The FDA has asked Pfizer to voluntarily withdraw valdecoxib (Bextra®) from the U.S. market and to add a black-box warning to the labeling of generic celecoxib (Canadian Celebrex), a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

The FDA cited inadequate data on the drug’s cardiovascular safety, an increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials, reports of potentially life-threatening skin reactions, and a lack of any advantages for Bextra® over other NSAIDs.

The FDA is asking the manufacturers of all nonprescription NSAIDs to revise their labels to include a consumer medication guide and to include a warning about skin reactions. The guide will accompany every prescription NSAID at the time it is dispensed. This announcement does not apply to aspirin or acetaminophen.

The FDA has approved the manufacture and marketing of gabapentin tablets 600 and 800 mg (Ranbaxy). The tablets are the generic version of Pfizer’s Neurontin tablets.

Gabapentin canadian is indicated for the management of postherpetic neuralgia in adults and as adjunctive therapy for partial seizures in patients with epilepsy.

Myoclonic movements and pain on injection are common problems during induction of anesthesia with etomidate (Amidate^®, Bedford Labs). Researchers from Turkey, investigating ways to pre-treat the pain, randomly assigned 100 patients to four groups: ketamine 0.2 mg/kg, ketamine 0.5 mg/kg, magnesium sulfate 2.48 mmol, and normal saline.

Pre-treatment with magnesium sulfate reduced the incidence and intensity of myoclonic movements; 19 patients (76%) had none. By contrast, 18 patients (72%) in the 0.5-mg ketamine group, 16 (64%) in the 0.2-mg ketamine group, and 18 (72%) in the control group had myoclonic movements.

After magnesium treatment, 64% of patients experienced mild-to-moderate pain associated with the etomidate injection. However, both doses of ketamine provided better pain relief; at the lower dose, 44% of the patients experi­enced pain, and at the higher dose, only 28% of patients had pain.

Despite the better analgesia, however, ketamine did not effectively reduce myo-clonus. At the higher dose, it caused mild-to-severe sedation in all patients and respiratory depression in 80% of patients.

The researchers say that this is the first reported clinical study showing that pre-treatment with magnesium reduces myoclonic muscle movements without any adverse effects.

Once-daily tramadol HCl extended-release tablets (Generic Ultram ER, Ortho-McNeil/Biovail) are now available by prescription in the U.S for patients with moderate to moderately severe chronic pain. This is the first extended-release form of tramadol for adults who require around-the-clock treatment of pain for an extended period of time. The tablets are available in strengths of 100, 200, and 300 mg.

Tramadol canadian, a synthetic opioid analgesic, was introduced in the U.S. in 1995. The tablets should be swallowed whole, and the dose should not exceed 300 mg/day.

Caraco Pharmaceutical Laboratories Ltd. has announced the FDA’s final approval of an ANDA for Generic Tramadol HCl with acetaminophen tablets. This is the generic equivalent of Ortho-McNeil’s brand product, Ultracet, which is indi­cated for the short-term management of acute pain over a period of five days or less.

Canadian Prednisolone sodium phosphate (Orapred ODT, BioMarin/Alliant) is now available as an orally disintegrating tablet to control acute exacerbations of asthma in children; to treat severe, persistent asthma; and to reduce inflammation in conditions such as arthritis and cancer.

The tablets do not need to be refrigerated, and the taste is masked. This is the first orally disintegrating tablet form of generic prednisolone available in the U.S.

Alliant expects to begin marketing the tablets in the fall.

Taro Pharmaceutical Industries has received approval for its ANDA of meloxicam tablets 7.5 mg and 15 mg for the relief of the signs and symptoms of osteo-arthritis and rheumatoid arthritis. This Taro product is bioequivalent to Boeh-ringer Ingelheim’s Mobic Tablets.