View Single Post
Old 11-11-2005, 05:12 AM   #1 (permalink)
maleficent
Junkie
 
Moderator Emeritus
Location: Chicago
Birth Control Patch Users...

Warning issued about birth-control patch
Quote:
AP) -- The makers of a popular birth-control patch warned millions of women Thursday that the patch exposes them to significantly higher doses of hormones and may put them at greater risk for blood clots and other serious side effects than previously disclosed.

The warning from Johnson and Johnson subsidiary Ortho McNeil, makers of Ortho Evra, says women using the patch will be exposed to about 60 percent more estrogen than those using typical birth-control pills because hormones from patches get into the bloodstream and are removed from the body differently than those from pills.

Thursday's warning comes four months after reports that patch users die and suffer blood clots at a rate three times higher than women taking the pill.

Citing federal death and injury reports, The Associated Press found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems.

Ortho McNeil spokeswoman Bonnie Jacobs said Thursday that the warning speaks for itself and that the company has been cooperating with the Food and Drug Administration, which distributed the new warning to health care providers.

More than 4 million women have used the patch since it went on sale in 2002. Several lawsuits have been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned.

Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was "too high a chance that study may not produce a positive result for Evra" and there was a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen."

Last week, in response to questions about the Ortho McNeil memo, company spokesman Michael Beckerich said in a written statement that "decisions to fund studies are based upon scientific merit."

Beckerich said Ortho McNeil is conducting its own epidemiological study "designed with input from the FDA and similar to those previously conducted with the Pill."

Although the patch and most birth-control pills contain the same amounts of estrogen, new published studies show that women using the patch absorb about 50 percent more estrogen than with the pill, said Dr. Leslie Miller, an associate professor of obstetrics and gynecology at the University of Washington.

When women take the pill, the medication is absorbed into the bloodstream through the digestive tract. In the process, about half of the estrogen dose is lost.

Hormone levels in women on the pill are highest one or two hours after taking it, Miller said. Twelve hours later, estrogen levels are quite low, meaning the body is not exposed to high levels of estrogen 24 hours a day.

But the patch causes higher estrogen levels since delivery of medication continues all day. Those elevated levels may be high enough to increase some women's risk of blood clots, Miller said.

"If the patch is delivering too much estrogen, then it may need to be redesigned," Miller said. "Women should not just take off their patch; they risk pregnancy. If they are worried and want to change off the patch, they can wait to get something else."

Jennifer Cowperthwaite, 26, of Broad Brook, Connecticut, still suffers breathing problems after a blood clot reached her lungs two years ago while using the patch. She said the warnings were long overdue.

"I wish I had known," she said. "It's quite likely I would never have used it."

Erika Klein's sister Kathleen Thoren died a year ago from blood clots in her brain that the coroner said were brought on by Ortho Evra. She said women deserve to be informed when making birth-control decisions.

"Women have a right to know the true risks and make their decisions based on that information," she said. "No one should have to go through what my sister went through."
Now sure how many of y'all are users of the birth control patch, but this is good information for you to have..
__________________
Free your heart from hatred. Free your mind from worries. Live simply. Give more. Expect less.
maleficent is offline  
 

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360