Follow-Up to Hydroxycut Recall

Margaret Embry — Mon, 18 May 2009 09:41:44 GMT

As a follow-up to the May 1, 2009 Hydroxycut recall post, the FDA has released more information about the recall. As of May 7, 2009,

Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

These additional UPC numbers being added to the May 1st list include:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets

Iovate initiated this voluntary recall after the FDA reported that 23 consumers had experienced liver-related problems, which is different from Iovate's analysis.

Consumers with questions about the recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 Monday through Friday between 9 am and 5 pm Eastern Daylight Time.

Originally posted at InjuryBoard by Margaret Embry

Vytorin Linked to Cancer?

Tara Helms — Mon, 06 Oct 2008 17:33:12 GMT

The FDA is investigating a report of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination of Zocor and Zetia and is generally prescribed to reduce LDL-cholesterol levels. A recent study, however, raises an alarming question: Can the use of Vytorin cause cancer?

A clinical study known as the SEAS trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of major cardiovascular problems. A lower cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of people treated with Vytorin were diagnosed and died from all types of cancer, including skin cancer, when compared to placebo during the 5-year study. The FDA is considering, but has not yet reached a conclusion, about whether this information warrants any regulatory action. According to the New England Journal of Medicine, “it is appropriate to raise a note of caution. Whether the increased mortality risk is due solely to the play of chance is uncertain. Ezetimibe [Zetia] interferes with the gastrointestinal absorption not only of cholesterol, but also of other molecular entities that could conceivably affect the growth of cancer cells.”

According to the FDA website, Zocor, a “statin” class drug approved in 1991, decreases production of cholesterol by the liver and is indicated to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events such as heart attack and stroke. Zetia, approved in 2002, inhibits the absorption of cholesterol in the intestine and is indicated to reduce LDL-cholesterols. Vytorin, the combination product, was approved in 2004 and indicated to reduce LDL-cholesterol levels.

Earlier this year, Vytorin’s effectiveness was called into question. A company-sponsored trial known as the “Enhance” trial was meant to prove that Vytorin’s combination of Zetia and Zocor would reduce the growth of fatty plaque in the arteries more than Zocor alone. Instead, the plaque actually grew almost twice as fast in patients taking the combination drug.

These recent studies raise serious questions: Does Vytorin work? Can it actually put you at higher risk for cardiovascular problems? Does it put you at an increased risk of getting cancer?

Links to NEJM articles:

Change of opinion: http://content.nejm.org/cgi/content/ful...
Full SEAS Vytorin trial: http://content.nejm.org/cgi/content/ful...
Gene damage study: http://content.nejm.org/cgi/content/abs...

Links to Canadian Medical Association Journal article:

http://www.cmaj.ca/cgi/content/full/179...

Originally posted at InjuryBoard by Tara Helms

Huntsville Personal Injury Lawyer - FDA

Follow-Up to Hydroxycut Recall

Vytorin Linked to Cancer?