Archive for July, 2009

Goodbye to Percocet and Vicodin?

Monday, July 6th, 2009

An advisory panel to the Food and Drug Administration narrowly voted to recommend a ban of two of the most popular prescription painkillers—Percocet and Vicodin—because of harm they can cause to the liver.

Percocet and Vicodin both combine a narcotic (oxycodone in Percocet, hydrocodone in Vicodin) with acetaminophen, a pain reliever commonly found in over-the-counter medications like Tylenol and Excedrin. Acetaminophen is used to relieve headaches and fevers, but is also known to cause liver damage. High doses of acetaminophen are the leading cause of liver damage around the country.

The FDA is not forced to act on the recommendations of the panel, but they usually do. If the FDA does decide to ban Percocet and Vicodin, doctors will still be able to prescribe their contents (the narcotic and acetaminophen) separately. Though doctors have this option now, many opt for the combination drugs because it makes the process of treating pain easier on patients, doctors, and pharmacists.

Generic drug maker cited for defective drugs

Monday, July 6th, 2009

The Food and Drug Administration has seized several plants belonging to the drug manufacturer Caraco Pharmaceutical Laboratories Ltd. for manufacturing violations.

The FDA cited multiple violations of manufacturing standards and seized approximately 33 different generic drugs at three different plants. The FDA will prevent Caraco from distributing anything until they have assurance that the company will comply with FDA standards in the future.

The drugs that were seized were generic forms of heart, pain, and psychiatric medicines. Caraco was accused of poor handling of drug ingredients and varying tablet-manufacturing processes.

People currently taking drugs made by Caraco should not be concerned and should continue to take their medications as prescribed. Any defective drugs should have been weeded out of the market already by recalls.

The seizure of these drugs could cause a shortage of choline magnesium trisalicylate oral tablets. If you are currently taking this medication and experience a supply shortage in your area, talk to your doctor about an alternative drug.

Regulating the Regulators

Monday, July 6th, 2009

Is the Food and Drug Administration properly overseeing the approval and manufacturing of medical devices? This is the question brought by a House Energy and Commerce subcommittee who is seeking legislation to increase oversight of the FDA.

The Congressional subcommittee claims that the FDA has serious deficiencies in their reviewing processes, substandard postmarket surveillance, and that they irregularly inspected manufacturing facilities.

Their basic solution is this—allow consumers to file lawsuits against manufacturers of defective medical devices directly instead of just filing incidences with the FDA. This would prevent companies from being able to hide behind inadequate FDA standards for the products, thus ensuring safer devices.