Grand Junction Personal Injury Lawyer - FDA & Prescription Drugs

The Heparin Debacle Part Three - The FDA Falls Flat

Linda Snyder — Wed, 30 Apr 2008 06:00:00 GMT

“Protecting and Promoting Your Health.” That’s the tag line posted on the U.S. Food and Drug Administration web site. Protecting and promoting your health, doesn’t seem to have the same meaning to the FDA as it does to the U.S. consumer.

Putting it very simplistically, the FDA is charged with ensuring that the food and drugs we consume are safe before they are made available to the public. Recent news has shown that many of the drugs that the FDA has approved have not only not failed to "protect and promote our health," but in fact have deadly consequences.

Consider these facts:

• FDA approved drugs, Oxycodone, Fentanyl and Clozapine, are on the list of top 10 deadliest drugs and are responsible for over 12,000 deaths from 1998 to 2005.
• The American College of Cardiology has recommended that the popular FDA approved drugs, Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail.
• A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling FDA approved drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

According to a report from the Government Accountability Office, the FDA would need to spend at least an additional $56 million next year in order to fully inspect foreign plants. The FDA would need at least $15 million a year to inspect Chinese drug plants every two years to comply with US standards.

At its present pace, it would take the FDA nearly 27 years to inspect every foreign manufacturer that exports medical devices to the US. It would take 13 years to inspect every foreign drug plant and 1,900 years to inspect every foreign food plant.

Although the Bush administration acknowledges the problem, President Bush’s budget does not provide the FDA with the funds to hire additional inspectors. There are proposals in motion to increase the FDA’s budget and to shift some of the financial burden onto the domestic and foreign manufacturers to pay fees for inspections.

I don’t know about you, but now when I go to my medicine cabinet and take out that bottle of FDA approved prescription medication that I assumed was safe, because the FDA’s motto is “Protecting and Promoting Your Health”, I get a funny feeling in the pit of my stomach that no medication can fix.

Up Next: The Heparin Debacle Part Four – Is Baxter International Getting Away with Murder?

Originally posted at InjuryBoard by Linda Snyder

Fentanyl Tablets Warning From FDA, Cephalon Oncology

Courtney Mills — Thu, 13 Sep 2007 13:28:27 GMT

The FDA has issued on its MedWatch page an announcement about the publication of two "Dear Healthcare Professional" letters from Cephalon Oncology about potential dangers of their fentanyl buccal tablets.

Fentora is manufactured by Cephalon oncology and is indicated in the treatment of breakthrough cancer pains. Fentanyl tablets are not appropriate for patients suffering from post-operative pains, but rather are designated only for those individuals who have exhausted all other forms of opiate therapy and are thus considered 'opioid-tolerant.'

Misapplication of Fentora and general inappropriate prescribing of fentanyl buccal tablets have been associated with severe respiratory depression and death in patients, therefore proper patient selection is paramount to reduce the risk of any catastrophic injury.

If you are taking Fentora tablets, please consult with your physician if you feel that you have been overprescribed, as you may run the risk of an overdose on this potent synthetic opioid.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Courtney Mills

Zelnorm Back on the Market

Jenny Albano — Fri, 27 Jul 2007 13:01:48 GMT

The drug Zelnorm, manufactured by Novatis, was taken of the market in March because of a high risk of heart attacks, stroke, and chest pain. But now the FDA is allowing the irritable bowel syndrome drug to become available again, but only for a restricted access program. Zelnorm will remain off the market for the general public.

The program is for women in the US under 55 years of age who suffer from IBS with constipation or chronic idiopathic constipation, and for whom no other treatment has provided satisfactory relief, or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment.

The drug is back on the market because of complaints from doctors and patients of the Zelnorm's "marketing suspension". But now there are special requirements that have to be met to become a part of the drug's program. Users cannot have any known or pre-existing heart problems and must be in dire need of the drug.

The drug was removed because a review showed that Zelnorm users had a higher incidence of cardiovascular problems than did participants taking the placebo. Novartis claims that there is not causal relationship between Zelnorm and heart attack.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jenny Albano

Public Citizen Alerts Public of Class Action Against Paxil on You Tube

Jenny Albano — Wed, 18 Jul 2007 19:26:05 GMT

Public Citizen, a consumer advocacy group, decided advertise a class action suit a little differently. The group of lawyers used You Tube, a popular video website, to announce a $48 million class action settlement for people who had purchased Paxil for their kids.

There are two videos up on the website. The first video that shows a teenager wandering around looking confused, and then a news announcement about the class action for people who purchased the drug for their children. The video then directs consumers to a website that tells them how to make a claim. The second video is a 7 second video called the Paxil Chipmunk, where there chipmunk looks frightened and then the screen says, "If you took Paxil, you could get $100 or more."

"As long as you're honest about something, why not also be funny," said attorney Brian Wolfman of Public Citizen.

Attorney Dwight Davis, who represented GlaxoSmithKline, said he didn't have a problem with the video as long as it did not imply that his clients had done anything wrong.

"This is a free country and they're certainly free to do something like this," Davis said. But, he added, "if they're suggesting that this child [in the video] is wandering around in a fog because they used Paxil, then we may very well have something to say about that, because that's misleading."

Glaxo did not admit to any wrongdoing, but they ended up agreeing on a settlement to avoid years of litigation.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jenny Albano

Experts say Levalbuterol Inhaler same as Albuterol

Staff Writer — Mon, 05 Feb 2007 10:38:17 GMT

WorstPills.org recommends that patients using levalbuterol (Xopenex HFA) consider using the older and less expensive asthma inhaler albuterol (Proventil, Ventolin).

They also recommend that before stopping use of any drug, you should consult your physician. WorstPills.org reports that levalbuterol does not offer any benefits over albuterol; it just costs more.

The editors of the highly respected Medical Letter on Drugs and Therapeutics, known for their independence from drug companies, first reviewed levalbuterol in 1999. They concluded their evaluation by saying that there was "no clinically significant advantage" over albuterol. Almost six years later, in their March 13, 2006 issue, Medical Letter reiterated those same sentiments in their review of levalbuterol HFA:
There is no convincing evidence that levalbuterol tartrate (XOPENEX HFA) offers any advantage over racemic [a technical term for the mixture of the two isomers of a drug] albuterol.

Originally posted at InjuryBoard by Staff Writer

Drug interactions growing problem for seniors

Staff Writer — Wed, 27 Dec 2006 09:17:34 GMT

As the baby boomer population ages and the senior population continues to grow, drug interactions and overmedicating are becoming bigger problems for the oldest Americans. New services by workingcaregiver.com and others provide pharmacist tsupport to help manage medications among seniors.

A pharmacist expert or specialist can help make sure a patient doesn't experience drug interactions, which can cause serious damage or death.

A press release from workingcaregiver.com out of Austin, Texas details the program's services.

Seniors have more chronic diseases and multiple conditions so they use more prescription and over the counter drugs. Therefore drug interactions are rising. It's an increasing dilemma in America that seniors are taking inappropriate medications for older persons, are not aware which medications to avoid when certain diseases are present, and when medicine hurts instead of helps.

Originally posted at InjuryBoard by Staff Writer

Nice Site For Defective Drugs

Staff Writer — Tue, 17 Jan 2006 08:28:46 GMT

The consumer watchdog group Public Citizen sponsors the website worstpills.org. Worstpills.org provides consumers with unbiased information about prescription drugs and includes news/opinion from Public Citizen as well as from the general media.

Originally posted at InjuryBoard by Staff Writer