Pain Doctor: No Need to Suffer. Pain Center of Orlando

FDA Acts Against Unapproved Narcotic Drugs

FDA Acts Against Unapproved Narcotic Drugs

By John Gever, Senior Editor, MedPage Today Published: March 31, 2009 .

SILVER SPRING, Md., March 31 -- The FDA has taken steps to pull 14 unapproved painkillers containing immediate-release morphine sulfate, oxycodone, and hydromorphone from the market. The agency has warned nine companies that make the unapproved products to stop manufacturing them within 60 days and to cease distribution within 90 days. Among the drugs affected by the enforcement action are two branded products containing morphine sulfate and oxycodone (Roxanol and Roxicodone, respectively) as well as generic versions of the three painkillers. All the affected products are tablets or oral solutions. Oxycodone capsules were not among the products targeted in the action, Deborah Autor, J.D., director of the compliance office in FDA's Center for Drug Evaluation and Research, emphasized at a press briefing today. Extended-release opioids were also unaffected by today's action. Patients who have been taking the unapproved medications are urged to seek prescriptions for equivalent or similar approved products. "We believe [the action] will not disrupt patient care," Autor said. She said some patients may have to switch to products not exactly identical to the unapproved drugs. Seven of the letters cited immediate-release 20 mg/mL morphine sulfate solutions. There is no approved version of morphine solution at that concentration, although 20 mg/5 mL is available. Autor said supplies of alternative products were sufficient to replace the unapproved products, even though immediate-release oxycodone appears on the FDA's most recent drug-shortage list, updated March 25. "There will be no shortage for consumers," she said. The companies told to pull their products are Mallinckrodt, Boehringer Ingelheim Roxane, Roxane Laboratories, Glenmark Generics, Lannett Company, Lehigh Valley Technologies, Physicians Total Care, Xanodyne Pharmaceuticals, and Cody Laboratories. Autor said the companies must submit responses to the warning letters within 15 days or face sanctions. At a press briefing announcing the action, Autor said the companies may seek approval for the products, but in the meantime they still must be pulled from the market.

Lake Mary Life Magazine Article 3/1/09

Focus on Pain Center of Orlando
Peter Reilly

Chronic pain is the symptom that your body is out of balance. At the Pain Center of Orlando, Dr. David Klein works to restore hormonal and nutritional balance as well as to relieve pain.

He has helped many headache, hand-, foot- and back-pain sufferers regain their health, taking great satisfaction in curing those who have sought treatment elsewhere and haven’t found relief.

“I want to see the patients who are not satisfied with their care, those who have not found relief elsewhere,” he says from his Longwood office, the walls of which are lined with bookcases and decorated with models of antique cars and motorcycles. “I want the ones who are not getting better. I want to see the patients that no one else can figure out.”

With prior training and experience as an analytical chemist, and with nearly 30 years of clinical experience in medicine, a specialty in anesthesiology and with the subspecialty of pain medicine, Dr. Klein, a Longwood resident, is prepared to diagnose and deal with just about any pain-related disorder. He spent seven years as a Navy physician and five years in the Air Force as a flight surgeon, both on active reserve.

Dr. Klein earned his medical degree from the University of Maryland School of Medicine, surgical internship at University of North Carolina, and residency at Duke University. He has served on the clinical teaching faculties of Ohio State University, the National Naval Medical Center, and Portsmouth Naval Hospital, as well as on many editorial review boards for medical journals.

Certified by five medical boards, the doctor has given countless lectures, invented several medical products, and has been published more than 100 times.

With a resume like that you’d think Dr. Klein would be part of a large assembly-line practice with a big staff of nurses and physician’s assistants, but the decorated Gulf War veteran is a sole practitioner who doesn’t rush through visits or overbook appointments.

“There are no physician assistants or nurses in this office,” he says. “I see every patient, every visit, every time.” In fact, Dr. Klein feels that the only way to correctly diagnose what’s wrong is to spend a lot of time with each patient. Pain medicine is one of the most complicated and detail-oriented specialties in medicine.

“You have to look at the entire person to find the cause of his or her pain, or lack of sleep, or whatever the symptom happens to be,” he says.

