December 27, 2010

By Brian Bujdos

The U.S. Food and Drug Administration (FDA) in November informed RockHard Laboratories that it found an analog of Sildenafil in its “Dietary Supplement” called RockHard Weekend. RockHard Laboratories quickly provided a press release announcing its “voluntary recall” of RockHard Weekend lot numbers T12 705 08, T12 705 09, R417 0509 and T237-0509.

Sildenafil, the active ingredient in the erectile dysfunction medication Viagra, is an FDA-approved drug that’s still under patent, which means RockHard Weekend is illegal in the U.S. RockHard Laboratories did not list the Sildenafil analog in its ingredients, and the drug can cause a sudden and dangerous drop in blood pressure if taken with medications that include nitrates – such as nitroglycerin.

This month, just before Christmas, RockHard Laboratories announced it had found more Sulfoaildenfil (the Sildenafil analog) in other batches of RockHard Weekend, as well as in its Pandora sexual enhancement product (for women). Consumers should also be on the lookout for RockHard Weekend lot numbers 100159, 100260 and 100378, as well as Pandora lot number 100378.

The FDA urges men and women who have these products in their possession to return them to RockHard Laboratories for a full refund due to the fact they are illegal and can cause serious injury or death due to their false labeling.

The FDA has cracked down recently on companies that sell “all-natural dietary supplements” for sexual enhancement/erectile dysfunction. Earlier this month, the FDA told manufacturers of Man Up Now and Duro Extend that their products are illegal because they also contain an analog of Sildenafil.

In the case of RockHard Weekend, the manufacturer maintains that the product will work for 48 hours – that one dose lasts an entire weekend (much like Cialis). The FDA warns consumers to stay away from products that make such promises, because herbal supplements cannot likely have this effect, and they may contain unknown substances that are not listed on their labels.

In its November press release announcing the first recall of RockHard Weekend, RockHard Laboratories used this very interesting language:

“RockHard Laboratories takes the upmost pride in its quality control by outsourcing production to a certified, independent lab. It is through this outside lab that RockHard Laboratories maintains the highest quality standards possible and can quickly take action. RockHard Laboratories has identified that one of the lab’s raw ingredients, sourced from China, was being unknowingly tainted with sulfoaildenfil.”

First off, the ingredients for RockHard Weekend come from China, which is notorious for providing illegal, mislabeled, potentially harmful products such as “generic” Viagra. These products are produced with no oversight or regulation.

Secondly, RockHard Laboratories is apparently not a laboratory at all, as it admittedly outsources production to an independent lab (which we could also assume resides in China). Thirdly, “upmost” is not a word, and if the company did take pride in its products and cared about safety, it would not outsource production or use ingredients from China.

RockHard Laboratories claims on its website that it is located in Atlanta, Georgia. But no address is provided – a sure sign of potential impropriety (how can someone return their recalled medications for a full refund?). For example, AccessRx lists its Arizona address clearly on its website for all to see, because it has nothing to hide.

RockHard Weekend is “Temporarily Sold Out” on its website, and does not even clearly locate the recall information so that its customers, who may have previously bought the product, can be alerted to the safety dangers outlined by the FDA.

Not only that, the RockHard Weekend homepage (see left column) lists what it calls an “important announcement/important retraction” from the September issue of Consumer Reports. The magazine listed RockHard Weekend as one of 12 natural sexual enhancement supplements to avoid because it contains a Viagra-like drug. Consumer reports retracted its statement from the web, only to find out two months later from the FDA that it was correct – RockHard Weekend does indeed contain an analog of Sildenafil.

The important announcement on the homepage of RockHard Weekend is that many of the product’s lot numbers have been recalled.

These are the types of companies and products consumers are trusting with their health, well-being and lives when they buy medications and supplements online. Although Viagra, Cialis and Levitra are more expensive, they are the only FDA-approved medications for erectile dysfunction, and their safety profiles are excellent. Side effects that do exist are typically mild to moderate.

See a more complete list of ED “supplements” that have received warnings from the FDA. When it comes to consumer safety, it’s simply not worth the risk to ingest unknown ingredients from unknown and unreliable sources.

Read more health news articles on AccessRx.com.