Drug Companies Hide Trial Results

Dear Reader,

Everyone who takes a prescription drug is stepping into the unknown. I mean EVERYONE. Including your doctor.

Your doctor MIGHT have a clue about the drugs he's prescribing. But that's the best you can expect. A clue.

That's because almost nobody outside of the inner circle of drug company employees gets a complete look at drug company trials.

Here's how trial transparency crusader Dr. Ben Goldacre puts it in a recent New York Times article… If you flip a coin, but hide it every time it comes up tails, it looks like the result is always heads.

Silence is golden

FDA says Zithromax can cause fatal irregular heart rhythm

Reuters/Reuters - A woman walks past the Pfizer Inc. headquarters in New York, January 31, 2013. REUTERS/Brendan McDermid

(Reuters) - The U.S. Food and Drug Administration warned on Tuesday that the popular antibiotic azithromycin, sold as Zithromax, can cause a potentially fatal irregular heart rhythm in some patients.

The agency said the move follows its review of a study by medical researchers as well as a company study assessing the drug's potential for causing abnormal changes in the electrical activity of the heart.

Last May, a study in the New England Journal of Medicine compared the risk of cardiovascular death in patients who took Zithromax with those who took several other antibiotics, including amoxicillin. It found that patients who took Zithromax, made by Pfizer Inc, had higher rates of fatal heart rhythms.

Night Bullet: Recall - Undeclared Drug Ingredient

ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night Bullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.

The following product lot is being recalled: B43N032, UPC code 018505122233, Expiration Date 10/2015. These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions and they may seek products to enhance sexual performance. Sildenafil may also cause side effects such as headaches and flushing.

Magic Power Coffee: Potentially Dangerous—Not Magical

Consumers should not use an instant coffee being sold online as a dietary supplement for sexual enhancement, warns the Food and Drug Administration (FDA).

The product, Magic Power Coffee, contains a potentially dangerous ingredient. The product is sold in a two-serving box as well as in a carton that contains six two-serving boxes.

FDA’s lab analysis determined that Magic Power Coffee contains a chemical similar to the active ingredient in the prescription drug Viagra to treat erectile dysfunction. The chemical may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

Although Magic Power Coffee is labeled as an “all natural dietary supplement,” it can cause serious harm. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

Public Notification: “Hard Ten Days” Contains Undeclared Drug Ingredient

[2-18-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Hard Ten Days,” a product for sexual enhancement sold on various websites.  FDA laboratory analysis confirmed that “Hard Ten Days” contains sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).  


Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (See label)

Public Notification: “Man King” Contains Undeclared Drug Ingredient

[2-18-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Man King,” a product for sexual enhancement sold on various websites.  


FDA laboratory analysis confirmed that “Man King” contains sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (See Label)

Public Notification: Rock Hard Extreme and Passion Coffee Contain Undeclared Drug Ingredient

[12/30/2010] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Rock Hard Extreme and Passion Coffee, products promoted and sold as dietary supplements for sexual enhancement. 


These products are promoted and sold on various websites, such as www.drivetotalenergy.com,  and possibly in some retail stores.

FDA laboratory analysis confirmed that Rock Hard Extreme and Passion Coffee contain the undeclared ingredient sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).