MedWatch - Topamax (topiramate/topiramate capsules) = Dear Healthcare Professional letter

From: Subject: MedWatch - Topamax (topiramate/topiramate capsules) Dear Healthcare Professional letter Date: Wed, 10 Dec 2003 23:27:32 -0300 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C3BF75.2F696120"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2727.1300 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/medwatch/SAFETY/2003/topamax.htm MedWatch - Topamax (topiramate/topiramate capsules) = Dear Healthcare Professional letter

FDA Home = Page | About Medwatch | = Contact = MedWatch | MedWatch=20 Partners

=20

MedWatch
Home=20

Safety
Info=20

Submit
Report=20

How = To
Report=20

Download
Forms=20

Join = the
E-list=20

2003 Safety Alert: = Topamax=20 (topiramate) Tablets/Sprinkle = Capsules

The following is the text = of a letter=20 from Ortho-McNeil. Contact the company for a copy of any = referenced=20 enclosures.

Ortho-McNeil Pharmaceutical, = Inc.
1000=20 Route 202, PO Box 300
Raritan, NJ 08869-0602

908-218-6000 Telephone

IMPORTANT DRUG
WARNING=20

Dear Healthcare Professional:

The prescribing information for TOPAMAX=AE=20 (topiramate/topiramate capsules) Tablets/Sprinkle Capsules has = been=20 revised to provide updated information about oligohidrosis = (decreased=20 sweating) and hyperthermia, which have been reported in = topiramate-treated=20 patients. Oligohidrosis and hyperthermia may have potentially = serious=20 sequelae, which may be preventable by prompt recognition of = symptoms and=20 appropriate treatment. This updated information is based on = clinical trial=20 and postmarketing experience in more than 2 million patients=20 worldwide.

Reports have primarily involved children. Most = cases have=20 occurred in association with exposure to elevated environmental=20 temperatures and/or vigorous activity, and children should be = observed=20 closely under these conditions. In the majority of patients, = TOPAMAX=20 therapy has been continued. Proper hydration before and during = activities=20 such as exercise or exposure to warm temperatures is recommended. =

As of February 2002, the rate for spontaneous = postmarketing=20 reports of all potential cases of oligohidrosis is approximately = 35 per=20 1,000,000 patients treated and 1.6 per 1,000,000 patients treated = for=20 serious or medically significant oligohidrosis or its sequelae. It = is=20 generally recognized that postmarketing data are subject to = substantial=20 under-reporting.

The following has been added to the TOPAMAX = prescribing=20 information:

Under WARNINGS

Oligohidrosis and Hyperthermia: = Oligohidrosis=20 (decreased sweating), infrequently resulting in hospitalization, = has been=20 reported in association with TOPAMAX use. Decreased sweating and = an=20 elevation in body temperature above normal characterized these = cases. Some=20 of the cases were reported after exposure to elevated = environmental=20 temperatures.

The majority of the reports have been in children. = Patients,=20 especially pediatric patients, treated with TOPAMAX should be = monitored=20 closely for evidence of decreased sweating and increased body = temperature,=20 especially in hot weather. Caution should be used when TOPAMAX is=20 prescribed with other drugs that predispose patients to = heat-related=20 disorders; these drugs include, but are not limited to, other = carbonic=20 anhydrase inhibitors and drugs with anticholinergic activity.

Under PRECAUTIONS

INFORMATION FOR PATIENTS

Patients, especially pediatric patients, treated = with=20 TOPAMAX should be monitored closely for evidence of decreased = sweating and=20 increased body temperature, especially in hot weather.

You can further our understanding of adverse = events by=20 reporting all cases to Ortho-McNeil at the contact numbers listed = below or=20 to the FDA MedWatch Program by phone (1-800-FDA-1088), by fax=20 (1-800-FDA-0178), by mail (using postage-paid form to MedWatch, = FDA, 5600=20 Fishers Lane, Rockville, MD 20852-9787) or via=20 www.accessdata.fda.gov/scripts/medwatch/.

A copy of the full Prescribing Information is = enclosed for=20 your reference. If you have any questions regarding TOPAMAX = tablets and=20 TOPAMAX Sprinkle Capsules, please feel free to call Ortho-McNeil = Medical=20 Affairs Division at 1-800-682-6532.

