State of Connecticut Medicaid Program to Receive Part of GSK Settlement

GlaxoSmithKline will pay Connecticut $1.72 million as part of a larger nationwide settlement related to selling tainted, sub-standard and defective prescription drugs.

Related to a post earlier this week regarding GSK's huge financial settlement, the money will be paid to Connecticut's Medicaid program as a small fraction of a $750 million overall settlement.

"GlaxoSmithKline's dumping of defective drugs on Connecticut Medicaid recipients is shocking and shameful," said Attorney General Richard Blumenthal. "Such a massive failure to follow formulation and sanitation standards is unacceptable and inexplicable. The company endangered patient health -- and pumped up profits -- by providing tainted tablets."

GlaxoSmithKline allegedly sold four drugs to Medicaid that were contaminated at the company's plant in Cidra, Puerto Rico. Those drugs were:

-Paxil CR, an antidepressant that had either no active ingredient or only the active ingredient without the controlled-release aspects of the pill.

-Avandament, a diabetes medication that had too much or too little of the active ingredient.

-Kytil, an anti-nausea drug that had some impurities.

-Bactroban, antibiotic ointments and creams that contained microorganisms.

The company's head of global litigation, Elpidio Villarreal, said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes."

Secure Pharma Chain is noticing an influx of quality control or poor manufacturing issues that are not just related to overseas contract manufacturing.

The dangers that these incidents pose to consumers all over the globe are serious and significant.

It is important that all members of the pharmaceutical supply chain authenticate and verify the quality and efficacy of their inventories to avoid liability and to protect their individual brands.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

FDA Expands List Of Tainted Weight Loss Pills

This past week, the U.S. Food and Drug Administration (FDA) expanded their list of tainted weight loss pills. Originally in late 2008, FDA warned consumers about 28 products which contained undeclared pharmaceutical ingredients and were marketed for weight loss. This list has since been updated twice. This latest update brings the total to 72 products, some of which are marketed as dietary supplements.

"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."

The active pharmaceutical ingredients contained in the products but not identified, the FDA said, include:

• fenproporex -- a controlled substance not approved for sale in the United States
• fluoxetine -- an antidepressant available by prescription only
• bumetanide -- a potent diuretic available by prescription only
• furosemide -- a potent diuretic available by prescription only
• rimonabant -- a drug not approved for sale in the United States
• cetilistat -- an experimental obesity drug not approved for sale in the United States
• phenytoin -- an anti-seizure medication available by prescription only
• phenolphthalein -- a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for sale in the United States

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

According to the FDA, these products are marketed at websites, convenience stores and some beauty shops. Consumers are encourage to discontinue their use and report any side effects to the FDA MedWatch website at www.fda.gov/MedWatch/getforms.htm

A complete list of the tainted weight-loss products is available at the FDA.