Huntsville Personal Injury Lawyer - FDA & Prescription Drugs

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

The FDA Warns Consumers to Stop Using Hydroxycut Products

Tara Helms — Fri, 01 May 2009 13:21:14 GMT

The FDA is warning consumers to immediately stop using Hydroxycut products. Some Hydroxycut products are associated with a number of serious liver injuries. The manufacturer, Lovate Health Sciences Inc. of Oakville, Ontario has agreed to recall Hydroxycut from the market. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

The FDA has received numerous reports of serious health problems ranging from jaundice and elevated liver enzymes to liver damage requiring liver transplant. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis (a type of muscle damage that can lead to other serious health problems such as kidney failure). The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

The list of products being recalled by Lovate currently includes:

Hydroxycut Regular Rapid Release Caplets

Hydroxycut Caffeine-Free Rapid Release Caplets

Hydroxycut Hardcore Liquid Caplets

Hydroxycut Max Liquid Caplets

Hydroxycut Regular Drink Packets

Hydroxycut Caffeine-Free Drink Packets

Hydroxycut Hardcore Drink Packets (Ignition Stix)

Hydroxycut Max Drink Packets

Hydroxycut Liquid Shots

Hydroxycut Hardcore RTDs (Ready-to-Drink)

Hydroxycut Max Aqua Shed

Hydroxycut 24

Hydroxycut Carb Control

Hydroxycut Natural

Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax (800-FDA-0178) or phone (800-FDA-1088).

Originally posted at InjuryBoard by Tara Helms

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

FDA Links Botox to Adverse Reactions and Death

Tara Helms — Wed, 02 Jul 2008 11:34:07 GMT

Botox (Botulinum toxin) has become well known for its use for cosmetic purposes in smoothing wrinkles. Botox, however, has been linked to cases of serious adverse reactions, including death, according to the Food and Drug Administration (“FDA”). The FDA notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked to respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

Botox (type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and excess sweating. Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in facial lines and wrinkles. Myobloc (type B) is approved for the treatment of adults with cervical dystonia. The safety and effectiveness of Myobloc for cervical dystonia in children have not been proven.

The most severe adverse reactions were found in children treated for spasticity in their limbs associated with cerebral palsy. The adverse reactions appear to be related to the spread of the toxin to areas away from the site of injection, and mimic symptoms of botulism. Symptoms of botulism may include difficulty swallowing, weakness and breathing problems. Some patients with difficulty swallowing have required feeding tubes. Also, some patients with breathing problems were unable to breath without the assistance of a ventilator. Serious outcomes included hospitalization and death.

Consumer rights groups have asked the FDA to add the strongest warning, a black box, to the products’ label. These groups have also asked that patient-friendly medication guides be developed alerting patients to the earliest signs of an adverse reaction. However, the FDA has indicated that a black box warning is premature at this time.

Until the FDA has completed its review, the FDA has warned patients and healthcare providers to be alert to the potential for adverse reactions following the administration of Botox. The FDA also advises patients who have received Botox to receive immediate medical attention if they have unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness. The FDA also asks patient to report adverse events to FDA’s MedWatch reporting system.

Originally posted at InjuryBoard by Tara Helms

Serious Health Risks Associated with Bowel Cleansing Products

Tara Helms — Wed, 21 May 2008 17:20:58 GMT

In recent years, the use of oral sodium phosphate solution (Fleet Phospho-Soda) as a bowel preparation for colonoscopy or surgery has become more and more common. The U.S. Food and Drug Administration issued an alert in May of 2006 noting that “a rare, but serious form of kidney failure has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-Soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. Some of these products (Fleet Solutions) may be purchased over-the-counter and are commonly used by individuals for pre-colonoscopy and pre-surgery bowel cleansing. Other products (Visicol tablets and Osmo Prep tablets) may only be obtained by prescription. Although Osmo Prep tablets were not included in the FDA alert, there is still a risk associated with the use of this product and kidney damage.

Acute renal failure involving calcification of renal tissue has been identified. It is believed that the manufacturers of these products failed to properly warn about the potential side effect of kidney failure which has been associated with these products. A large percentage of the individuals who have suffered kidney failure as a result of ingesting these products have become dialysis dependent, and in some cases, the kidney failure has resulted in death.

Originally posted at InjuryBoard by Tara Helms