Sincerely,

Joseph Hulihan, MD
Director, CNS Research

Retu= rn=20 to 2003 Safety Summary

FDA/CDER/Office = of Drug Safety
Web page last revised by jlw July 10,=20 2003

------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/images/fda_mast_01.gif R0lGODlhdABGALMAAJmZzDMzZszM/2ZmmTMzmf////8AAMzMzAAAZgAAAAAAAAAAAAAAAAAAAAAA AAAAACwAAAAAdABGAAAE/9DISau9OOvNu/9gKI5kaZ5oqq5s675wLM90bd94ru98nyHAoHBILBqP yKRyyWw6n9CodEqtWq/YrHbL7Xq/4LB4TC6bp4SCes1uu98HQEAJcA/O1fR7z3cfCEd6BQN1anN4 UoJ9i3x3RQJqBwgBawCIiZEEmpucnZ6cAJCVRANrBAADpWqAl096B6qMfAIABLGDQ5V6AaKSrU6v t7J8tWysCIUFAQdqxWqOv0vBw7J/a76CqcbMatFM0wW1n+OgbLCmCNzKbQeUzd5K4NBRyQOiqGuE dsnH8EXyVbidK6Cu3TVR6yL5CxRJlYADECNCrDWRwERSptxYXBMglrZnC///NVxkjeCrIhnZOAsH RB0vNQJCEgHHp6TNItwUKUN4SBA+kDKDvLKVqqjRVEMVEhGl6COuIPxcBgUy9KjVAUkJEnFXQBHX AkTWCPA5FQHNPTZPDikkwGM9jM/4TT0LJ6uvIG4jcY35iKPYuSMLPJQY0dlNIAGSdTWlbp4Qnx6D AjSSleABhKu4rfxDWKIxhJIDO36cqc8pjgg1VYsccrJIk3so5oslSWcjZncXup6pcJxiS2x6kvPU NTRBVaOFXutsB9kos52jFwZ8HOhrRm3NBqdKTRn1gcm5L8reMp/yYeG9dUSK9Mj6q1gP4S0q5D18 o2Xz69/Pv7///wAGKOBegAQWaOCBCCaYRXcMNujggxBGKOGEFFZomXQYZqjhhhx26OGHIIYo4ogk lmjiiSimqOKKLLbo4oswxijjjDTWaOONOOao44489ujjj0AGKeSQRBZp5JFIJqnkkkNGAAA7 ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/images/fda_mast_02.gif R0lGODlhfwFGALMAAP//////mf+Zmf8AAMzMzMzMmZmZmWaZmWZmmWYAMzMzZgAAZv//zP//Zv// M///ACwAAAAAfwFGAAAE/3DISau9OOvNu/9gKI5kaZ5oqq5s675wLM90bd94ru987//AoHBILBqP yKRyyWw6n9CodEqtWq/YrHbL7Xq/4LCYtyibz+i0es1uu9/wuHxOr9vv+Lx+z+/7/4CBgoOEhYaH iImKi4yNjo+QkZKTlJWWl5iZmpucnZ6foKGio6SlpqeaCAaQCgWofAoGCq+0tXixBQEBjQoIubu2 db66s8HGcgjJCMWhus6Nv7puCr3KzKlxBs4B17fdcd+R4YG/BebEZQi6vwhr2gUG0eNo2uvm587z furSvM9puLYFiCYrk7p2cfLt4adPTS5XlHStOsRP17IzrQIUdBgA4YJ6Hv/b9CLYqx63Qwr+NVJ5 xle0kwsyasSkbSKcXw1vWqSj0BGziomcQUSTctw7NDvjVGSWEmahpsBW9lsjFE25Sw/l4NzDjic6 OAZC6vFlBiiiqgCjppFIryOynmW05dwD9RHLteuIOrMpCercBVvHfpVzFE5KsXnMncnFtxBavWua ij34dnBMp4TqOrqLNG9by5AqIl4T+JO20XbUDZU6UE3KyJ7PuFUKtwzmmDmpvdGtefc4pvp0L+As O7YZqI2B3/lrxmRjosVK4z4OkLly166v8UPMNDsafqvLhFPG5rqbxxjVpk9KvfLtz+y/b3uebj5x jCYHMlVcsQDiYRLdZ5v/cWZE09IuMt2jWEwK8iWTfgkZ6BpBpR320V7iRTOZU6240l836mD0UgG9 CJVMcx72FItAs/SXzCwdEhWNf2moMwtB5xEonnrHbYMaHEsVyFReGYUHGITSHXlSRTye8c6NO5U4 EJOWgXSZgMPpeOFOACoZ4FSqqMTPKlTOc5gz/0UpD4MSvdQRVAoFdNKKUwoEDJ1RqTPRdnbuAh6c ZKJTzyp9GlDPatstMGZZ7LhJnxno9cjGS4++EeRlzPzSY2sFDmZcPcyYxAao9bm1TS4wolkWe2ZR paVo+cUj6l3/9PZLWPPEk+VM69nkF5yz5YfQoIpuM4udqe6U345qyVXs/2ynwlMOQ8xCBB6bsTVl U6JMwhMXlpHuWJ5AJArTk7PP8mXls6sReyWi911bKkKircpplqv1pka4z87EJDV50dqPu1tWWgaN h1plWU+3FjfblVEFdumWCGlWT3otJiVla2Oq1BREH9s7lHQMG1dbZ/em1waVD9NmT0+1ydvVpsCs y2yTSm6rsXEhp4tyG/xCBdFVH5UrMDAzsyvSknD13ClMSe96jUqBOf2sR/9EfVGiN7cTi6HZeuZ0 z/I2l1TUSTps5GXTuPmjGhWFtVWrNwMMmqq16etwqDun3HPUuwKtpdAHxzegelmzp7d8XZvN69PR LSx5xF9ZzXXgW7Y8L//N1yQt79ieEVzq0JalDengOMNn+MrnnpQwyslwdqvei6dzYuPvrgfRyeCi 7hngmJ+OtOJY6lr444AHRvLkkFd74MP/dKsd8VOJd/vxIIfNqarrDY+Z6Yev/Zphp7pXTFFKGslO 2U+TeFftAGno/Kau+PUzG0FjqCRiR3/78KL4kwU1JLQrsShvclObStWMczmV5Od/1Evd8TgFuu0Z zn7SAd+uxCdBGXHPUnApF9EWsw72jY5uEANh7GZjtZDZz2GCS5m9ZgO8/uXOfz8Clo8O140DYqY2 VKscA9nDEipZK4LjkoXYtLc70EhNSZ1zovA4GBnufNANE2tfGm5lwi3/+ed9WLpQO7jWQiLxrnp4 kaH/oLY6G26pGFpCUfcmckUoHi+BP1SgEFPWQDQ+yC2Xg5+ebljBJt4Gg6WTYvhcg7MQpcFmWDyZ F7doERTmDIXw+9YRWcgzM94NjShb2whriEaWvGMYBgNMY4hWRx/iEY/Nu+HmDge3bVyNZmooTM8K