A recent opinion piece in the New York Times calls for more public access to the clinical data that government agencies such as the U.S. Food and Drug Administration use for making policy about medications.
Authors Peter Doshi and Tom Jefferson write that drug or medical device manufacturers are required only to share their data with regulators, who treat the data as secret, and not with independent researchers or academics.
That ...
continue reading...
Officials with pharmaceutical giant Bayer said in a U.S. Securities and Exchange Commission filing that they expect more lawsuits over the company’s Yasmin line of birth control pills, Bloomberg reports. More than 11,000 lawsuits have already been filed over injuries allegedly caused by the drugs.
Last week, the company announced a settlement for about 500 lawsuits related to the contraceptives, which were the first batch of suits scheduled to go ...
continue reading...Bayer will pay at least $110 million, or an average of about $220,000 a case, to settle about 500 lawsuits over claims that its birth control pills caused blood clots, Bloomberg reports.
The lawsuits dealt with the company’s pills containing the compound drospirenone, which include Yasmin, Yaz, Ocella and Beyaz.
According to the Bloomberg report, the settlements came after a federal judge ...
continue reading...Deep-vein thrombosis, or the formation of a blood clot in one of the body’s larger veins, affects an estimated 2 million Americans each year, according to the Coalition to Prevent Deep Vein Thrombosis.
The Coalition provides the following information about the condition:
• Deep-vein thrombosis most often occurs in the lower limbs, including the thigh or the calf.
• Only about half of the people with DVT experience symptoms. Sometimes DVT produces minimal or no symptoms.
• Symptoms of DVT may include pain, tenderness, ...
continue reading...A news report on KOMO, a Seattle TV station, profiles a dental hygienist who suffered a debilitating injury as a result of a blood clot that she attributes to her use of oral contraceptive Yasmin.
Laura Strothers described herself as a “healthy 30-year-old” with no symptoms associated with blood clots, other than her use of the popular birth control pill. After suffering the blood clot, she has to do her work with limited use of her left hand.
“My left arm was ...
continue reading...
A women’s health advocate said she’s afraid the U.S. Food and Drug Administration’s decision to change the warning label on certain types of birth control pills won’t be enough to protect users from the increased risk of blood clots.
On April 10, the FDA announced the label change for birth control pills containing the synthetic hormone drospirenone, including Yaz, Yasmin, Ocella and Beyaz.
The new labels reflect the findings of multiple ...
continue reading...
