This is pretty serious. The FDA just announced that there is a big problem If you take the anti-clotting drug Plavix in addition to the stomach acid reducer Prilosec. It turns out that Prilosec cuts the effectiveness of Plavix by half. For people with blood clotting problems, that’s really bad.

The official announcement says… “patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

The science behind it is pretty straightforward. “Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.”

But it’s not just Prilosec that causes problems with Plavix. Others on the hit list are… “Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).”

The good news is that … “Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids [that] do not inhibit the CYP2C19 enzyme aren’t expected to interfere with the anti-clotting activity of Plavix.”

Here’s the link to the official FDA warning here.

To me, a “Dietary Supplement” is a glass of OJ with my eggs. Some bacon in my Whataburger. Things you actually consume with a meal as part of a meal to enhance said meal.

Having said that, I still fail to see how something called “RockHard Weekend” from RockHard Laboratories has anything to do whatsoever with “Dietary Supplement”. It’s either that or I’ve been doing something horribly wrong for breakfast, lunch and dinner this whole time.

The FDA announced that “RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found… sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug.”

In other words, just like the “stiff nights” recall, “RockHard Weekend” has some prescription-based ingredients that they tried to slip under the radar.

The FDA’s justification for the recall is the same one they used on the “stiff nights” recall. It might kill you! Maybe.

“The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may 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 consumers may seek these types of products to enhance sexual performance.”

Here’s the link to the official FDA recall notice.

This is a strange one. Mostly because of the veeeery carefully selected wording in the recall release.

Cardiac Science Corporation announced today that is “is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt.”

Lots of adjectives back yonder. The release continues…

“Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.”

Most of the remainder of the recall is pretty straightforward. That is until you get to the last paragraph. Put your waders on for this next part. It’s deep.

“This press release contains forward-looking statements. The word “believe,” “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.”

Looks like the legal team got to slime this one before it got out the door. Sad.

Anyhow, here’s the link to the official recall NOT FORWARD LOOKING but MAYBE IT IS FORWARD LOOKING notice.