eTixIPJ7itwgI9dgo7Rojg1ZLBWP0LQ4drzwZqP6Chk72RqoiKV3arTm0/hXyuqpBlfT0JxJjsUW ErIxj+iMpeWI2A/h1C2QnOHa55h4vMaYJYPB5Jcja/S4Tb3tee95ZgoL2D27tQx+TptZGS3Yz+Dt S0d0IyXi2omqt/BT/1kEcuXeYHjH+c0ScwtynJQ8QjsxLfFeZCOQu/D5nqc1yVD1oZGSLhrTHyXz eCFxFwBHhz2AxuSRsVGVlPIVOpbUZRyR0uY20/iTf4DEnW0wXij79UoooROWHZXlLWl5pOn5KUoG lY8eOSWvZZwUmOeMYkuVmRwa/s5wuUAIv5Q5GqvBhSUS+6CG1JcPPJHoi347q03GiTNbmnOVq2vY BJUpkI2shT4SesxSuLE8DgURJut8XOJy6q+8+Eeg9foXPnZhKKddbqdoC6aXNqIaLWbOIzWZYmSE VctgxUdbH/WStEYE1FMBa5yOK1fm/OMmHm1MPyO5oFBAJBTG4OiBO/9si3CPgyMXFRdAvvpgkOIW E+D6j0R4ascCN5kP7s4wHwKhEoCccsChIIdm/4RuPy83o4dwtqETTO9FzzFd6g4Ekvl1RR1vxin5 ssVOw/Lt7MTap/92o8HXoK19O3UPgaCsdXbqFzHAA1085aO4DZ6PDvsUt9i6VL4jM1a/2mHgcnox K2vMB3SnoYwXVYcoNQ4HVPNQ45WRh5g2/sjbqhESajDnOD8u7SKMXJYIY+amdCByOhxLCSJf5DtX xuL1cPOTLJfHGscIcy1Oc9Eji/nMaE6zIZrCyLWq+c1wjvM+nNgUM8v5znjOM7PStDY9+/nPfs6b agFN6EKfGTnUeJLroRfN6De7xBxhabSkJ03pSlv60pjOtKY3zelSAODToA61qEdN6lKb+tSoTrWq V83qVrv61bCOtaxnTeta2/rWuM61rnfN6177+tfADrawh21rAhj72MhOtrKXzexmO/vZ0I62tKdN 7Wpb+9rYzra2t83tbnv72+AOt7jHTe5ym/vc6E63utfN7na7+93wjre8503vetv73vjOt773ze9+ +/vfAA+4wAdO8IIb/OAIT7jCF87whjv84RCPuMQnTvGKW/ziGM+4xjfO8Y57/OMgD7nIR07ykpv8 5ChPucpXzvKWu/zlMI+5zLcdAQA7 ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/images/fda_mast_03.gif R0lGODlhdABGALMAAP////8AAMzM/8zMzJmZzJmZmWZmmTMzmTMzZgAAZgAAAAAAAAAAAAAAAAAA AAAAACwAAAAAdABGAAAE/zDISau9OOvNu/9gKI5kaZ5oqq5s675wLM90bd94ru98nyXAoHBILBqP yKRyyWw6n9CodEodIqrYrPYJOGy/YPAAUAibz1EDAGBAGNDweJGwHiToxTVA7tzz52sECWoAV0N+ flCJfUeLf0FjAIKEdkSJiJiXiAl6nHtrQaCco55CoqKPQJFvlEaXpJ9AsaOgm7aypbO4tKlACHpv dACVeaGetbudm7y0yriLt6mEXQmRgl7FsKbP3NrRyaTgjnGtCNaDAq6ox+yyn6+zmdrhpfRxwnYH wHfrTeO9cM5Nu7KqiKFGAP8UpITgQMEi2BJKVLXGC75B+yZqNKKPDT9JGP+HHXRlDAm0KP96EQo5 KdCSVybncdlYbVhNO8IEvSyJ6lSufj41pVQyssqYN2uQgmSiBxmzWMtgvntKM6mnAx0ZPevELt4u d16XTfxVKKu+dP6MneQVlae3r38QEDAwd4CAU2Sypk2Gt57XUFNh9ZNzt2nFBB3l2qTJ+FfdAQPa UBxwwMBdnYwnEhgwl+OYdAWSuik8F2vme4YHFIgIRJjSOoYXJyh6WghtJgawbjYs2d0kykEsuzxU EgvXneQi1fGifA1aJFdgOjloSPrpacOwISjMVO3Wen7pjQuqyR1gwEOfCB9+lGnTt9GmQvPZjFvY bmCm3QHevRtUvn8R9x64PMyAhUkYakD2XH9s/UdVF79gQ2BxbxW4zRcC7EYMg7f8Vcsevxx0nDNu gafMYEbZscoBt9W2UXvTbOhiZsMdsNqMM+oRWYs4bjQNZj0GKeSQRBZpZBixJankkkw26eSTUEYp 5ZRUVmnllVJCpuWWXHbp5ZdghinmmGSWaeaZaKap5ppstunmm3DGKeecdNZp55145qnnnnz26eef gAYq6KCEFmrooYgmquiijDbq6KOQRirppHJGAAA7 ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/dot_clear.gif R0lGODlhAQABAID/AP///wAAACH5BAEAAAAALAAAAAABAAEAAAICRAEAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/blkpixel.gif R0lGODlhAQABAIAAAAAAAP///yH5BAAAAAAALAAAAAABAAEAAAICRAEAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/images/dot_clear.gif R0lGODlhAQABAID/AP///wAAACH5BAEAAAAALAAAAAABAAEAAAICRAEAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/mw_logo_ani_160px.gif R0lGODlhoAA5ALMAAOrb4/OsrwwZYOoCDftfZk1cprO51REkiJ4EDI+YxC8/kbRcYHB7svB/hPox Ov///yH5BAQUAAAALAAAAACgADkAAAT/8MlJq7046827/2AojmRpnmiqrmzrvnAsz3RNA3iu67YL YL9PsFfBBQKNJIHgaDqby2QAR/QACA0LYTgJEB5eLgUQkBDKEjT1sjYdG0vnYE6v2wfQxrSqCVe8 F3oPcF8XAQ4PVxRqZWSLeyNkhA50CAMImAgLm5ydm5iXcw6CfBZhZ0kADl9erQEDU1tYekcOZXBX SmcAUklwelhYV7VibEhMlJeZmkc8GjgNC6CraKVms6izg77B0F6oSre+SoS+tl5642fdGZJMlZib 1SbRlqPFPQ68DaO/sb/d0J05lupQP3XYrmAhSI6dKThN5mRaAGkFmWT6Sik6BIBitB8O/xbQIrAg 