Pharmaceutical Dangers: The Story of Pradaxa

More than 2 million people take blood thinners every year, making this segment of the pharmaceutical market a multibillion-dollar industry and spurring on drugmakers to develop and sell competitive new drugs that bring in profits. Unfortunately, sometimes even after studies show dangerous side effects, a hazardous drug will remain on the market. And it is the consumer who pays the price.

That is the case with Pradaxa, a newer blood thinner that can have debilitating side effects like bleeding accidents, which can be fatal.

A New Blood Thinner 

Blood thinners are used to decrease the risk of heart attack and stroke; help patients following knee or hip replacement surgeries; and treat atrial fibrillation (irregular heartbeat).
For decades, there was only one blood thinner on the market: warfarin.
Pradaxa arrived in 2010, and it has since been used by millions of Americans. With Pradaxa, Boehringer Ingelheim offers patients a blood thinner that is more convenient than warfarin. Pradaxa does not require the diet changes or regular blood tests that warfarin does, and in clinical trials it performed with an equal level of safety and efficacy.
However, Pradaxa has been linked to thousands of adverse events — including severe bleeding events — prompting further evaluation by the Food and Drug Administration (FDA).

Pradaxa Timeline

Oct. 19, 2010: FDA approves Pradaxa for the prevention of stroke and blood clots in patients with atrial fibrillation.
Dec. 7, 2011: FDA reports hundreds of reports of serious bleeding events related to Pradaxa.
March 2012: Two journals publish studies revealing that Pradaxa has a greater risk of heart problems, including heart attacks, than warfarin.
May 31, 2012: QuarterWatch, a publication for the Institute of Safe Medication Practices, issues a report stating that Pradaxa accounted for 3,781 serious adverse events in 2011, including 542 deaths.
August 2012: Federal Pradaxa lawsuits against Boehringer Ingelheim are consolidated into multidistrict litigation in the U.S. District Court for the Southern District of Illinois.
Nov. 2, 2012: The FDA reviews data on serious bleeding events and claims that Pradaxa does not present a greater risk of serious bleeding than warfarin.
Dec. 19, 2012: The FDA informs the public that Pradaxa is not indicated for use in patients with atrial fibrillation caused by mechanical heart valves.

The Future of Pradaxa

Even with Pradaxa’s history of debilitating side effects and litigation, the drug remains on the market. Patients need to be aware of the risks of Pradaxa – specifically, the risk of uncontrollable bleeding. Unlike warfarin, there is no antidote for bleeding caused by Pradaxa. Patients and doctors need to decide whether the benefits of Pradaxa outweigh the risks.
Boehringer Ingelheim is seeking approval from the FDA to expand the use of Pradaxa for patients who have had hip or knee replacement surgery. Any expanded use of Pradaxa could put more patients at risk.

 Alanna Ritchie is a researcher and writer for Drugwatch.com, a consumer advocacy website.
Disclaimer:

This information is provided by Drugwatch.com and is not suitable for professional medical advice, diagnosis or treatment.

Drugwatch.com is wholly responsible for this article, and should any third party wish to discuss or have concerns over any part of this article, we may be contacted at: webmaster@drugwatch.com

Northwest Online Pharmacy joins forces with American Drugwatch.com

Medical Specialists Pharmacy, the leading online pharmacy with doctors based in the North West, has teamed up with several UK Media Houses and America’s well known Drugwatch.com to produce and bring valuable information about drugs to the online population via its in-house medical news team.

In 1994, Medical Specialists came about because entrepreneur and Managing Director David Bailey had a vision of online medication. The company has progressed since and become the first online clinic in 2001. In 2010, Medical Specialists became the first online Pharmacy with Doctors, meaning you could have an online consultation with one of their in-house Doctors who could then produce a digital prescription, which would be dispensed by one of their in-house Pharmacist, and the medication with you within 24 hours, either at your home, place of work or other nominated delivery point.

This year saw Medical Specialists Pharmacy as one of the first online NHS Pharmacies offering the new EPS2 system, which means your own GP can send paperless digital prescriptions direct to them. Medical Specialists Pharmacy can then dispense your NHS medication via Royal Mail Special Delivery to the patient the very next day, and once again either at your home, place of work or other nominated delivery point. See www.medical-specialists.co.uk for further information.

