On the heels of the five extremist judges on the Roberts’ Supreme court voting last summer to shield multi-national generic drug makers from injury lawsuits brought by Americans (Pliva v. Mensing) comes more evidence to show how ill-informed that decision was. The FDA last week asked Teva Pharmaceuticals to withdraw its generic drug Budeprion XL 300. Testing showed this drug did not release its key ingredient in the expected amounts. Budeprion XL 300 is supposed to be equivalent to GlaxoSmithKline’s popular antidepressant Wellbutrin XL, which is prescribed to treat depression, anxiety and nicotine withdrawal.
Generic equivalency to brand name drugs is not a question the high court considered before ruling against citizens’ safety. It’s worth noting the FDA said this is only the third time in the last five years it has recalled a generic for equivalency issues, but many Americans know from experience that some generic drugs simply don’t work the same way or as well as the brand-name drugs. Nevertheless, insurance companies will often pay only for the generic if a generic is available. That means people are being forced to take a drug from a company that is no longer responsible for it. And eighty percent of the drug prescriptions filled this year were generic.
For more, see “Defective generic pill revives quality concerns” – click here.
It took the FDA four years to finally ban a substance (BPA) in infant food packaging that has long been known to cause brain damage in developing infants and young children. Industry so controls the U.S. government agency that it took a lawsuit from the National Resources Defense Council to finally force the FDA to rule this summer to ban Bisphenol A (BPA) in infant food packaging. One can only wonder how many babies and infants were developmentally damaged in the interim. Because BPA is also known to cause hormonal problems and worse in adults, it is widely banned in most first-world countries; but in America, where FDA staff enjoy a revolving door relationship with industry, BPA is still widely used in many packaged goods.
The NRDC first filed a petition with the FDA in 2008 requesting that BPA be banned in food packaging, containers and any other material used in packaged food. When the FDA failed to respond for two years, as required by law, the NRDC was forced to sue the agency in 2010. NRDC had to petition the court to demand a response. When the FDA finally did respond, in July 2012, it was forced to rule on the science and ban BPA from infant food packaging. Meanwhile, BPA is still free to disrupt adult hormones and damage adults’ health.
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.