Franklin's Focus 5/28/10


I am forwarding an email from Worst Pills, Best Pills.
It is an excellent sample of why we need this organization, and why you should consider joining. The membership fee is extremely reasonable, and it takes only a single message protecting you from a dangerous medication you are using to justify the small expense.


Never mind that the FDA has approved of a drug you are taking. It is far more important that it be approved by Worst Pills, one of the most important national organizations known a 'Nader's Raiders' group.


It offers a huge library of information on all drugs sold in this country. Signing on with this organization at their extremely low price is something you must consider. Every time a doctor or dentist prescribes a medication, you can check it out with Sidney Wolfe and his vast resources. He has often fought for years to get a drug off the market, while the FDA has dithered and dithered. We cannot trust the FDA. It's decisions are often political, not scientific. The FDA is a monumental disgrace. They still maintain that tobacco is not an addictive or dangerous drug! There is only one reason for that – huge campaign donations to the weasels on the Hill.


I'm an automatic member, meaning I'm automatically renewed once yearly. That prevents me from failing to renew when a one year membership expires.


I once steered a nurse practitioner to this group, and she tells me it has been a boon. She has been able to steer many family doctors away from dangerous medications by using this resource.


Over the counter medications and cures can be especially risky. Wolfe does not hesitate to steer one to a health food remedy for a problem such as constipation and other extremely common problems. Wolfe often establishes that the cure is worse than the malady.


Big Pharm hates this man more than any other critic in America, and I understand why.


Warmest regards,
Richard


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Begin forwarded message:


From: "Sidney M. Wofe, M.D."
Date: May 28, 2010 11:44:19 AM CDT
To: usereason@earthlink.net
Subject: New Risks Associated with Diet Drug Orlistat (Xenical, Alli)
Reply-To: wpbpsupport@citizen.org






Dear Richard,

Labeling for prescription and over-the-counter (OTC) versions of the diet drug orlistat (Xenical, Alli) is now required to contain new safety information about cases of severe liver injury associated with the use of the drug, according to a May 26 announcement by the Food and Drug Administration (FDA).

The FDA approved 120-milligram pills of orlistat as a prescription drug in 1999 for weight control in conjunction with a reduced-calorie diet. In 2007, a 60-milligram pill of orlistat was approved for OTC use for weight loss in overweight adults in conjunction with a reduced-calorie and low-fat diet. Orlistat in both prescription and OTC form is currently approved for marketing in approximately 100 countries.

In August 2009, the FDA announced it was reviewing safety information regarding reports of liver related adverse events in patients taking orlistat. During this initial review, 32 reports of serious liver injury, including six cases of liver failure, were identified.

The FDA then conducted a complete review of available data on severe liver injury associated with 120-milligram doses of orlistat through August 7, 2009, and a review of post-marketing reports on 60-milligram doses of orlistat from 2007 through October 1, 2008. This final review identified 13 cases of severe liver injury.

Of the 13 cases of liver injury, 12 were reported with the use of orlistat in 120-milligram doses and one was reported with the use of the 60-milligram product. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.

Of the 13 cases, two patients died from liver failure and three patients required liver transplants.

Public Citizen has been concerned about orlistat and opposed to its approval from the very beginning. We testified before the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in May 1997 against the approval of the drug. In 2006, we also testified against the switch to OTC and petitioned for the drug to be banned altogether.

Orlistat was approved without scientific evidence showing that there is a health benefit for those who use it. In other words, there is no evidence that orlistat, or any diet drug, will reduce risk of premature death or illness associated with long-term obesity and inactivity.

What You Can Do

Do not use orlistat. This drug has a meager effect on weight but its potential to cause serious side effects, including pre-cancerous lesions of the colon (aberrant crypt foci), liver damage and pancreatitis, is significant. The most common side effects of orlistat include oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements.

Contact your healthcare provider immediately if you develop any of the following symptoms, as they may signify potentially serious liver problems:

Yellowing of the skin or whites of eyes (jaundice)
Unusually dark urine
Loss of appetite that lasts several days or longer
Nausea
Abdominal (lower stomach) pain
Consumers may report serious adverse events or product quality problems with the use of orlistat to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Regular Mail: Use postage-paid FDA Form 3500. Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: (800) FDA-0178

Phone: (800) FDA-1088



Sincerely,

Sidney M. Wolfe, M.D.
Editor, WorstPills.org