A News Team was set up to report on new drugs, problem with drugs and medication, or other interesting medical news. The team has grown over the years, and is now producing a number of stories each day for publication on the internet. This has become a great source of interest by the online public and the media, and they have been approached by a number of UK Media Houses and America’s well known Drugwatch.com. The two latest stories, ‘Bladder Cancer Linked to Type 2 Diabetes Drug’ and ‘Brits Risk Eyesight as Survey Reveals Majority in the Dark’ being some of them.

Managing Director David Bailey said, “We are constantly being approached to produce stories regarding certain subjects, and have also been approached by Drugwatch.com to publish certain stories of theirs appertaining to side effects of specific drugs. Also, several UK Media Houses have approached us with a view to publishing stories for their clients. If we feel the stories are suitable, then we are willing to consider publishing them.”

He went on to say, “We have also been approached by a number of small television production companies regarding very specific medical problems such as Erectile Dysfunction and Hair Loss with a view to making programmes, but at this moment are unable to give further information, so…watch this space!”

Bladder Cancer Linked to Type 2 Diabetes Drug

From nearly the moment it was invented, the type 2 diabetes drug Actos has been linked to bladder cancer. During the drug’s clinical trials, bladder tumors showed up in male lab rats. Once the drug was released to the public, the disease started showing up in Actos patients. Yet, despite these Actos complications, the drugs’ sales shot through the roof.

With the help of tiny font, glitzy advertising and the downfall of its main competition, Actos rose to stardom, and the bladder cancer risk went largely unnoticed for years. By the time researchers had definitive proof, Actos had a hold on the market and the drug was established as a household name.

Actos Moves In

It began in 1999 when the U.S. Food and Drug Administration (FDA) approved Actos for sale. The active ingredient, pioglitazone, works by making the cells more receptive to insulin, a key component to type 2 diabetes control. While Takeda was trying to establish Actos as the go-to drug, another drug in the same family, GlaxoSmithKline’s type 2 diabetes drug, Avandia, was having its own problems.

At the time, Avandia was on the top of the type 2 diabetes drug food chain — that was, until it was linked to heart problems. Seeing their chance, Takeda executives pushed Actos as a safer alternative. The public bought into it.

Soon Actos owned the diabetes market. Doctors, convinced that Actos was a safer medication with few or no side effects, wrote millions of prescriptions – more than 100 million prescriptions globally by 2011.  Patients trusted it.

Actos-Bladder Cancer Link Revealed

While all this maneuvering was going on, Actos had a secret in plain sight. Written in tiny font on the drug’s label, Takeda revealed that the medication was shown to cause bladder tumors in male rats.  Even though the FDA knew of the risks, most of the public did not. The FDA ordered Takeda to launch a 10-year investigational study into the link at the same time the drug was made publically available. In 2007, Takeda said the initial results of the study showed that those taking the drug for longer than a year had 40 percent increased risk for bladder cancer.  About the same time, drug regulators in Germany and France revealed similar findings from their own Actos study. Some European countries banned or restricted the drug’s sales. The FDA’s response was to only added more wording to the drug’s label, underscoring the bladder cancer risk.

Actos Collapse?

Today, Actos has fallen out of favor with physicians and patients. Doctors don’t want to prescribe it, and patients don’t trust it. While the Takeda-run study won’t be completed until 2013, the latest independent study shows that Actos increases the bladder cancer risk up to 80 percent. At the same time, a whistleblower has accused Takeda of orchestrating the downfall of Avandia to promote Actos and skewing the FDA data to make the drug seem safer.
What’s left are the patients who are left diseased and worried after taking Actos? Many have started filing Actos lawsuits, against Takeda.

Disclaimer:-

This information is provided by Drugwatch.com and is not suitable for professional medical advice, diagnosis or treatment.
Drugwatch.com is wholly responsible for this article, and should any third party wish to discuss or have concerns over any part of this article, we may be contacted at: webmaster@drugwatch.com