Public Citizen calls for FDA to pull J&J’s birth control patch
WASHINGTON The consumer advocacy group Public Citizen petitioned the Food and Drug Administration yesterday to take Ortho-Evra, Johnson & Johnson’s birth control patch, off the market, saying that its far riskier than the pill, according to the Associated Press.
Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills because they absorb up to 60 percent more estrogen than pill users. The FDA did update Ortho-Evra’s label in 2005, 2006 and earlier this year with clot warnings.
Sidney Wolfe of Public Citizen argued in the letter that the patch offers no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson researchers that found higher estrogen exposure from the patch even before it won FDA approval in 2001.
Gloria Vanderham, a spokeswoman for patch maker Ortho Women’s Health & Urology, said “Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling.”
“Hormonal birth control methods have benefits and risks,” said Vanderham. “The approved labeling has always stated the known risks associated with its use.”
The FDA told the AP it has not had an opportunity to review the petition and, when it does, it will respond directly to Public Citizen.
Anthem BC/BS allows doctors to access EMRs via cell phone
MANCHESTER, N.H. Anthem Blue Cross and Blue Shield in New Hampshire has unveiled new technology that will enable physicians to have secure access to online patient medical records and claims information from their mobile phones.
“Now all licensed New Hampshire practitioners who are part of our e-prescribing program are also able to access both medical records and claims data on Anthem members, anytime, anywhere by using their web-enabled cell phone,” said Richard Lafleur, medical director, Anthem Blue Cross and Blue Shield in New Hampshire, who added that participants could also access the new program from their office or home computer.
The addition of the new technology, known as Member Medical History, further enhances the e-prescribing tool by delivering an unprecedented amount of clinical information to the physician wherever he or she may be. Now the doctor looking to generate an electronic prescription is able to quickly access their Anthem patient’s medical history, getting valuable information on medical conditions and the patient’s most recent care, test results, or diagnoses by other clinicians.
“Putting even more comprehensive information in the physician’s hands at the time care decisions are being made improves quality and efficiency,” said Charles Kennedy, vice president of health information technology for Anthem. “E-prescribing and MMH are good examples of how Anthem can use technology to create a community benefit for all patients while still delivering unique value for our members.”
Study shows metformin as effective as insulin injections during pregnancy
BOSTON According to a new study, metformin, the generic version of Bristol-Myers Squibb’s diabetes drug Glucophage, is just as effective as insulin injections in treating women who develop diabetes during pregnancy, researchers in New Zealand and Australia reported yesterday.
Gestational diabetes appears in 1-in-20 pregnant women, and there has been concern that metformin might affect a fetus because the drug can cross the placenta.
But the study, led by Janet Rowan of the Auckland City Hospital in New Zealand, found that the risk of complications such as respiratory distress, birth trauma and newborn hypoglycemia, or low blood sugar, was no different for the 363 women who received metformin and the 370 given conventional insulin shots.
After delivery, nearly 77 percent of the metformin recipients said they would want to stay with the pill if they developed diabetes during pregnancy again, even though 46 percent still needed supplemental insulin injections at some point. On the other hand, only 27 percent of those who got insulin shots felt the same way.
But doctors may still be cautious, the researchers said. “Clinicians may remain circumspect about using metformin until follow-up data for offspring are available,” they wrote. The children born during the study are being tested when they reach their second birthday.