0agp/K4gaiBJ5Bta6dLxongkAM0sY45FVEYRH4sGdHxaC6Gq5BiL35IpY9njFZ6hKHgJNcHrHbyK PQDMYTIPqlcwySwtw2mN35yuX4fWXNsMKlCJaNPKlft2gNG5eOcC1ZS3r9wAlvy2M0DYAAMDFAob SJBgKggAihkMgUxY8gTKhAsgPgHYMd4EBUIrOFBgguHQBQ4o8OwBtOgDCSa4Hr0ZAIPXq1NgFSwB QIHRB4KXlpAAePDcKQwYFxA70e/gAjYbeH6AOe8Y04NDV9CbenXkvROJD/KjPJDlzbND31x8+1Hz l8fLL5LjfXzxJSbfxz9fAgPjxxEHoP9qQSzGQAIMHBjaD4wd6GACm02wHAOJ/KdddBUCZ11vCCKo GYcPOnhAhAAgeJsCsRlYAIUPqDhcCAY9IeOMMpZn4YXc2QagAMiBpsCPo/HoHJBA/saifxdSOB16 Lab2HQU+/gibBEsSCRx7JwYZW3EKCDCccl2+GMI4ZJZZplHqaafaA6CpeVwQNwogp5BpunnAkQkk yeaOscXZXIZ6simAm3Lm5mN1cyJm4YaLiilEIjtEykN9AhLKXXtq8ggndAU0iJh6PMqpHXIGJOkb n6d+N0SbFw7n5IXVlbYkokEakOoBcGopgio09voEHjYCp4CTKDIQq3G53SoZZJVqqtz/hbWpeVhq AtwIoYZ/2vadsD/Ymud6tqbKI2IArOabdocZVusI6SDxxrvuukuLGs9V+61qtTqp6ZDaPedfkMPd i6Fz6N5YbnAJBnkAlNRmN2iEz+7LJrXgUQkgkIiyVoR8VHRcnnltYFptqZlKRl1uaQ7qJZLVsfhs dRG+KqWmzw2ra2//CalvhO0JyXK1FmBqZ3AixOjr0bmudzC0D2jIXYsazknhudU116bEbNoZXbk7 Pk0ltRT2fGSj3QEcdNSDukeUL0jE1PbbvVDUm4a4cu3e0gTuGeAY1H1KtmyE4vqAd1VfdmOxZktQ b3NUB9cYm30CfC2npbDq84RQb/fD/+EQQthkvydmnNiOpTVeneBfu4ls2YUrrqYCt025889/EiGy q9AtnAiymyNbANAv4wvdhpctN7B3xD+wqMppV1eehkOQPGpwOOgbxOxVKMd8c13K2Zyxc5o7PKLW MSDqnKJGWPz5T/uGvgBD5Ox9ZdtnPScX5p8/aIvkP58oHwngkZQ29SMCdmk1BhAgkTCUGiutyCcN 7NKffvcj4nGtS0cCgADLp5o1VaA46KOQsQ7YLeFp7Doo3EAbUsjCFqbwhC6MYQjOIMMaroAfZLGh DkdgkBzu8IcdUMVWgEhEDghRFF6ZFBl2U8RIKEV9fDgGMhxgCR820YmgiEsNdAIPpolcEQWxmIMV ZeCOsMQDhl80YjK8GIMlIkMimGBjGlmwAFFo8QTQgIgZ5TbHGABmK3IkgRGUYMYz9vEG0hCFFB6z xEkUkhmHJIJNLCGKVcyLLfJawhThoQk+RpIPZJAGKESBh1/tBI7L6Mkn09KSZbjylZ3UAxpXSQQj HEEk0VjLLGnJy176kgURAAAh+QQEFAAAACwAAAAAAQABAAAEAvBFACH5BAQUAAAALDwACwA/ACUA AAT/ELQVaqChvb2BJI4zDAhCAVyqrmzrskAWjmWDvniud1YAko7AbUcsdkANocSx0BifRYuHB61a r9isdsvtPgGGsIExBIfJHHO4YPC2EoW44pDgwAvz9gPAkB8UQ24pBgpzBwJ1e3gHh3oGi4eJRSiU HXuXMIaRG4+MjRsJhgIKKZWBpg8MDHcoCa6vrnochYwCDHsMmgJtfKKSAAmrfXrAwsG0oxt4CnLM CrccDJ62D4+6dZ2HpHbLc4nWhYUC48nWf56GktK1t6Gem7m1v/HsoALvBwWuDG2EtQrj0N0wMI0M JHkAFo0aAuedgALK8NnyoAcOQED+at0AoIlfgUP0/xJkRJRG2ihDgKoBm5ZvzoZ1D0FNI/aRkSpD HG3Gu5ei4a6P92T5G3UoZqo51KqJGrKuEJ6Fi5xt6pArWc1ddpACHHcroTxQT1O+RPlnF0dN2gYB bYcU2tFDEEtB6rczLiiyf1AcnIoL5TG4HBTGElmtZr4+4gQEylgWoleWQ7KhQ9dBMDNqjGkVldRh DjI9Ufm+DRhQ456l5OowIE0u6Iqc5LYlvEeO6VZEZ2iTTFBUsbg2H8M5RcNCmjhJBU6S7CzOLQDl qv8UCiSouvXr2KsEyL7FgRPuV0J8Bw9FxAAC5KuYH+AgPYxTMTasl+V+Q4Yk25fYeOCgxIDt9T2Q ASYIBBAghBIcCEHACONlF0MDIIgQQgUtAGDeftfF4MMMNCAgBAsRAAAh+QQEFAAAACwnAAUAZQAy AAAE//DJKQG9OOudgQ9BIxKEU54mIQYe515AIBGyVLed9bpfQJaO4GBILBKDKtaOE3A8AATKTRaT Kpcaz0joQAwQhMVCNC6LEV7vwNGoYZuyBgE6ogFWInlbZaf5dDwUMXJhYiwegBtaC2hrNFhycW0h dSoiDiBJeZEjiTAxhxOgV1gaDQtDbJ6mDTFBm3mWcyRtsLCrH3kgFqulLgFqDr0XJQ+tIWMgKyGU IXcLIJnRnz4/Kzi+vgFEwxMOC9lYWiRB323d4b8Oay6t6TzV5Uhu7+HbAyX09TtQQmsIC1Ts29dg 3QB9A5lEixYDXcJ2BhEgfEix4gYCRMBZ3MgRQ4MvGv87iuQIbIAGAwYYGKCAEmWCBA7FoQQwU1RL mDYN0FQ5EFivAgoOFJiQskABBgoUxFySMgEDoyslGHD6VMfOpwoKLH1BisKBr0MlJEj69YDShwaM qo0K4Klaq1iDJhj54KsABRWAljWbiNeTv3/9dsAKVSqDBUAVRE2QWKigwI/9ChaEyOtXvA/GBi17 9sFUpy+davUc+uVUT26Tzs2cOOnKtq1XP/n8lG3p0EijPqGKdO5Uu3jbbuasg3FSoMifMHC7/GgB 2Q/cAvUd17VnpEkxi5WuWKrRrMeDLk6tQAAD1pzRc+YrNmh5AQcEDE0bvr7stInP08+uYK5x8aJU d8D/eZllZ1ZQd1ngFILwCbASUsAVeBlxEmAnVAJTrZRSdq0dp0MA3x0AE2HZ6VQdIPu5FxYDB5J1 13yJwVdAfCZmdZlT8el1GS86MkBTVBtmRVOHVvGHIXb/YdiYbLC1mJQFOo1Vlk4exDgaAEph2R9n CKYFHC8QmoWVgmQRaICBbGHX33/CrdkaSxBuyJ535XVmXIIXnHmAnmWZB4COmHk5nHkVJiXAavg9 