Ketoconazole-Anti Fungal Medication Should Not Be Distributed

A consumer advocacy group has asked the FDA to immediately withdraw oral formulations of a decades-old fungal medicine over concerns that serious liver damage outweighs “questionable” benefits. And to reinforce its assertion, the consumer group cites an internal FDA memo in which agency staffers two years ago wrote that they did not view the risks associated with ketoconazole as “tolerable.”

The medicine was approved in 1981 to treat various fungal infections and several generic versions are currently available, although the original brand-name medicine is no longer sold. In its petition to the FDA, however, Public Citizen notes the FDA required a so-called black box warning – the most serious safety alert – for the drug in 1983 due to potentially fatal liver damage.

By July 2013, growing concerns prompted the FDA to issue a safety notice that removed several approved uses from the product labeling because of the risk of liver injury, adrenal gland dysfunction and troubling interactions with other medicines. The agency allowed oral versions of the drug to remain available for five fungal infections in the event other treatments fail or are not tolerated.

On the same day, though, the European Medicines Agency recommended all oral formulations be removed from the market over concerns about liver damage. The EMA review committee “could not identify a fungal infection where the level of hepatotoxicity of the drug could be balanced by an adequately substantiated benefit,” according to its report.

What was not previously known is that in January 2013, 14 staffers in the FDA Office of Surveillance and Epidemiology wrote a memo that the “overall benefit-risk assessment… is negative in the context of all of the drug’s labeled indications.” The 48-page review was undertaken after French regulators in 2011 suspended marketing authorization for the tablets due to safety concerns.

“The FDA’s own experts concluded that ketoconazole was too dangerous to remain on the market for any of its approved uses, yet the agency continues to allow hundreds of thousands of prescription for the medication to be filled each year,” says Sammy Almashat of Public Citizen in a statement. The consumer group says 462,000 prescriptions were written in 2014, citing IMS Health data.

An FDA spokeswoman would only say that the agency “will review the petition and respond directly to the petitioner.” We asked the three generic drug makers that sell ketoconazole in the U.S. – Teva Pharmaceuticals, Mylan Laboratories and Taro Pharmaceuticals – for comment, but no one has responded.

Health Canada VS FDA Did They Really Think They'd Win?



Whatever the FDA told Health Canada has had an effect. Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.

Health Canada initially responded to the FDA putting Apotex's finished dose plant in Bangalore, India under import alert by asking the company to quarantine products manufactured at the facility. The quarantine bought Health Canada time to learn why the FDA issued the import alert and formulate its own response. Six days after calling for the quarantine, Health Canada has banned the import of 30 finished products--and a similar number of APIs--that Apotex manufactures at its Bangalore plants.

The regulator has also banned almost 20 APIs--and 50 products in which they are used--from IPCA Laboratories. A common thread links the regulatory actions: Data integrity. "This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products," Canadian health minister Rona Ambrose said in a statement.

Reports of data integrity failings at IPCA emerged after FDA visited a plant in July and issued a Form 483. Staff at the IPCA site allegedly falsified temperature records, tweaked integration parameters and overwrote raw data. FDA inspectors visited Apotex around the same time, leading to a warning letter detailing the discarding of undesirable assay results and other data integrity problems.

Elderly Overmedicated--When Will This Abuse Stop



Elderly pay the price once again for someone's greed!

NPR (9/5, Jaffe, 519K) reported in its "Shots" blog that a Federal lawsuit against two California nursing homes accused of overmedicating patients may offer a new approach to dealing with the persistent problem of such facilities overmedicating their residents."

 The US Attorney for Northern California "claims that the two nursing homes provided 'grossly inadequate, materially substandard and/or worthless services,'" while they "received about $20 million from Medicare and Medicaid for those services."

 Kelly Bagby, a senior attorney with the AARP Foundation, said, "Under the False Claims Act, the government can ask for triple damages."

Omni Pharmaceuticals Famous for their Pharmaceuticals or Famous for their Kickback payouts!

 

 

Omni Pharmaceuticals was ordered to pay $124.24 million to resolve the issue of them paying kickbacks to secure contracts to nursing home facilities for deep discounts. We are the ones whom are affected indirectly. By companies like this being corrupt and overcharging Medicare and Medicaid will eventually have the trickle down effect by increasing premiums for these programs. Let's be honest when you get to the point in your life that you qualify for these services is it fair that you are overcharged so some CEO can have a couple extra vacations. If these practices continue without consequence there will soon be  point when these programs are omitted as an option. Have you ever witnessed this kind of selfishness in your company? What would you do if you were given this information? Would you have the courage to come forward or would you be like the majority of workers and look the other way so your paycheck isn't jeopardized? I say we owe our thanks to the people who have had the backbone to stand up for what's right in America today!!

 

Since January 2009 The Justice Department has recouped more than $13.9 billion in cases involving fraud against federal healthcare programs. The impact of these false claims if not exposed will continue to impede on our society forever. If you have any questions or would like more information please contact Jim Vander Linden today! (612) 339-6841. http://www.vanderlindenlaw.com

 

 Do you think your clinic or dr. would ever prescribe something for you only to get a kickback from the manufacturer? It's a terrifying thought isn't it, but truth be told it happens everyday. If you know of fraud on any level happening in your area it really is your responsibility as a citizen of the community to stop it TODAY!