Hyperdrive 3.0 Recall for Sibutramine
Dietary Supplement Venom Hyperdrive 3.0 Contains Undeclared, Controlled Drug – FDA Issues Warning
February 6, 2009 — After testing by the Food and Drug Administration’s Center for Drug Evaluation and Research found sibutramine in Venom Hyperdrive 3.0, the Food and Drug Administration (FDA) issued a warning on January 29, 2009, strongly urging consumers to discontinue taking the dietary supplement. Sibutramine, which was not listed as an ingredient on the product’s packaging, is a Schedule IV controlled substance. Those who take it may run the risk of becoming addicted or abusing it. Taking dietary supplements or medical drugs such as Meridia®, an FDA–approved drug to treat obesity, containing sibutramine may lead to potential health risks.
Dietary Supplements Not Under Same Regulations as Other Drugs
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers are responsible for ensuring their products are safe. Unlike prescription and over–the–counter drugs, dietary supplements need not be registered with or get approval from the FDA before being manufactured and sold to the public. DSHEA does require that the product labels be truthful and not misleading to consumers.
Applied Lifescience Research Industries, Inc. (ALR Industries), the company who marketed Venom Hyperdrive 3.0, did not declare sibutramine as an ingredient on the packaging of the dietary supplement. Since sibutramine is a newly approved drug and is not considered a dietary supplement, any products containing it are required to be submitted to the FDA before marketing. After the FDA found sibutramine in Venom Hyperdrive 3.0, ALR Industries voluntarily initiated a recall of the product.
Health Risks Associated with Sibutramine
Sibutramine may cause high blood pressure, seizures, tachycardia (rapid heart beat), heart palpitations, heart attack or stroke. Individuals particularly at risk are those with a history of the following:
- Hypertension, especially those whose hypertension is uncontrolled or poorly controlled
- Coronary artery disease
- Congestive heart failure
- Arrythmias
- Stroke
- Seizures
- Hepatic dysfunction
Others who may run a higher risk of side effects are those who have narrow angle glaucoma, are predisposed to bleeding, or taking medication affecting homeostasis or platelet function. Those who take the following drugs may also have an increased risk of developing side effects when taking products containing sibutramine:
- Sumatriptan
- Dihydroergotamine
- Dextromethorphan
- Meperidine
- Pentazocine
- Fentaryl
- Lithium
- Tryptophan
- MAO inhibitors
If you have taken Venom Hyperdrive 3.0, the FDA strongly recommends that you contact your healthcare professional and stop taking the product immediately. To report any serious side effects you may have experienced, either you or your healthcare professional may contact the FDA’s MedWatch Adverse Event Reporting program through their online form, by regular mail, fax or phone. See the FDA’s warning for details on the reporting process.
Legal Recourse for Consumers
The attorneys at Brayton Purcell feel very strongly about ensuring the health and safety of consumers. If you feel that you have been harmed by Venom Hyperdive 3.0 or other unsafe dietary supplements and medical drugs marketed without proper testing or misleading labels, please contact our attorneys. We will evaluate your case free of charge and explore your legal options with you.