OYGaagn1J3JY7SmKlENZqJtmju1mKIEUSKllnyvxd9aZ7pV13p9kIYrdaGJ16NqjorJ6XVLnGSfi BHcSKBxYGDB2AJZ9BtfYqGSFFWCJpOnFqWffcVhh/4e3VvDfc7ZyauFqqLqHEwNzQfhnn74BasFT N2bIbHbcxiUrs2oFdaqa2cHJn6t5zXjoomYdiNVcej0wY3wHSEWWWRLoKNSM+s3boT6wGWVWVNX1 16mrovJolgAoXsbfr98G/B6hmcUnAHwelGfXyPcmoLGBC+gmClALHLdoxbi2dtPAK0n5VSIJNNhg wAaIHN2BOrBoKF4G3CXqr/5mpdZROGUw1r4VIEV1vUBxiqVR9yKVXJ6bwXee0QLQZfY72Jyt9tqB sO12No+8LfcOBTUw990bNIEJ3nwLYlAUffMNgD9O4N0CL6CwbdAALr8dwg9BeOHO2YN7sbfcd8hB +H3ka8uAygB2s00JEEOMsRVHgw/BuUg9kJBRV3d/fjnqT2RSQjKnn10SPqujXVkFlIiQO9sAMJLK CqX0sBA2oKQdeAYBGL9GCpPswsJCm/xAwi7PpxMDI42sI48J5I8fREDCD989DMig4f77XyDQxTfo O79+Qj3Ucs4h6lsUAQAh+QQEFAAAACwgAAQAdgAzAAAE//DJSau9OOv9gPRcKI4XSJ4boAJB6wZq tcaoGBCmHEjELvk0S7D2cTUISGRjCcupjK0c0XIkYAKOjnUC3LEo0dozsEyaCcyV7FlOwqYWHLrh cuyOgDkSxiQf6WV8LTgcLGRIDokLiwt0aoUqDQuJaFJEdHtLR3dMepqBfn6aZGSWE4ZViQ6LTHBc DZRvcGg9h0sslJ9/o3MAuoC3JX6Iq42yrjKTDoRTDo6weVkNLJJ0oaRM05IvCy4WLW3FjsgbWImm RACr5BiRVUis6OwV5lnsvvJw1ATL8N3zJNTR8gHwHj9VjKYVDHjDwQCCC11FAWCAxZeII+o5MICx o0cRsP8cIGjwsaTJbwPWnVxpMsAkfQZiGmDAcYLMmAnyBVwR04SKihVP8QwqEYFODQkKKC2goIBN BlCZFjgqwkCCqwlo2rzKYOrWrFCpcjh2AgDTA2gPOJWQVIFbt2I5zITatSaArEtB3IW6oEBNlhYM nE2r4AODt269nurAWG/jDHgXaH0wc6lfCXO7MpDBmLOHz5ZmUPg8uvODrgoIF37QFrECEFaxcmXg ITZWmRWS0q2JdynHvV0X/KUok/YHnLKTDo/dNQHl2YZ1fz584G31DoddK+69tKmEqJrpOp+At26H 8ko5Wu1aYPNWupcpw4+aHjPet86TFjjgXr9azPupVtj/TK7BxRZTrm0mGIKJ+WaTUgwIxxp7DlZW 3wfcFTDegt0lxhZq1nGUgFsHjDeiAgL0R6J1U52oHQgu+mXVb+w11WB7erWnVH4Q5rUXhBRYZVl7 3w1po4KoVXeWCiDCSKJzAGTXVHZ+nagUYtOdlRNFmLFHm4VM6RWcjOyBReZSBN0FoZegLehWRUwi 6JVZFTFIU2Vo0UgiAzEuKeWcqDGF2oGCApiXYUslUBlt7K23VJDBgWmCm2tNmJgUgiF2JYkenIiW oq6VaJachiLGH6EKbEihCbq1B16U4aE2XHmnOWioUhhqGRiDoa4mpQAVWYciRwx6lalrJjba5aHL Dskk/4WFPrUjZVf+pZ8C7tXqYW4IElbddWalJsBr4X7rVLiXyhftKRT+dt94t47ZKbQantIbTfdO EFWqH/Aa1FXa8ifknqx1Wxi6KEJZbKdXyhgTdmWud5hx0lIIpX5LUazukJYhytRfUk55mHPZAfud uPmlhqJ7BgP4lleBtpeUcxbSNSZEEFvGm2UKQNSbjU0dOqqBmGkH19ACgFAyR6mhZfIDAQpgosrg FlttwX1JBt5fFLDXV7YYKzVpwwFU5KICIjKYw9lvUdb0ax0UIMABJqv1ltJ3sxV0UxQF3V5fXoEl ngFkUaBbV0CEV2+/OmYLALZM8fhoBcemttmI+xlrN8DcgHU+wiOehy46QHGNbnoGdJyueg2krO66 CHmk/vrs7VRBEu24U/DO7aOTNkbuD7xT+kKiJJGIQrT7ssAeoftyhCoDjDQ8YB5g0QNL+xwkEgKF A/8AP9d/hAos/CAgUvfeS/C87AuhQgwCi+Cc/jfgs68PNWWoggD8yM+fAvloCMPnxhCORJivEUPw XyHKYA30zWB8xuPHJFjBNQWWhRoTGQ0Ez7CKYvRgehbMgGiEAo4qTHAO6AthRFYwkRHiLgIAIfkE BBQAAAAsCAAEAI4AMwAABP/wyUmrvTjrzTv4YPg9QGeeWHmpJou+2hfMTd0QeE7U8wj/gJ2F4JIE CI9jcQIISAhOo8Rnof6MgRrOwe16v7hGwHrlKCvHi/hxQ14CDpJbSnI2Kb0rbcsdIAZ+CAgECzs2 PDN5FEtleERQNQAOSEeVAQNjj4hwTjdBWlAAPDY7RzcNQTMOjBVNbQ6AgQgLC01kKa22jRdhN1mG bKSeokeQWp2Hp70NDjOlo4aeGa58gbRruyRNWWPZE6s1DlpinzvmTeZ7kXDiyb2Pz9HjRG+/BLB+ C+TercWo3kGSrFqQpdYDB/qcLSAhbgyzIHFQFRSThaKYUaIIJtLYoJ+WPrP/CLLiJ2fSSJInJC1c RNIVM5AiUW44wkVmI1Eny4jCMaDLrG42Z3LxFbToCziA/iglaLQDzWZNo85M1EORVAzsYEW5yrVr mZfivIode+ISQrJo075BECctAANwDTAwQCGugQQJcqaE+9YAi753//KVS3dXAAR6jSYowLiAggIT 5DZWoCBxB7kMGDAu/OBuAs0q3mZ2XMDyTNMyATA+wPoAZAmLKSs4UJmfgcaOCwPQzFiBbs2yOavd dZsybdoS5M6eTdtFieckpkRnpboA8MKSexeOTfm1dOgsod8KEb48k/PS00+noJk1cwWwHbtHnhyv /c+lH9y/L/yBZuAJxDcZ/10AcOcbE/flR4Jn+xXAWYF4aRagZ9Ylx8BiDAj0xYYcdvEcA8YdB99u y4mowmePOTYbZLuRhlsBAU7Am2MTZvYYZTXK5l1nMx7II27AHShakAcEuFgBB2TYmXzwBZPMk1A2 sFJxx9EGH5WyUXaicQKwJgBkt6lopWwx6pdljaRRRhd3BzwYJI6wZSmbayVI9p4AJYB4gAAxJkCZ ABk+J8Kg5IEQmZjvFYhklXRKAGJ3cCVAV3ElZqlgmJRlaKOKCuQVpII86qiAkiByKluGyikgwI0C +AXcAVvumVeHtHbR04fGWdcdiq7JietsDPSVnIqlUarlFGl6iqOKcInppv+L3QnqZ3AgvOogCZWp dipc7bXpCjfgUkTVRYkg++eFOi66m4kkvAlcfMDGadxvKuKloradGljXo6nWNqxsExhYxG1j9van eNokPOh0LEzLmqTLGResmPkZe6q8Sf47GwuPpohkab1ZJ9+DsUH2aJsBy/eaovFWsJiIJSJX68yr OLpcq9pa2eoDFNdJLJmO9hajZI3CK6dfBuu472xGAg1vxu0upyQFsXnpnqrw2cDNKORedBFTJIiJ JwBZfhl2xD531wpvQk47al1yPpZn3GWy/Ji9K8pY7xQnd1oCXv4teiGlgHpTNX1M8nm2bH8Ta1e7 jV3Itr8aSwy5pUuLqnT/1EzLWLCNAcqHpwSil9mIn14qiajGjR6ZIogTioxbcK1wSlthHXeecpZj HosvrJHBbFwJKu7MM3P9/WDAbF0qzrOXfVa6eHe56efYAqOtmDzZmJ/NrtFtulpl0166kECXra1q pgBdPse88afTdq/Njm0Z8luPzchYnthnltkCfsHA5MrkoiIxwWBTW97eSvUYCywPa28rldk6kyXU DOeCHrAgBjfIQbJosIMghAE2QkhCmVSihCjkRzG2ksIWwgAiYXGhDFNyj6EMp1Db+KAMa0iPtNij hn/oyAxfoBIcsNArv+hDIP4xxBeKwiReoQZIBCHEJjbiFEcMyjZuMEUEZQDFiobZR1H20EWwgZEf 20CJDEABC0GwxSBntEkRbhGDLb4CH24cYRybIgOqVMUW42KjEt1IiyzukY8/5MMkamirNsqikDo8 ZDa2QQgvyCIQDpgFQtYQSUmm5i0BMMAoEkFHDkYAACH5BAQUAAAALAgABACOADMAAAT/8MlJq704 6807+GAYdmSJAaeJmiz3BUEjE4Rj3zYtB1/bAoSGhbCiBAiPY7ECCEgITkm0d6H6JrAG7Tboer/g Qa7Bu3aUleOF/NAiLwHHA2iUNOdRadnXdDu8CAMIgwgLhoeIhoOCXQ5sZhlKUDIADkhHmAEDPERB ZDAOTlpAM1AAOzJaZEFBQKBLJzE1f4KEhTAjGh8NC4uWeZAUOlqyMm2prLtHkzOiqTNuqaFHZM9Q yRl9NYCDhsBmvI0NsJAOpw2OqpyqydRQxeNx6daenUHw7KNwWjZdhAt7glFoskCMOYFzLpkDyAuF gwWfCCyY44gHOiBy4vH6tCNGjGqn/wDCCCBSyEBZ/WoBJIdwQpNG31peqTRxoMwmW7iNk8lB3hue Zk6xFHhqG7eAQHWhGpq06YY4/moNMunURRamVbMaGckVqdYqPEB8HUu2ZQ+vZdOq9dAk5tq3cE9S fQvAgF0DDAxQuGsgQQKsKvj+dXmXQZG6dwvoDYYGboICkBUcKDABL+QCBxQALvE48oEEExIwYIB5 BQDSBSRrRoiWLIDUB2JPDi1Z9mqEBhToPiBg8enUkhcbgM0bdNyWw2XzVmCH+PIlKKLPsTN9KIDa CgQYH647uITHsQUwd1mdSXkrLsWSP0ydfPvp76VPYKDa9vfatlf0ZSCaP2QUfvEnYP8Ci02AWW0M zEFadwfodVpt2rkkmmiK2RGgXxgqUCAAAZIGWl+PJfjAfpAlgcOJKKYYHX3Kiacgfs99B9xuLr7W XXepiSgBi5J9SF93EXK3HAWd7bZdZLqlhpmDlkUWYQK6CUDZiFFO+cyVWGJZU3LKZfYAeF3exiJv ApTJHJddxqYjA5npluBju8UGGpThGfeicsYlIIBt4Y0nWpR79vYAixEOKpmU1Ymg6AjqfQljbMzR GeYKP05GIIEjYrZcmflJYIBthv0I5F+wuRiapuFNWYB4mZE5G15RKpCaAB8QR+mhf6Wo64lirIid pgqIxptzqz2oJmL3QVoXfoLOUR//gcBJalepdj4oXpwoGMChcnbNQVwBIGj4mmx5wcqbXtV4pC5H Wag7Ran8QUojl7r52t2COx46ZQKyNTtubAVIauMBo2G2514Go1lgbmSemt1tlcHIYJk9SFdxdBgn SludDPdrGHHj5cYgbyISKqLI5xqIXZUDe1boiy5q2qyjw9phsgWSphnbA7v2fMOt4WkLo6AMhgxc mwTfWSic4hXBpmqHagsbjeN5qumbh66pb3O1TUkkhJz2eUw1ZH9kNioA2UHjAR/s9rCzbmcLnNee khabXpaR/PWkDzhXnEtjBkuo19Q2Z9tgfhk6LIEQ0m0GmKbGGeSNq8EpK18KHhhw/6m07jU0ZQOH x3ZlqEJqn7e4GqicAnaDJvNibP4tkKSI9o0f15KBO+iMkSUo5Mhl2ql2v82W/rLiZSbfb3QQFvHp 6rHVGt4KrwuUW/KFZhd8sg/XmuS1gvLbJacFunTokN5iP3q+nBKIV6BPktn5fHuGd/CnyTOffPlX 6MngrfXKV2Qok5sFFMAQkUGBkpQkq8FcYFVRshMEs1MtIOkIAOADzdO8VIHrJS9BT2vaiJC2ma+U 8DgqOCEKV8jCFrrwhWppDQxneBMV0vCGJGgUDncYFI/w8Id8iIElUMiottgQiBPgRyiOI4tZOCAQ c0FiDpXolrGgRCdHlKIUAFCQTX+kRRu0+EcWtVgBWhBBK22ZhT+mMkYyWqCLS0zKLpS4xrS5USYB CMQAWkGUPvBjjd1o4x110QtxPCKHbfFDGP9RxUG2hCR6NMg9ujKSatDAidwohB0daUJILqIRBuFC SgDJSEFyEhJ96IUtVslKQ5DBlKcEygtgABFecAWWWokAACH5BAQUAAAALAUACQCIACoAAAT/8Mn5 CGmNhIwfxhcBAE1gbWDgfWB2YU5glqwWAlQObIQz/IjgYqHKGY/GxgIxcDRwyOjEQWo4OQFAiCOa aXiYneNae4kstBc3A83xxkBhVkpHin/U+lH7CFCJSjgOCyUmCw8ATllWWg4eO0qFGDI0NCREMgGY DTpvPgNybXqjOQ0/A6KkqlKJhxSpq50Wn6AIT7G4EgF4ub2vt752GbS1c8GxAD89RcfNwX5AtUGc zrhWP8zV2qqZ3TKw23SmQNnh5ufoHqeu6e3uzaYI7O/09dxM9gAG+wYMBhT8DCRIAA6XPn4M2hzs