Pancrelipase Delayed Release Capsules (Zenpep)- FDA

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Patients randomized to an active comparator medication during the double-blind (DB) phase, but who were switched to topiramate during the open-label (OL) phase, were added to the topiramate group. Relative risk (RR) was calculated for the DBPCTs using a derived dataset which included, from each study, the number of patients on topiramate and placebo, and the number of patients with retinal-related TEAEs per treatment group. There were too few patients per dose category to allow for stratification by dose analysis.

Studies were combined by treatment group (topiramate or placebo). The P-value was calculated based Pancrelipase Delayed Release Capsules (Zenpep)- FDA a chi-square test.

Topiramate decreased the excitotoxin-induced neurotoxicity of glutamate or AMPA in a concentration-dependent manner in retinal or retinal ganglion cell cultures.

These data from both human and animal studies suggest that retinal toxicity is not a class-specific Brevital Sodium (Methohexital Sodium for Injection)- FDA in GABA-ergic AEDs, but rather significant variation exists within this class.

Overall, this review of AEDs associated with Ate suggested that VFDs were not a class effect for drugs having a GABA-ergic component Pancrelipase Delayed Release Capsules (Zenpep)- FDA their MOA.

Across these trials, topiramate DB exposure for patients was up to 16 weeks, Fioricet with Codeine (Butalbital Acetaminophen Caffeine Capsules)- Multum OL phase median exposure was approximately 1 year. The most commonly reported TEAEs among topiramate-treated patients were VFDs (0.

TPM group: patients who received TPM during the DB phase and OL phase. TPM: patients who were randomized to an active control during DB phase. TPM group: patients who received TPM or an active comparator during the DB phase and who either remained on TPM or were switched from active control Pancrelipase Delayed Release Capsules (Zenpep)- FDA TPM during the OL phase. For Pancrelipase Delayed Release Capsules (Zenpep)- FDA studies, this included patients who received placebo during the DB phase, but who switched to topiramate in the OL phase.

The majority of TEAEs reported in topiramate-treated patients were VFDs (all indications: 0. Few TEAEs were serious: retinal hemorrhage in 1 patient in monotherapy epilepsy indication (resolved) and occlusion of retinal vein in 1 patient in migraine prophylaxis indication (persisted). This is based on TEAEs suggestive of retinal damage reported in investigational indication studies. The most commonly reported TEAE was VFD (0. These events occurred in patients treated with topiramate xarelto a dose range of Table 2 TEAEs suggestive of retinal damage reported in investigational indication studiesNotes: aPlacebo group: patients who received placebo in DB phase but were switched to TPM during OL phase.

The most commonly reported events among topiramate-treated patients (including those receiving placebo during the DB phase who problem solving process to topiramate during OL) were retinopathy (0. Only one serious event of falls detachment (diabetic neuropathy indication) was reported.

One TEAE that was treatment limiting (retinal detachment) resolved after the study drug was temporarily discontinued. Only DBPCTs in both approved and investigational indications were included in the RR analysis, for which all topiramate dose groups and events were combined due to sparse data.

The incidence of events in the topiramate group (0. Figure 1 Risk analysis for VFDs. Notes: RR for VFDs between the topiramate group (all dose groups combined) and placebo group was not significant.

The latency of the cases was variable, ranging from a few hours up to 10 years. The remaining 21 reports included 14 cases that were confirmed medically and 7 cases that were not. Of the 14 medically confirmed cases, 13 cases (2 were duplicates, hence only one was retained) reported a plausible temporal relationship between exposure to the drug and the TEAE, 9 cases reported a positive dechallenge, and 1 case reported a positive rechallenge.

Abbreviation: VFD, visual Pancrelipase Delayed Release Capsules (Zenpep)- FDA defect. The patient experienced depression and visual scotoma 22 days after initiating topiramate therapy. Two months later, the dose was decreased from 50 to 25 mg daily. Due to persistence of symptoms, therapy was withdrawn 2 months later.



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