A case was recently reported of a 70-year-old man who developed rhabdomyolysis after his Lyrica (pregabalin) dosage was increased and he was also given Zocor (simvastatin), a statin drug usually given for high cholesterol. Rhabdomyolysis is the breakdown of muscle fibers that leads to the release of muscle fiber contents (myoglobin) into the bloodstream, which is harmful to the kidneys and often causes kidney damage.
When he arrived at the emergency room, the man was mentally disoriented, he was unable to stand up, all four extremities were twitching and he had slurred speech. Other symptoms of rhabdomyolysis may include:
Dark, red or cola colored urine
Decreased urine production
Muscle stiffness or aching
Weakness of affected muscles
Unintentional weight gain
Statin drugs are known to sometimes cause rhabdomyolysis. Lyrica is not generally recognized as a cause of rhabdomyolysis, although in t...
Two weeks ago I told you that the FDA approved a generic version of Lyrica ® (pregabalin) made by Lupin Limited, but I wasn't able to find out when it might actually be available on the market. Now I know why I couldn't find that information. Apparently Lupin was awaiting a court decision as to whether or not on Pfizer Inc.'s patents for Lyrica were valid.
That decision came down last Thursday, July 19, 2012. Judge Gregory M. Sleet of the U.S. District Court of Delaware upheld the validity of Pfizer's patents for Lyrica, giving them exclusive rights to the medication until December 30, 2018. In addition, Judge Sleet ordered the FDA to stop approving generic forms of pregabalin until Pfizer's patents expire.
The Story Behind the Decision
In 2009, Pfizer filed a lawsuit charging patent infringement against Israel's Teva Pharmaceutical Industries, India's Sun Pharmaceutical Industries, and U.S. firms Mylan and Watson Pharmaceuticals, who all sought FDA approval ...
As of this writing, three medications have been approved by the FDA for the treatment of fibromyalgia: Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). Since all three are relatively new drugs, information on how well they work and their side effects is still being gathered. Because every patient's symptoms and body chemistry are different, it is often a matter of trial and error to find the best medication for a particular patient with a particular illness. However, a recent German study , which was the first to compare the pros and cons of the three drugs head-to-head, may help doctors choose which medication has the best chance of success for any given patient. Study Design The study authors searched MEDLINE, SCOPUS, Cochrane Central Register of Controlled Trials, and sought unpublished data from the databases of FDA, US National Institutes for Health, and Industry through May 2009 for randomized controlled trials. They found 17...
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