FDA Drug and Device Approvals: June 3, 2004

June 03, 2004

The U.S. Food and Drug Administration has approved trospium chloride for the treatment of overactive bladder, a new device that delivers follitropin alpha for infertility, a new indication for fondaparinux in conjunction with warfarin for pulmonary embolism (PE) and deep vein thrombosis (DVT), and a device for the detection of heart murmurs.

Trospium Chloride (Sanctura) for Overactive Bladder

On May 28, the FDA approved trospium chloride tablets (Sanctura, made by Indevus Pharmaceuticals, Inc.), indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Trospium chloride belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists, which relax smooth muscle tissue in the bladder and reduce the contractions that cause OAB symptoms.

Trospium chloride has no known drug-to-drug interactions, allowing its use in patients for whom previously available treatments were contraindicated due to use of medications such as warfarin, alendronate, or risperidone. Adverse effects are infrequent and include dry mouth and constipation.

Hormone Delivery Device (Gonal-f RFF Pen) for Infertility

On May 27, the FDA approved a device to deliver follitropin alfa injection (Gonal-f revised formulation female [RFF] Pen, made by Serono, Inc.), which is indicated for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa injection is also indicated for the development of multiple follicles in ovulatory women participating in assisted reproductive technology programs.

The device is the first prefilled and ready-to-use multidose device to deliver follicle-stimulating hormone in the U.S. It is available in sizes that deliver 300 IU, 450 IU, or 900 IU of liquid follitropin alfa filled by mass, which can be self-administered in multiple doses by the patient.

Adverse effects may include headache, stomach pain, bloating, nausea, and injection site bruising.

Fondaparinux Sodium (Arixtra) Coadministered with Warfarin for PE and DVT

On May 28, the FDA approved fondaparinux sodium injection (Arixtra, made by Fonda BV), allowing its use when coadministered with warfarin sodium in the treatment of acute PE and acute DVT without PE.

New dosage strengths of 5.0 mL, 7.5 mL, and 10 mL are available for patients weighing less than 50 kg, between 50 kg and 100 kg, and more than 100 kg, respectively.

Computer-Aided Medical Device (Cardioscan) Detects Heart Murmurs

On June 1, the FDA approved a computer-aided medical device (Acoustic Cardioscan, made by Zargis Medical Corp.) intended for use by physicians in analyzing heart sounds for the identification of suspected murmurs.

The device acquires, processes, and analyzes heart sounds to provide graphical and textual results. Results are provided in both electronic and printable formats, giving physicians a baseline and the ability to detect and track changes over time.

The FDA based its approval on a clinical study in which the device detected heart murmurs with a sensitivity of 91.8% and a specificity of 68.0%. It also achieved 91% sensitivity and at least 92% positive predictivity in the identification of S1 and S2 heart sounds that are key to murmur identification.

Reviewed by Gary D. Vogin, MD



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