FDA Warns Drug Companies to Stop Selling Illegal Narcotics

(www.Borganic.org) The FDA has sent letters to nine companies, warning them to cease all marketing of 14 narcotic painkillers that have not received regulatory approval.

In 2006, the FDA began a program to crack down on the estimated 2 percent of prescription drugs that reach the market without receiving agency approval. The majority of these are generic variations of other drugs already on the market.

All 14 drugs mentioned in the most recent letters are either highly concentrated liquid forms of morphine or immediate-release, fast-acting morphine, hydromorphone or oxycodone pills. The drugs in question were either introduced before the FDA had ruled on the applications to approve them, or were simply introduced without going through the approval process at all.

The FDA decided not to recall any of the drugs, but simply warned the companies that they have 60 days to stop manufacturing the products and 90 days to cease all shipments of them. If the companies do not comply within that time, the agency may seek sanctions such as fines or seizure of the drugs.

The targeted products are all morphine relatives in the opioid drug class. In a press release about the action, the FDA warned that because opioids can produce euphoric feelings and because tolerance and dependence on the drugs can easily develop, abuse potential for them is high. Indeed, narcotic painkillers are among the most common recreationally abused prescription drugs.

Known side effects of opioid use include impairment of motor or cognitive skills, and overdose or other improper use can cause serious injury or illness. In serious cases, death may result, such as from heart attack or cessation of breathing.

The companies involved in the FDA action are Boehringer Ingelheim Roxane, Cody Laboratories, Glenmark Generics, Lannett Company, Lehigh Valley Technologies, Mallinckrodt Inc. Pharmaceuticals Group, Physicians Total Care, Roxane Laboratories and Xanodyne Pharmaceuticals.

After Decades of Doing Nothing, FDA Warns Drug Companies to Stop Selling Illegal Narcotics



Sources for this story include: www.reuters.com.

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