FDA News Digest
July 29, 2002

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Norplant System No Longer Needs Backup Contraception

Wyeth Pharmaceuticals has announced that patients using its Norplant
contraceptive implant system may safely discontinue using backup
contraception such as condoms, spermicides or IUDs.  In 2000, the company
had advised patients to use backup methods due to concerns about the
system's effectiveness, but later tests showed the implants to be as
effective as seen in clinical trials and product labeling.  Wyeth also plans
to stop marketing the Norplant system.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01161.html

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Irritable Bowel Syndrome Treatment Approved for Women

Zelnorm is the first drug to receive FDA approval for short-term treatment
of women with irritable bowel syndrome whose primary symptom is
constipation.  Studies have not established the safety and effectiveness of
Zelnorm in men.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01160.html

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Cochlear Implant Recipients May Be at Risk for Meningitis

FDA has announced that at least 25 cases of bacterial meningitis have been
diagnosed in cochlear implant patients ranging in age from 21 months to 63
years.  Nine known deaths have resulted from these cases.  Cochlear implants
are positioned in the inner ear to allow transmission of sound signals to
the brain for patients with severe-to-profound deafness.
http://www.fda.gov/cdrh/safety/cochlear.html

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