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.
The European Medicines Agency said on June 21 that it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions dating from 1997 to the present. Among that alarming number of failed assessments were 15,161 deaths, which may have been due to the progression of natural diseases, but may have included deaths connected to Roche drugs.
Roche said that despite its failure to properly investigate the 80,000 adverse event reports, there is no evidence (regarding that failure) of a negative impact for patients. Neither, of course, is there any evidence that the company’s failure to investigate the 80,000 has NOT resulted in a negative impact for some patients.
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.
Takeda Pharmaceutical Company’s new diabetes treatment was not approved for sale in the United States, as U.S. regulators asked for more information on the medicine than other countries.
The Food and Drug Administration requested information through a letter, according to Takeda. The company responded by stating that the necessary data can be supplied from information collected outside the U.S. and from patient studies already under way.
The drug, known chemically as alogliptin, is used to treat type-2 diabetes. The rejection of the drug slows down Takeda President Yasuchika Hasegawa’s plan for it to become the new revenue generator when Actos loses patent protection in four months. The initial rejection took place in 2009 when the FDA asked for more information on cardiovascular risks associated with use of the drug.
Johnson & Johnson .1 Billion in Risperdal Case">and its subsidiary, Janssen Pharmaceuticals, received a $1.1 billion fine by an Arkansas judge for allegedly lowering the profile of the risk of certain side effects in off-label uses and hiding risks associated with Risperdal, an antipsychotic drug. The ruling could affect dozens of pending lawsuits concerning the drug. This verdict is one of many brought against the pharmaceutical giants by state governments. Additional lawsuits are pending in other states.
Circuit Judge Tim Fox ruled Janssen Pharmaceuticals Inc. and Johnson & Johnson must pay $5,000 each for 240,000 Risperdal prescriptions paid for by the state Medicaid program during a three and one half year span. He also fined the companies an additional $2,500 for more than 4,500 letters Janssen sent to Arkansas doctors, totaling more than $11 million.
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 United States Food and Drug Administration released a safety announcement stating possible risks associated with using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney impairment.
The combination of these drugs should be avoided in patients with diabetes. The FDA is adding a new warning stating that patients with kidney impairment should avoid the use of these drug combinations as well, according to preliminary data from the clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”
Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
The United States Food and Drug Administration recommends that users of drugs containing 80 mg of simvastatin watch their intake of the drug, due to a risk of muscle injury. 80 mg is the highest approved dose of this cholesterol lowering statin.
The FDA stated that the dose should only be taken by patients who have been taking it for one year or more with no ill effect.
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.
The top medical-device regulator of the Food and Drug Administration believes the agency needs more power to block unsafe products. Doing so could prevent more of the faulty hip implants and vaginal mesh that have caused thousands of patent lawsuits, according to Bloomberg News.
Legislation was passed in February allowing the FDA to reject devices that were designed based on products recalled for safety flaws in the past. In many cases, the FDA lacks proper authority, which takes away from the credibility of some device approvals, according to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.