pzBggX/PEBQ0l6CARQUHCkzoZ7HAAQUT/1dVvHggwYSRGCECYEASZDNj7gAUwHigpkYJCWjWdNnM gE4BJhHNrCkAooGhB4Dac3a0JlEFEmT+5BkVkVUoOLLa+Rm0KVGIOZ++ujpWq1YdI0SBUziBbVVR DHTuxCn3IxSBDBIwyGsRx8C8gBNAnPCTAaK4Tosepqk0ql69Dx0HBnxgMAC9LBWYxEvBz5jPoEOL zrNSrgCopZ0m5VlRgWuMp4W+fj3T8AQGiQ0f5frAa+yTM12XlLB7Nk2wmWGbzAmVAovn0KG78qoa akXVO6EgTiqgO1Tq2A/YfpAgN3nTJrc3XmyevADs3v0O7d79H+KyafPrT4toxMm6sYWl2v9p2hFV wF//+KZAd07xZEBuUg1I0HxUXZfYTR4NmJRGu3EHmwERtjXaiKE1kdV2CmSoGW4CIGWXbDUlpA9d q+nzk0qq+eORANsJxlhQh61Gk0sglvcViBGe9g8AIMlUk3MbRCmlJJRIWUSSeTX4YYYEwmgTRhIg 1iJOiamUoXjbMRmjmAdQcF1RO1a2EWys7UgVcTS1RZZ/fGZlVhsC8vjggAkhReSZ7435AG5J2ebT VxOcKRyBQ6WoXFtxxcblYGH9tihR4/33ZB8klvqZdoyBaNo/jDX3KHfdGeZkUkG9WWF4RTFpWnPE 7WhYp+OJeVOSN7mZJyIfoKDsJMzSQET/VIwdMIJwqyGik0sC8hoVUgkK6yZ80j7gIq2YDqkXbMXO F9SsNRFEXnqwVWPhb4X11ioOKAomWG9nFpAZd6K8aqBQGrYB3kcNbnupBGd+xNJwXMrLGIZEtWlt g/heWwCP9mpJ1HrQJqaYuLzdBlui7xGVFWMGY0fTCBH3tCB3QS3YXVAsxgfAx7CmxyB9DA7Wls3V CgW0AG1kevM+DKC8HKxw0cddmw/S50wCpwlXoGtbLwiSAVnPpphHxvlbENkLArmxa+vpuuB4AGSt FG4YaUsX0IbR7elSfOcTUt+ABy44K4MXbo8GhifejhXUKO64Np41/vjkviSiDOWY52I5bS+C59ff N5mrsvkAQvPNQw9jMCF56HUkEsQA5dTzxinT/M26EVkQ8MPq7UDSQxzy2H67HZ8Ag84OJsAhjfHD 57IAHrE3MwIIysvRvDMBMDHABcLTMQIKv0sTfDjdd74EHpOIjrwL1QchT/TORAAAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/mw-mast-tag2.gif R0lGODlhCQEyAMQAAP///w8iisPI4kpZp4eQxB0vkfDx+NLV6eHj8DtLoGh0tiw9mFlmrneCvZae zKWs07S62gAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACH5BAAA AAAALAAAAAAJATIAAAX/ICCOZGmeaKqubOu+cCzPdG3feK7vfO//wKBwSCwaj8ikcslsOp/QqHQa CwQK1NijYF02rIPsEGFNJBXWtFUAlg3UAQEgvWBATI+0yrG4MuQpB2lhO4JdKXlWDEoGDQZLbAGE R29wAxBWCjJ9ageRapoklQGPJwRwdymnijyRZiloVgRJBgkBi0oOsklwiquzVXAAmL2AAGRpxiTI nSqVk6YDAwcvq7gotgENRQ/SD8NlpUhfAd9KnIAMazGGASSrCgJcAaEA5OsmulcCCPXYVgic4WtB DhiKNOKErHIgosGAhJQGIkEootIBBMoACKB2ghg0dQFmkZvESeIIkAZH/xgIWEKPSn4k5sGoZG7E AY7IXokwANMEglQ2bbIEYICjKJM2BUAUgcCoiYwllKoMyGkpkXYj0pDbNmzeQxPWjga441EEMU4p R1RakDBPgUQB2h1apU0EHENhDFjBUmKeAFeVIHy6QjTWLRGx1BFY1cCWglpWqB3g8oATgFFxKsk5 wOmt3Uy7SiDoo0CzNS4FHrlNxDdJ2WO9wgwOwLCEYSuP0lCLRChWrLQN0yTAOW/Q4AUA6EaWa0aP Pq4k9MBNQ0BfG8zlLqtxcNtKSTkl985RAyAbAgTFr/CMbQJ7AAQg1fBLL2kJPBGz61fKBq2iMGYi JJJXGb+cgF4aqSXXS/88zzzATDYEINAgAJaZF5V4yskiQDYKCNbLInRE6J58cHkFQCwLzKJHd3EQ o0Z/cumRjXz3pOHPEb+JoE8CHOJlABf9jTeIRt4FV1ciBAiIwmRalZcJWidacYc+BEQyy0L+jZUJ Hm2AdM8dmkUZQB1g6IWbCPMYdo8AIEmzJTGaGJKAmdoks8oAEJawSgEjCWmYk/RAqURgRj7wS4aH kUAnCfoQwsk32XjSBgqQ1ZdGP1JqF4em22kKCDnZQMUYoAiECoBMFFphKBi87SSeHnr4VWCBkfxR JDogQQBSTVkSQAwDORmCxaUgQVWEblmyuUZ81F045ju7wFVUL/Uhwqr/eJxQgyp9m1qooHAnoCTk qYeIJ6QBvz2HHxg+FolQLHLEcsehivwIkEVhkhDqL7XyFgkW2TLiUqqkRFrJSn/lM2mWDjBJjz3U tjZCUxrN08An9xBV5HhmeMLRwC5mZ0KoOZmJXKtCWgcBlgAkcrEiraZhHTUWibnqmKsgp0dVLVnR wDwry+IyxgMjEQlynw3bRa6ogeUzCZzMmKBXeBYd4Jjy5XfypFwsoM8ieI3wicTRAdRvGy5/pgYW +dIbkrrUqp0sXRYjozNhfRVDzs1V9qITEo2uK0lOLcMBXCW1qY0gNcS88onToGhsSeF1AcDsprWW HZKBevySdoGAykww/0uayYslfWaYjGYXMabm78Jq9eKpZnQOqQTocKI8yjVQDyTXAo6IAFJt7QzV UHHQqUPm5iyPJvq3KV16gisQl4NlsSI4XPnA5mkW5hcFxCJbG2byZdgC1FAJpwnEkIOcTBa+sTxw YngMSU9iW1UCT/hPvyUP/DPeDPrXAk8YawUXeYFUxMBAItSsgRCMoAR7gIwgTfCCGMwgLFSlwQ56 sIN2+6AIR0jCEppwB/A6oQpXuAP3oeCBSpAdEawjjcQZ4QC8GiCCBkAA/Z2wJAc5hBJiZEEf1Oh/ 3EAKDKxjOxaahTwmUN0SQpYoHEhoANARSwKKI0AelIYQ2bChDHJWEv+nrPA2XUTZ7ZCoAzX2Lg50 OmAOXPKjHLrBCg6w16acWLs9Zg8AVGLBTQxkjAQqioAjyJELNnICnpQikCagyDyGghGrHAAijIzi