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.

Zicam Nasal Products Found to Cause Loss of Smell

Monday, July 6th, 2009

The Food and Drug Administration (FDA) has issued a public health advisory stating that the use of Zicam Cold Remedy nasal products should be stopped.  The nasal products are used to help with cold symptoms.  They contain zinc and have been found to cause anosmia.

Anosmia is a condition where the victim loses their sense of smell and partial sense of taste.  The FDA has received more than 130 reports linking the loss of smell to Zicam since 1999.  They are recommending that these products be thrown away immediately.

The products manufactured by Matrixx Initiatives that have been targeted include:
•    Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
•    Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
•    Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

Better Contact Lens Safety on Agenda for FDA

Monday, July 6th, 2009

About three years ago, ReNu with MoistureLoc contact lens solution was linked to a medical condition called Fusarium Keratitis.  It is an infection in the eye that is very serious and potentially blinding.

The contact lens solution was recalled from the U.S. in April of 2006 after about 180 cases of Fusarium Keratitis were confirmed.

Other contact contact lens solutions have also been recalled in the past.  Advanced Medical Optics (AMO) sold Complete MoisturePlus solution in 2007.  The solution was linked to 21 cases of infections and the company recalled the product.

Now, the Food and Drug Administration ( FDA) is trying to make the public more aware of the safety precautions that should be taken when dealing with contact lenses.  Earlier this year, they hosted a workshop called “Microbiological Testing of Contact Lens Care Products,” to make a method to test contact lenses and solutions.

There was also a meeting in June 2008 where recommendations were made for the labeling of contact products.  In addition to the expiration date, companies had to also put a discard date on the bottles of solution.  This date is when the bottle should be thrown away after being opened.

The FDA sent out letters to solution manufacturers who added an option of cleaning lenses without rubbing.  The letter stated that there is an improvement in safety when the lenses are rubbed and rinsed instead of just rinsing alone.

Along with the letter, the FDA has made a new video on contact lens safety.  The video can be seen of the FDA website.  Some main points in the video are completely emptying the contact lens case after each use, using the rub and rinse method, use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use, and do not expose contact lenses or lens storage cases to any type of water of non-sterile solution.