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Posts Tagged ‘Medicine’

FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

Posted by 4love2love on July 24, 2011

FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” says Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma. “Lazanda, which uses our patented PecSys® drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”

Breakthrough pain in cancer (BTPc) is an intense, sudden pain that is often unpredictable and debilitating and occurs despite otherwise appropriate opioid therapy for background pain. BTPc has a different profile from background pain. BTPc often has high intensity, a rapid onset, usually reaching maximum intensity within five minutes, and a short duration, lasting between 30 and 60 minutes per episode. On average, BTPc affects more than half of patients with cancer and often interferes with patients’ health and ability to engage in daily living activities.

“As the first fentanyl nasal spray in the U.S., Lazanda provides a new approach to managing the often debilitating and inadequately-treated episodes of breakthrough pain that many patients with cancer experience,” said Donald Taylor, M.D., director at Taylor Research LLC., and clinical investigator for Lazanda. “Current treatment options typically utilize short-acting oral opioid medications that cannot provide pain relief with an onset of action or duration of effect that matches the time course of a BTPc episode. Lazanda’s rapid and controlled availability is a much better match for the nature of an episode of breakthrough pain, giving physicians a new and powerful tool for treating cancer breakthrough pain.”

Lazanda will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.

“We fully support the FDA mandate to implement a REMS program for Lazanda as an important way to provide patients, healthcare providers, and pharmacists with the information they need about the appropriate and safe use of Lazanda,” said Buchalter. “Archimedes Pharma looks forward to working closely with health care professionals to ensure safe and consistent access to Lazanda for the patients who are seeking relief from unbearable episodes of breakthrough pain in cancer.”

About Lazanda (fentanyl) nasal spray

Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma’s patented drug delivery system, PecSys®.

Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.

The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity difference at 30 minutes (SPID30). More than 500 patients evaluated in the clinical trial program (which included three phase III clinical trials) contributed to the understanding of the tolerability and safety profile of Lazanda. The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.

Important Safety Information

Warnings: Potential for Abuse and Importance of Proper Patient Selection

Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the potential for abuse when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.

Lazanda is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Lazanda is contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to Lazanda. Patients beginning treatment with Lazanda must begin with titration from the 100 mcg dose. (see Dosage and Administration)

When dispensing, do not substitute a Lazanda prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetics of Lazanda compared to other fentanyl products that could result in clinically important differences in the rate and extent of absorption of fentanyl and could result in fatal overdose.

Special care must be used when dosing with Lazanda. If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose of Lazanda. (see Dosage and Administration)

Lazanda is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Patients and their caregivers must be instructed that Lazanda contains a medicine in an amount that can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Lazanda must be kept out of the reach of children at all times. (see Patient/Caregiver Instructions)

The concomitant use of Lazanda with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.

Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program, required by the Food and Drug Administration, called the Lazanda REMS (Risk Evaluation and Mitigation Strategy) program. Under the Lazanda REMS program,healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program to prescribe, receive, dispense, and distribute Lazanda, respectively. [see Warnings and Precautions]. Further information is available at http://www.LazandaREMS.com or by calling 1-855-841-4234.

Contraindications

  • Lazanda is contraindicated in the management of pain in opioid non-tolerant patients, because life-threatening hypoventilation could occur at any dose in patients not already taking around-the-clock opioid therapy.
  • Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
  • Lazanda is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.

Warnings And Precautions

  • Patients must not be converted to Lazanda from other fentanyl products because it is not equivalent to other fentanyl products on a mcg per mcg basis, and such substitution could result in a fatal overdose; do not substitute Lazanda for another fentanyl product when being dispensed.
  • Serious or fatal respiratory depression can occur even at recommended doses in patients using Lazanda. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.
  • Lazanda could be fatal to individuals for whom it is not prescribed and for those who are not opioid tolerant.
  • Patients and their caregivers must be instructed that Lazanda contains medicine in an amount that could be fatal to a child and thus must keep both used and unused bottles in their child-resistant container and out of the reach of children at all times and all residual fentanyl must be emptied before disposal.
  • Patients on concomitant CNS depressants must be monitored for a change in opioid effects and adjust the dose of Lazanda.
  • Concomitant use with potent cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Monitor and consider dosage adjustment if warranted.
  • Cautiously adjust the dose of Lazanda in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression.
  • Administer Lazanda with extreme caution in patients particularly susceptible to intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
  • Patients taking Lazanda must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
  • Use Lazanda with caution in patients with bradyarrhythmias.
  • Lazanda is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Drug Interactions

  • Potential interactions may occur when Lazanda is given concurrently with agents that affect CYP3A4 activity. Monitor patients for signs of opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP3A4 or stop therapy with, or decrease the dose of, inducers of CYP3A4.Monitor patients who are taking vasoconstrictive nasal agents to treat allergic rhinitis for potentially impaired pain management.

