Archive for the 'Safety' Category

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.

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.

New adverse side effects found in Tarceva use

Tuesday, May 19th, 2009

The Food and Drug Administration has released warnings about the possibility of serious injuries and even death caused by the cancer-treatment drug Tarceva. Generically known as erlotinib, Tarceva is administered as a once-daily pill taken by the patient on an empty stomach. It is intended to block tumor growth in lung and pancreatic cancer patients.

Serious injuries now associated with Tarceva are fatal holes in the gastrointestinal tract, toxic epidermal necrolysis (blistering and separation of the top layer of skin), corneal perforations, and eye ulcerations.

Tarceva is manufactured by Genentech Inc. and OSI Pharmaceutical Inc. The FDA approved Tarceva in 2004 to treat locally advanced lung cancer and metastatic non-small cell lung cancer.  In 2005, Tarceva was approved to treat locally advanced pancreatic cancer when used in combination with gemcitabine.