His practice attracts patients from all over the country, with some coming from as far away as Europe and China. He has treated everyone from diabetics with nerve pain to colitis sufferers with cramping using his unique approach. In addition to traditional treatments, he finds that many pain sufferers are helped with nutritional supplements and hormone replacement therapy.

“Two-thirds of what I do is actually hormone replacement and nutrition,” says Dr. Klein, who was the reserve flight surgeon to the VIP squadron at Andrews AFB under President Reagan. “When you provide the appropriate nutritional intervention, you may need some prescription medications, but you need far less than are traditionally prescribed to get the job done.”

Dr. Klein believes that many chronic ailments result because people are overweight, but undernourished. Americans take in more than enough calories, but don’t get enough of the right vitamins and minerals. The minerals, in particular, are lacking in what we eat. To deal with this, he offers a line of very specific and focused nutritional products through his practice. “One size does not fit all,” he says.

Lifestyle, age, and genetics can also knock a person’s endocrine system out of whack, causing hormones like testosterone, estrogen, insulin and cortisol to become unbalanced.

“You begin with these common health problems,” he says. “But you can correct them with bio-identical hormone replacement, but it must be done precisely and properly. The safety of my patients is most important. I’m here for one reason, to help them get better. (For more information on this subject, check out Dr. Klein’s column on page 92.)

The Pain Center of Orlando is located at 225 West S.R. 434, Suite 205 in Longwood. For more information or to schedule an appointment, call 407-679-3337 or visit Dr. Klein’s informative website at www.suffernomore.com

The Case of the Elderly Acrobat

The case of the elderly acrobat

An 84 year old man presented with the diagnosis of ‘sciatica’ following a fall, two weeks before Christmas.  He was visiting family in Oklahoma when he hit a patch of black ice.  His legs went up in the air as he bell backwards landing flat on his back, ankles over ears.  This man, a tradesman before retirement, was not muscular, but was more flexible than most.  He brushed himself off and thought nothing of it until the next morning when the pain in his back awakened him.

His visit to the local ER resulted in radiological evaluation which demonstrated the anticipated arthritis, desiccated disc and mild osteopenia.  No surprises there.  Other than thyroid replacement and medications for blood pressure and angina, he was quite healthy.

The pain in his back, radiating to the lateral thigh and down to the calf suggested something a bit more sinister.  Being a typical man, and consummate weekend warrior, he chose to wait a while before seeking additional medical attention.  He traveled to and from Oklahoma again, and the pain worsened to the point where he found himself using a fitted cane.  Now that he was having difficulty sleeping, he was time referred for evaluation and treatment of spinal trauma.

Physical examination was entirely unremarkable except for an area of exquisite tenderness in the inferior-lateral border of the Posterior Superior Iliac Spine.  It was only tender if the patient was in the standing position, leaning forward.  Pressure there not only caused him to shout, but it reproduced the ‘leg giving away,’ and initiated pain in the lateral calf.

Superior Gluteal Neuralgia

The diagnosis of Neuralgia of the Superior Gluteal Nerve (SGN) was entertained and treatment was initiated.  A simple peripheral nerve block of the SGN was performed. Moments later, the patient was able to stand, walk and move about without pain at all.  The cane was no longer necessary, at least for 6-8 hours, anyway.  Treatment with oral NSAID’s was initiated (meloxicam 7.5 mg) , and high-concentration 40% transdermal MSM  (Kinkease® Stages of Life, Inc. was prescribed. The patient was scheduled for follow-up in 2 weeks.

Return visit revealed a patient able to sit without pain and ambulate without a cane. The ‘sciatica’ which was not sciatic at all, has all but abated.  Still a bit tender, a second nerve block was performed to ‘seal the deal,’ clinically.  Superior Gluteal Neuralgia is quite common in clinical practice.  Pain with sitting, leaning forward and driving is typical.  Referred pain to the groin, flank and calf can be expected. Physical examination is the essential tool in diagnosis, and diagnostic-therapeutic nerve block will be a life-changing intervention for these patients.

 

David S. Klein, MD, FACA, FACPM

www.suffernomore.com