Use In Specific Populations

  • Safety and efficacy below 18 years of age have not been established.
  • There are no adequate and well-controlled studies of Lazanda in pregnant women. Do not use Lazanda during labor and delivery or in women who are nursing.
  • Lazanda should be administered with caution in patients with impaired renal or hepatic function and titrated to clinical effect in patients with severe renal or hepatic disease.

Adverse Reactions

  • Most common adverse events during titration (frequency greater than or equal to 5%): nausea, vomiting, and dizziness.
  • Most common adverse events during maintenance (frequency greater than or equal to 5%): vomiting, nausea, pyrexia, and constipation.

Please see the accompanying full Prescribing Information including boxed warning. For more information please see http://www.lazanda.com.

About Archimedes Pharma

Archimedes Pharma is an international specialty pharmaceutical company providing novel and advanced treatments to address unmet needs for people living with serious or life-threatening chronic and debilitating illnesses. Archimedes Pharma markets a diverse portfolio of speciality products and has operations in the U.S. and throughout Europe. Archimedes Pharma U.S. Inc. is a subsidiary of Archimedes Pharma Ltd. For more information, please visit: http://www.ArchimedesPharma.com.

Lazanda®, PecFent®, and PecSys® are registered trademarks of Archimedes Development Ltd.

SOURCE Archimedes Pharma Ltd.

Posted: June 2011

Posted in Health & Wellness Information | Tagged: , , , , , , , | 1 Comment »

WebMD – FDA Warning – FDA: Repairing Pelvic Organ Prolapse With Mesh Risky

Posted by 4love2love on July 18, 2011

Risks Include Pain, Infection, Need for Additional Surgery
By Denise Mann
WebMD Health News
Reviewed by Laura J. Martin, MD

Surgical clamps in tray

July 13, 2011 — The risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, according to the FDA.

Risks include mesh protruding out of the vaginal tissue (erosion),pain, infection, bleeding, pain during sexual intercourse, organ perforation from tools used in the mesh placement, and urinary problems.  Additional surgeries and/or hospitalization may be needed to treat the complications or remove the mesh.

During pelvic organ prolapse, the internal structures that support the pelvic organs such as the bladder, uterus, and bowel drop from their normal position and “prolapse” into the vagina. Pelvic organ prolapse surgery can also be performed through the abdomen or vagina with stitches or surgical mesh to reinforce the repair and correct the anatomy. Surgical mesh is also widely used in hernia repairs and to treat stress incontinence.

In 2010, there were at least 100,000 pelvic organ prolapse repairs that used surgical mesh, and about 75,000 of these were transvaginal. These are the only procedures that the new FDA mesh warning applies to.

The FDA first issued a safety communication in 2008 after they received reports of adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has increased, although they don’t always differentiate between transvaginal and abdominal procedures. The group also reviewed the literature on the use of mesh for this procedure.

Now, the FDA will convene an outside panel of experts in obstetrics and gynecology to meet in September 2011 and discuss the safety and effectiveness of surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence.

FDA: Risks Outweigh Benefits

“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” says William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks.”

“Mesh is a permanent implant, and complete removal may not be possible and may not result in complete resolution of complications,” he says.

“This is not an indictment of surgical mesh,” he says. “We are talking about a very specific use of surgical mesh.”

There may still be a role for mesh in certain transvaginal pelvic organ prolapse procedures, he says.

“Some clinicians believe that the use of mesh for transvaginal pelvic organ prolapse is appropriate and is the best treatment option for selective patients such as those with severe pelvic organ prolapse,” he says.

