FROM OUR EXPERTS
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 ...
It has been about ten years since the United States Drug Enforcement Administration (DEA) launched what some feel is a targeted war on drugs, the battleground being your Doctor's office. The DEA feels there has continued to be a diversion of prescription narcotics for use on "the street." I am not sure this is what they had in mind for Main Street.
The focus on physicians is perhaps the least resistant path to the easier drug bust; after all, physicians are supposed to maintain records of prescriptions written, and document the reasoning behind and the plans for the continued use of a prescription drug. That drug dealer out on the street is a tougher collar.
Physicians have been put through the wringer of the American judicial system, on charges ranging from drug dealing to murder, charges rooted in the over-prescribing of narcotic medications. There is a certain irony here, as such woes have befallen physicians in parallel with the development of drugs that have all...
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