FDA Approvals: ParaGard, Sure-Screen, Collagen Bone Healing Protective Sheet

Yael Waknine

November 04, 2005

Nov. 4, 2005 — The U.S. Food and Drug Administration (FDA) has approved an expanded patient profile for a nonhormonal intrauterine device, allowing its use in women aged 16 years and older in all stages of reproductive life who are in stable relationships and therefore not at high risk of sexually transmitted disease or HIV infection; a screening device that detects drugs of abuse at significantly lower levels compared with standard tests; and a resorbable collagen product for use in orthopaedic applications involving bone repair.


Nonhormonal IUD (ParaGard) for Use in Nulliparous Women

On Sept. 13, the FDA approved an expanded patient profile for a nonhormonal intrauterine device (IUD; ParaGard Copper T 380A, made by FEI Women's Health), allowing its use in women aged 16 years and older in all stages of reproductive life.

The removal of previous restrictions allows use of the device in nulliparous women and those not in a mutually monogamous relationship (however, the presence of a stable relationship is encouraged to reduce the risk of sexually transmitted disease [STD] or HIV infection). In addition, the IUD may now be used in women with a history of STDs or pelvic inflammatory disease (PID) who do not have acute PID or engage in sexual behavior that increase their risk of PID.

The changes reflect findings that the risk of pelvic infection is more closely linked to sexual behavior than choice of contraceptive.

Approved in 1984, the IUD was originally indicated for use in women without a history of PID who have had at least one child and are in a stable, mutually monogamous relationship.


Screening Test (Sure-Screen) Detects Drugs at Significantly Lower Levels

The FDA approved in October a drugs-of-abuse point-of-collection test (Sure-Screen, made by MEDTOX Scientific, Inc.) that detects eight commonly abused drugs at significantly lower levels compared with currently approved standard tests.

Standard tests detect drugs at levels established by the Substance Abuse and Mental Health Services Administration (SAMHSA) for workplace screening. Rather than detect all drug use, these widely adopted guidelines are generally intended to deter drug abuse and minimize litigation related to employment drug screening.

The approval was based on clinical data demonstrating the test's ability to detect marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines, and MDMA/ecstasy in urine at levels that are on average 50% lower than those recommended by SAMHSA.

Compared with standard tests, the test provides significantly decreased cut-off values for detection of amphetamines and methamphetamines (300 vs 1000 ng/mL); benzoylecgonine (100 vs 300 ng/mL); codeine (100 vs 300 ng/mL), and cannabinoids (40 vs 50 ng/mL).

In addition to screening for standard drugs, the device also detects MDMA/MDA (300 ng/mL), morphine (100 ng/mL), methadone (200 ng/mL), and benzodiazepine (200 ng/mL).

Potential applications for the enhanced drug screening test include testing within institutions with a "zero tolerance" policy, such as probation, parole, drug rehabilitation, hospital emergency departments, physician office clinics, laboratories, and corporations requiring an elevated level of preemployment screening.


Resorbable Collagen Product (Collagen Bone Healing Protective Sheet) MaintainsPosition of Bony Tissue in Orthopaedic Applications

On Oct. 25, the FDA approved a resorbable collagen product (Collagen Bone Healing Protective Sheet, made by Collagen Matrix, Inc.) for use in orthopaedic applications. Derived from highly purified type 1 collagen, the white, nonfriable sheet attains a three-dimensional conformability when hydrated.

The device is indicated for use in conjunction with traditional rigid fixation to maintain the relative position of weak bony tissue (such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures) in trauma and reconstructive orthopaedic procedures involving long, flat, short, or irregular bones; the appendicular skeleton; or the thorax.

It may also be used alone to maintain the relative position of bone grafts or in reconstructive procedures involving iliac crest harvests and tumor resections where bone strength has not been compromised. It is not intended for use in the spine.

The collagen sheets are available in sizes of 20 x 20 mm to 120 x 120 mm that can be cut into required shapes and rolled if necessary. Depending on the procedure involved, thicknesses ranging from 0.5 to 2.0 mm are available; macropores ranging in diameter from 500 to 2,500 µm may be added to the product as required.

The collagen product was previously approved for orthopaedic use in the European Union.

Reviewed by Gary D. Vogin, MD

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