From: Mark P. Behar [mpbehar@facstaff.wisc.edu] Sent: Wednesday, November 22, 2000 10:29 AM To: fdadockets@oc.fda.gov Subject: PPA TO FDA: Regarding your recent advisories about PPA and the following note from your own web page: "...Scientists at Yale University School of Medicine recently issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project." This study reports that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain PPA. "FDA’s Nonprescription Drugs Advisory Committee recently discussed this study and other information on phenylpropanolamine. The Committee determined that there is an association between PPA and hemorrhagic stroke and recommended that PPA not be considered safe for over-the-counter use...." Our physicians and pharmacists are quite distressed that these advisories have resulted in PPA from being withdrawn from all area pharmacies for prescription use as a decongestant alternative to pseudoephedrine (PSE). Careful review by our own physician and pharmacy personal felt that the primary Yale study did NOT strongly support the withdrawal of the product, as has been done by local Walgreens and Aurora pharmacies. We are now left with only one marginally effective oral decongestant, and several topical nasal sprays. Please clarify your actions so we may understand why PPA has been targeted so severely, with only one study with as few enrolled subjects. --Mark Behar, PA-C ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Mark P. Behar, PA-C, MPAS Physician Assistant Wisconsin Av. Family Care Center Sinai Samaritan Medical Center 1834 W. Wisconsin Av. Milwaukee, WI 53233 414-933-3600, 935-2031 v-mail, 933-8298 fax, 222-4427 pg E-Mail: mpbehar@facstaff.wisc.edu Web Page: http://www.fammed.wisc.edu/wafcc Colposcopy Recognition Award (CRA) American Society for Colposcopy and Cervical Pathology (ASCCP) Other Affiliations: Clinical Instructor, Department of Family Medicine University of Wisconsin Medical School ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~