillin ≥ 2 mcg/mL	7/7	100	2/2	100

Table 2. Adverse Events Reported in Pediatric Cooperative Group Trial
	*No. (%) of Temodar* Patients (N = 122)**
Body System/Organ Class Adverse Event (AE)	All Events	Grade 3/4
Subjects reporting an AE body as a whole	107 (88)	69 (57)
Central and Peripheral Nervous System
Central cerebral CNS cortex	22 (18)	13 (11)
Gastrointestinal System
Nausea	56 (46)	5 (4)
Vomiting	62 (51)	4 (3)
Platelet, Bleeding, and Clotting
Thrombocytopenia	71 (58)	31 (25)
Red Blood Cell Disorders
Decreased hemoglobin	62 (51)	7 (6)
White Cell and RES Disorders
Decreased WBC	71 (58)	21 (17)
Lymphopenia	73 (60)	48 (39)
Neutropenia	62 (51)	24 (20)

Table 3. Outcomes of Randomized Treatment at Week 24 (Pooled Studies T20-301 and T20-302)
Outcomes	Fuzeon + Background Regimen 90 mg Twice Daily	Background Regimen
	N = 661	N = 334
HIV-1 RNA log change from baseline (log₁₀ copies/mL)	-1.52	-0.73
CD4+ cell count change from baseline (cells/mm²)	+71	+35
HIV RNA ≥ 1 log below baseline	342 (52%)	86 (26%)
HIV RNA < 400 copies/mL	247 (37%)	54 (16%)
HIV RNA < 50 copies/mL	151 (23%)	30 (9%)
Discontinued due to adverse reactions/labs*	40 (6%)	12 (4%)
Discontinued due to injection site reactions*	20 (3%)	N/A
Discontinued due to other reactions*	36 (5%)	14 (4%)

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April 2003

Counterterrorism Agents

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