The FDA will put a new warning on the Ortho Evra birth control patch in order to warn consumers and healthcare professionals that users may be at a much greater risk of blood clots when using the patch.
Dr. Daniel Shames, director of the FDA’s division of reproductive and urologic drug products, says updated labeling has been approved for the product to warn healthcare providers and patients that women who use it are exposed to to higher levels of estrogen than most birth control pills.
Drug Products
Website My Space fun for Kids but a Boon for Predators
The popular social networking website My Space, has experienced unprecedented growth in recent months. Kids and teens spend hours browsing the website talking to friends and meeting new ones. However, parents must be aware that sexual predators are using the site to make contact with these kids. As is typical with sexual predators, they use websites popular with teens in order to strike up relationships with them. I urge any parents with teenaged children to monitor their computer use and beware of this looming threat.
Ortho Evra Patch Maker Says Blood Clot Risk Doubles with Birth Control Patch
Women who use the Ortho Evra birth-control patch face twice the risk of developing blood clots as those who take the Pill, the patch’s manufacturer said late Thursday, citing recent company-funded research.
The finding comes from one of two studies comparing the patch and Pill, said Ortho Women’s Health & Urology, maker of the once-a-week patch, based in Raritan, N.J.
FDA: Certain Parkinson’s Drugs Lead to Greater Risk of Gambling
The FDA is reporting that certain drugs used to treat tremors associated with Parkinson’s disease actually increase the risk of pathological gambling. The latest results are consistent with earlier observations and add to evidence that Parkinson’s drugs may lead to impulsive behavior as they make up for depleted dopamine, a brain chemical whose deficiency marks the disease. The researchers found no reports of gambling problems for patients taking antipsychotic drugs, which inhibit dopamine.
“Black Box” Drug Warnings Often Ignored by Healthcare Providers
In a Wall St. Journal article published today, many patients are told to use drugs with black box warning in spite of these drugs being unsuitable for them.
FDA Official Says Vioxx Maker Merck Had Plenty of Time to Warn Patients of Danger
Merck could have immediately warned Vioxx patients that the drug might cause an increased risk of heart attacks rather than waiting two years before issuing a warning, according to a former FDA official.
Health Experts: FDA Oversight Needs to be More Open and Transparent
The chairman of an outside committee of medical experts that advises the Food and Drug Administration on drug-safety issues said Friday the agency’s own drug-safety oversight board needed to be more open and transparent. The chairman of the committee recommended that the FDA add new members to its oversight board.
FDA Panel Recommends Black Box Warning for Certain ADHD Drugs
In a surprise move, a Food and Drug Administration advisory committee voted to recommend that stimulant drugs widely prescribed for attention-deficit hyperactivity disorder carry strong “black box” warnings about potential cardiovascular risks.
FDA Warns Doctors About Trasylol
The FDA has issued a warning to doctors and patients about the adverse risks associated with the Bayer drug Trasylol. The drug is used to control bleeding in such surgical procedures as heart bypass surgery. The FDA highlighted two studies published last month, including one in the New England Journal of Medicine, which showed that the drug, sold under the brand name Trasylol, doubled the risk of kidney failure.
St. Pete Roof Collapse Reveals Cracks in Inspection System
When the torrential rain came pouring down in Tampa Bay last Friday, few thought that a Bed, Bath, and Beyond roof would collapse. According to an article in the St. Pete Times, a contractor got a permit to put a new roof on the building last April 4th but the construction was never inspected by the city.