Classified by the FDA as a drug, Mirena is a contraceptive administered as a hormonal IntraUterine Device (IUD). It is inserted into the uterus as a long-term contraception. Manufactured by Bayer Healthcare, Mirena was approved by the FDA on December 6, 2000 as a contraceptive. It is the only hormonal IUD that has FDA approval. It was designed for long-term application. After insertion, this T-shaped polyethylene device prevents pregnancy by releasing a synthetic version of progestin hormone for up to five years. According to claims made by Bayer Healthcare, Mirena is more than 99% effective at preventing pregnancy, which would place it as one of the highest ranking contraceptives for effectiveness. However, Bayer offers no data in support of this claim. In October of 2009 Mirena was also approved for treatment of heavy periods involving heavy and excessive menstrual bleeding in women with at least one child birth. As of 2011, more than 15 million women have used Mirena IUD
When the FDA released its own study that showed Actos can increase the risk of bladder cancer, it caused two foreign governments – France and Germany – to ban the drug outright, but it has never left the shelf in the U.S., where it is now being unleashed in generic form.
The Food and Drug Administration has approved the first generic version of the type 2 diabetes drug Actos, which will make the popular and controversial drug available at a lower price, hence likely to be taken by more and more diabetics. Mylan Pharmaceuticals will manufacture the first generic form of Actos in 15-, 30-, and 45-milligram doses.
NaturaLyte and GranuFlo, used in dialysis, appear to increase the risk of heart attack. On March 29, 2012, all Fresenius Medical Care (FMC) Naturalyte and Granuflo dialysates products were the subject of a class I FDA recall, which included all products manufactured since 2008. The FDA is also investigating whether the company’s failure to warn patients violated federal law. It appears now that Fresenius Medical Care (FMC) failed to alert the public to the GranuFlo heart attack risk for several months after first discovering the increased heart attack risk.
Do FDA administrators work for the public whom the agency is entrusted to protect, or pharmaceutical corporations who count on FDA approval? If they work for the public, why are they spying on their own scientists when those scientists raise questions about drug safety and the agency’s approval processes? The New York Times reported in July 2012 that the FDA conducted a vast surveillance operation against a group of its own scientists. Records that were accidentally released show the agency captured thousands of e-mails that concerned FDA scientists sent congressional members, lawyers, labor officials, journalists, and even President Barack Obama.
A transvaginal mesh recall could be the opening gong of the death knell for the plastic mesh catastrophe unfolding across the nation. At the very least, transvaginal mesh (TVM) litigation took a step forward for plaintiffs this week when Johnson & Johnson’s Ethicon division informed the FDA that it intended to recall four of its Gynecare products: the Prolift Kit, Prolift +M Kit, Prosima Kit and TVT Secur.
The announcement is the latest in a series of troubling developments that began in July last year when the FDA reported a five-fold increase in deaths, injuries and/or malfunctions associated with transvaginal mesh (TVM) used in pelvic organ prolapse repair (POP) procedures. That report was followed in September 2011 by an advisory panel which urged the FDA to reclassify mesh products as “high-risk.” Then in January 2012, the FDA ordered several manufacturers to conduct further studies regarding the “side effects” and complications associated with their products.
The U.S. Food and Drug Administration has issued a recall of Thoratec Corp’s HeartMate II pump after it was found that a critical part of the surgical procedure was left out of the instructions. This error could lead to serious side effects or even death.
The missing step might cause detachment of the bend relief from its intended position around the proximal outflow graft, which could allow the graft to kink of deform, resulting in reduction of blood flow from the pump, according to the Food and Drug Administration.
The Food and Drug Administration released a safety alert regarding a higher risk for blood clots in women taking birth control pills containing Drospirenone, such as Yaz and Yazmin.
As a result of the alert, Bayer must revise Yaz and Yasmin labels to include the new FDA warning. The new labels must report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products, according to the FDA. The labels will also include a summary of the previously released results of an FDA-funded study of the blood clot risk.
High doses of Celexa, an antidepressant, might cause dangerous abnormalities in the electrical activity of the heart, according to the U.S. Food and Drug Administration.
The Celexa drug label has been altered to contain the caution that needs to be taken when patients with certain underlying heart conditions use citalopram. The revised label also advises that lower doses be taken in patients over the age of 60.
Electrical activity changes of the heart can lead to the risk of fatal abnormal heart rhythm. Due to this risk, health care providers might need to regularly monitor the heart in patients that use Celexa. The FDA says the maximum recommended dose of Celexa is 20 mg per day for patients over the age of 60.
The FDA has released a drug safety communication regarding the use of the blood thinning medication, Pradaxa.
According to the FDA, serious bleeding events have occured after the use of Pradaxa. See the FDA Drug Safety Communication below:
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events
Millions of Americans take statins for heart disease prevention. The FDA has released new important safety information regarding these cholesterol-lowering medications.
According to the FDA, some brain-related impairments, such as memory loss, forgetfullness and confusion has been reported by some statin users. The FDA also reports that statin users face a potential increased risk of higher blood sugar levels and the development of Type 2 diabetes.
The FDA will be updating the package insert of some statin products to communicate these new concerns.