HcKWAoyQ4JIqQAe5/AgAQ2okIysJBEdAiQIElIJiPUiEqYhiCwaQwwHYiwVDOBOOb9VyGFEzxz3o R6gs0YyDEPDKI0CigK59KzRiE8/RdlKJAtzBFeB75DzQB44AbHEBgxkA4bTyNO0kAHSaW08X0rSp LXiHI+6Ei6ZswRA0JOA5vLEnuvDYA1sUYBWpOGIcAKrHlaRHE5iJECqqh6yeDalYIZwNQ2akB2YB 5Ylj+lloMIOF6fD/k4mHUc4AmPgySfSxPogSYzuamYk+/mRyegQXHATg0ZBQEWusKIQvdnFSUlAp EZoASTbMkI0UHWAVCWjAIh7ET0UZ7lsCKFDU2hA3uERITwu62phk1YsecktMfPoLJ+LBL/ZwKyM3 ndMneEgw8iCKAXTioQHCswZEqYF+NdhbgayqByuZx25zJYz0fMmSWxIjLbP5hj74gBsfAQkZ4TOX uUpwuWuEihzKugWEXEQXTdXke6raEYc+QReIKCd8qpmUizLGIbRMs5TkBAgz0zQPvNJgHgYYFTkU EDZDiI9yL5LTCKxjzdCl4aKAhJ0rtvTW19XHjbGTxMKoVSqA/Ga3/1gpGqpMg0e3PcRqYkoLy6wB oEvF4gHqolwY9ICvNeQrBzfVDx6BqrixPFMrmUvkkKhlRnTCthmXC4nnnra+SOLRJflRmjseRRNZ SlFySMOtZor1G+hqCrn5QtzR/kWwqDYVHuPsQlW8lYMAyzdQoSkO0lahlL/kFpo6omp97FcCxDm0 WgfDiBz0ugv/MgVW67DSKc8T2/dUQgFjVSPKsIWb9kriyAaOSwm8VQkGVJloXWhbGRITwlcJEQdx HQAnwuCeVIyiNqt4gHnkdZKqHcY7+rgRwRIgDZYUJxVMI8yE14E9ZxGVn7XSZX7M4B4BQJJy24hZ F9jb1f2Bd2DVPP9ugkcnAkT1TRK8IZwOviY4d7CIIyBJUDdt5KkYy8dyM40ypDcG3F3gNn6RUVh9 ErM6BL0YDt/IUBhY9i2GABUvhAOpfUnwWpssDKRmONCLxmVqNaBXFrnLaQ44kYrHRSJjlS4nYoTz CFS1rDjm0J4dY6ST4YklUV52B7NLUJDkPgu4BaDGVrgQikqZtNTJgl60q4UGBkSqBIEjtrTt/ZVS FiCy2uAkUYB02e7KwsdCGOQLaEwpFx8SkTSg+A90XArNeJLYmeRBQMArg7+Y0ZUQZ4ocncjymHxZ CN24RAh7II2gKrHlOGfBZIeQs2xkUQdpCHXOh65A2EUcDgXoIg4gsGNbojtdqz8XggPmwQAz6uAA a2n607fO9a57/etMCAEAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/go.gif R0lGODlhHgAVANU/AAAAKgAAOGVloszM4O7u9Xd3rZCQvC0tgRwcdyMje3x8sEBAjbu71j09ioiI uFVVmXh4rgoKbAAAZgAAUgAAWwQEaYWFtlFRlwAAShERcElJkgAAQxERYjAwgjU1hm5uqGlppYKC tKurzIqKuRUVc2JioUZGkDMzhAAAYf///0REj1tbnXBwqUxMlB8feXNzq5mZwlhYm9/f646Ou0RE iF5enm1tp5SUv3FxqhgYdHd3pCsrgOTk74iIsYCAs////yH5BAEAAD8ALAAAAAAeABUAAAb/wJ9w SCwaj8iiAvKyCWqxSzI5coQUBRaotHpcWhpVozMdGhy+wucZ1ZhUi0bDs0tMb2fFp/RgvTQeHYKC B3UIGRVHeBYFAhchPCmSNzkkOQgILi4IJBESFEUzMxYvKyogKTIsLQMpIBUVEbIZGZ4UExtEVjgx DQkyBDkVEgkMBRISJiIMI8IouAFDCgosKwsJCykjyNzIApKSA58YAQAAQjYgKyY7GQopDxInDPQq EgQE9iIpJ7jm5z+6AEIQAUIKewIYEOCnIoUDZA5S0CD3T4iGBR4SICqQQgA3BikkNIQhIYOMFBw2 /AN4ok4nYvgeqICRQty9mgt7UKwopFMFThQUKAhYKImBPXmtCOjYaY7Iz1sTolKgQSMDiqtAb2HY UG5lkQkYtm7YEDaq2bBcu3o1kjaA27dw1a4EiGSu3btlhNzdSzfvkL1+AwcOAgA7 ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: http://www.fda.gov/medwatch/IMAGES/fda_mast_bkgrd.gif R0lGODlhFABGALMAAJmZzDMzZszM/2ZmmTMzmf////8AAMzMzAAAZgAAAAAAAAAAAAAAAAAAAAAA AAAAACwAAAAAFABGAAAETNDISau9OOvNu/9gKGZIaZ5oqq5s675wLM90bd94ru987//AoHBILBqP yKRyuSw4n9CodEqFHq7YrHbL7Xq/4LB4TC6bz+i0es1upyMAOw== ------=_NextPart_000_0000_01C3BF75.2F696120 Content-Type: text/css; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/medwatch/mwstyle.css .mw_style { FONT-FAMILY: Arial, Helvetica, sans-serif; BACKGROUND-COLOR: #ffffff } A:hover { COLOR: #ff0000 } BODY { FONT-FAMILY: Arial, Helvetica, sans-serif } P { FONT-FAMILY: Arial, Helvetica, sans-serif } H1 { FONT-FAMILY: Arial, Helvetica, sans-serif } H2 { COLOR: #ff0000; FONT-FAMILY: Arial, Helvetica, sans-serif } H3 { COLOR: #006600; FONT-FAMILY: Arial, Helvetica, sans-serif } H4 { FONT-FAMILY: Arial, Helvetica, sans-serif } H5 { FONT-FAMILY: Arial, Helvetica, sans-serif } .menu { FONT-WEIGHT: bold; FONT-SIZE: 13px; COLOR: #000000; FONT-FAMILY: Arial, = Helvetica, sans-serif } ------=_NextPart_000_0000_01C3BF75.2F696120--