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FDA Causes Pain Killers Scare

The FDA has added warning labels to some commonly used pain relievers like ibuprophen and naproxen, warning that use of these NSAIDs (non-steroidal anti-inflammatory drugs) increase the risk of heart attacks.

But according to Curt Furberg, M.D., Ph.D., from Wake Forest University School of Medicine, the FDA has ignored the most dangerous of these drugs, Voltaren, and incorrectly labeled naproxen, which appears to be safe based on research.

Ibuprofen

High doses (500 mg twice daily) of Aleve were not associated with an increased risk of heart attacks compared to a placebo. High doses of Advil (800 mg three times a day) and Voltaren (75 mg twice daily) were associated with rates of heart attack that were 51 percent and 63 percent higher, than the placebo. The increased risk of heart attack is associated with drugs that are COX-2 inhibitors.

“Naproxen does not increase the risk of heart attacks and ought to be a painkiller of choice,” said Furberg. “On the other hand, Voltaren carries the same risk as the harmful COX-2 inhibitors Bextra® and Vioxx®, which have been taken off the market.

Read more at Wake Forest University Baptist Medical Center.

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FDA Warning on Internet Drug Sales

The FDA has issued another alert to consumers about purchasing drugs via internet websites after a number of consumers received drugs containing haloperidol, a powerful anti-psychotic.

Drugs

Consumers who placed orders for specific drugs - Ambien, Xanax, Lexipro and Ativan - instead received products that contained the haloperidol, a drug used to treat schizophrenia. Reports show that several consumers suffered symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and sought emergency medical treatment.

The FDA wants to caution consumers about the dangers of ordering prescription drugs online and states that consumers should consult the FDA website before buying medication over the Internet.

Photos of the of the tablets in question and the shipping packages can be seen here.

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The Parkinsons Patch

Experts in the treatment of Parkinson’s Disease are hopeful that the FDA will grant approval for a transdermal rotigotine patch that will be marketed under the name Neupro. The patch is already being sold and used in Europe.

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The patch provides for a continuous, steady delivery of a drug shown to be effective in 48% of all Parkinson’s patients.

The results of a six-month study of the effectiveness of the patch will be published in the January 23 issue of the journal Neurology.

Parkinson’s Patch Nears U.S. Approval - WebMD

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Acetaminophen Warning

The FDA has announced a voluntary recall of acetaminophen caplets by Perrigo Company. Pills being screened through a metal detector showed that some had metal fragments embedded in them. The discovery was made by the company during quality control procedures and was caused, apparently, by the premature wearing out of a machine used in the manufacture of the caplets.

Bottles

The FDA states that it is not expected that serious injury or complications will arise from the consumption of the pills, but someone swallowing an affected caplet might experience stomach discomfort and minor cuts and scrapes to the mouth or throat.

Perrigo Company makes the 500mg acetaminophen caplets that are packaged and sold as store brands by many major chains, among them Wal-Mart and CVS. A full list of the stores to which the product is distributed is available at this FDA web page. Batch numbers of the approximately 11 million bottles affected by the recall can be found here.

The recall only affects the 500mg dose. If you think you may have some of the contaminated pills, discontinue use immediately. Lower dosage acetaminophen pills are not affected and are safe to consume.

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