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FDA and Drug Makers Target Unapproved Medications

by Toby Roberts on December 30, 2009

In 1938 federal law began requiring that new drugs be approved for safety prior to marketing. In 1962 the laws required that drug makers also prove the effectiveness of new drugs before they could be introduced to the market. The FDA reported in 2006 that several thousand drugs are available that preceded these laws and that are currently still sold without any FDA approval.

In recent years the FDA has been targeting these medications and asking drug makers to submit new formulas for review to replace the previous prescriptions. Drug maker URL Pharma has been working with the FDA to produce a new and approved version of its drug Colchicine (used mostly to treat gout). While the FDA and URL Pharma tout increased public safety, critics claim the move is bad for consumers since it results in dramatically increased prescription prices. [click to continue…]


FDA Targets Medication Usage Errors

by Toby Roberts on November 6, 2009

This week the FDA launched a program aimed at reducing the number of injuries caused by preventable medication errors. The FDA is currently working with the Centers for Disease Control and Prevention to come up with accurate estimates of the number of deaths due to medication misuse.

A large area of concern is the possible interactions of over the counter medications.  On the heels of the reexamination of the appropriate 24-hour dosages of acetometaphine, the FDA wants to focus on informing consumers of appropriate dosages and making those dosages easier to determine. New guidelines have recently been issued for medications that come with measuring devices such as cups or droppers.

The Safe Use Initiative is aimed at cutting in half the estimated 100,000 hospitalizations that occur each year from accidental and intentional misuse of medication. The hope is that by combining consumer education efforts with examination and revision of package and instructional standards the potential for misuse will drop dramatically.


Feds hand down new OTC label regs

by Toby Roberts on May 22, 2009

Though the GAO recently decided not to create a third-drug class for OTC medications, Food and Drug Administration (FDA) has issued a ruling that OTC pain medications made from acetaminophen and NSAIDs (nonsteroidal anti-inflammatory agents) need to have a new warning label regarding potential overdose complications.

Although consumers view acetaminophen as relatively harmless, accidental overdose is the most common cause of acute liver failure in the United States. It also accounts for over 10,000 emergency room hospitalizations and 100 deaths per year.

The most common cause of accidental overdose is consumers who are taking multiple medications that contain acetaminophen. Many consumers are unaware of the variety of pain relievers (both prescription and OTC), and cough and cold medications that contain acetaminophen. When a patient is only taking one type of medication it is easy to track the “do not exceed” amount but when multiple medications are used (as is common in cold/flu season) the safety thresholds can be exceeded in much less than a day. Patients who are taking both prescription and OTC medications are at a higher risk since most fail to consult their pharmacist before purchasing OTCs for minor ailments such as a headache or cold.

The new label is designed to warn consumers about the potential for liver damage from acetaminophen and stomach bleeds from the NSAIDs that may occur even if the recommended dosage is not exceeded. The ruling requires a bold label identifying the risks for consumers and clearly identifying the main ingredient in the medication. The label may appear on the bottle itself or on the outer packaging, depending on how the medication is shelved. The labels are required to be changed by April 2010.


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