In its latest press release, the FDA says that P&J TRADING has issued a nation-wide voluntary recall of the company’s dietary supplements sold under the brand name SLIMDIA REVOLUTION. According to the reports from the federal agency the company is issuing the recall after being notified by the US FDA that testing found that certain lots of SLIMDIA REVOLUTION products contain active pharmaceutical ingredient “Sibutramine”.

The above mentioned active pharmaceutical ingredient is a Shedule IV controlled substance and is widely prescribed across the globe as an appetite suppressant. Sibutramine is a FDA approved substance that is used to treat the condition of Obesity. Since the substance comes under schedule IV category it should be taken only under the direct supervision of qualified doctor or health care professional. “Sibutramine” is a drug ingredient that was withdrawn and recalled in United States due to its potential adverse impact on human body. According to the federal agency, Sibutramine is an oral anorexiant that usually comes in the form of hydrochloride monohydrate salt and is being widely prescribed and marketed as an adjunct in the treatment of exogenous obesity along with diet and exercise.

The potentially affected lots of the product were distributed nationwide in US from March 2012 to December 2012. With the notification the manufacturer has also requested customers in possession of the SLIMDIA REVOLUTION products to return any unused product for a full refund to the company directly. Customers can call 714-726-6544 (9am to 5pm, Monday-Friday) for instructions on the return and refund process.

Some side effects that patients can experience with Sibutramine are:

  • Upset stomach
  • Nausea
  • Dry mouth
  • Strange taste in mouth
  • Sudden increased appetite
  • Constipation
  • Trouble sleeping
  • Drowsiness
  • Dizziness
  • Menstrual pain and cramps
  • Joint/muscle pain
  • Headache

According to the FDA the substance sibutramine can potentially increase the pulse rate and blood pressure of the user that may cause serious health injuries. The substance has an inherent tendency to react actively with some other drugs and may lead to devastating consequences. The agency has also warned that patients who are suffering from disease like coronary artery disease, congestive heart failure, arrhythmias, or stroke are more susceptible to adverse reaction with this drug ingredient and hence extra care needs to be taken by such people.

What are Schedule IV Drugs?

Recognizing the fact that certain drugs, chemicals, pharmaceutical ingredients and medications have the potential to cause dependence and subsequently health hazards, US Congress enacted the Controlled Substance Act (CSA) as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. According to the law the drugs and medications that fall under these sections should be taken only under the supervision of a certified medical practitioner.

Some examples of schedule IV drugs are:

  • lorazepam (Ativan)
  • alprazolom (Xanax)
  • diazepam (Valium)
  • clonazepam (Klonopin)