Women who have had surgery for pelvic organ prolapse need to understand whether or not their procedure involved mesh. “For someone considering having a procedure for pelvic organ prolapse, speak with a doctor and understand if the surgery is going to use mesh, and ask about the benefits and why the decision was made,” he says.

Many Support FDA Action

Elizabeth A. Poynor, MD, a pelvic surgeon at Lenox Hill Hospital in New York City, has never used mesh for transvaginal pelvic organ prolapse and likely never will.

“I don’t use mesh in my practice because I have seen a significant number of complications from other surgeons, and have seen how mesh erosion can be devastating for patients,” she says.

As to why use of mesh implants for this surgery took off in the first place, she says it may have a lot to do with the complexity of the procedure.

“This is one of the most detailed and complicated surgeries that we do and unless it is done correctly, it can have a significant chance of failing,” she says. Some surgeons believe the mesh boosts the chances of a successful surgery.

“There has been the general feeling that repairs are better and sounder if mesh is used, but mesh may not be better than the proper surgical correction,” she says.

“Women who are considering prolapse surgery should review the risks, benefits, and alternatives with their surgeon to make sure that it is the right choice,” Poynor says.

“This has been a long time coming,” says J. Eric Jelovsek, MD, a staff physician in the Obstetrics, Gynecology, & Women’s Health Institute of the Cleveland Clinic in Ohio.

Mesh placed transvaginally for pelvic organ prolapse does have some anatomical benefit, but that is it, he says. “Quality of life is no different if mesh is placed or not, and women have a higher risk of complications,” he says.

“This doesn’t mean that you should never have mesh placed transvaginally. It means you have to have an in-depth discussion with your surgeon of the options,” he says.

For women who have had the procedure with mesh, “if you are feeling fine and doing well, there is no reason to come in and get this checked out, but if you have question or concerns, then come in,” he says.

Most of the complications will occur in the year or two after the surgery, but others such as vaginal bleeding, pain with sex, and severe pelvic pain may develop later on.

Robert F. Porges, MD, MPH, director of the division of pelvic reconstructive surgery and urogynecology and a professor of obstetrics and gynecology at New York University Langone Medical Center in New York City, seldomly uses mesh during transvaginal pelvic organ prolapse repair.

But, he says, “in some severe cases where the muscles of the pelvic floor have been severely damaged or failed to develop, replacing the muscle with mesh may play a role,” he says. “Most women deserve an attempt to repair the prolapse using their native tissues and unless it is a failure or a repeat failure, using the mesh may not be as valuable as made out to be,” he says.

In a written statement, the American College of Obstetricians and Gynecologists applauded the FDA’s efforts. “The College supports FDA’s upcoming initiative to convene an advisory committee, the Obstetrics Gynecology Devices Panel, to discuss the safety and effectiveness of [mesh] and notes with appreciation FDA’s willingness to reconsider how it clears mesh products for marketing.”

© 2011 WebMD, LLC. All rights reserved.

Posted in Health & Wellness Information, News Articles | Tagged: , , , , , , , | 1 Comment »

WebMD – Cosmetic Surgery Self-Assessment

Posted by 4love2love on July 18, 2011

Most people seek cosmetic surgery to feel better about themselves. Does it work? Studies suggest that patients are generally pleased with the outcome of their cosmetic surgery and report improvement in self-esteem, social confidence, and quality of life.

However, cosmetic surgery may not be appropriate for every person or every problem. If you are considering cosmetic surgery, take some time to contemplate these questions:

1. Why am I considering cosmetic surgery?

The healthiest reason to have cosmetic surgery is to improve your self-image — the way that you feel about yourself. People who have a strong self-image are usually more confident, effective in work and social situations, and comfortable with their relationships. Cosmetic surgery is often thought of as psychological surgery. Its purpose is to enhance your feeling of well-being and to foster emotional health.

2. Am I having cosmetic surgery to please others or myself?

Make sure that you are considering cosmetic surgery for internal reasons having to do with yourself, and not external reasons. Cosmetic surgery cannot stop your boyfriend from leaving you. It cannot bring you new friends. It cannot get you a better job. You’ll likely be disappointed in the results if you are having cosmetic surgery to please someone else.

3. Are my expectations realistic?

Having realistic expectations may be the single most important factor in achieving a successful result. Cosmetic surgery can dramatically improve your appearance, but it has its limitations. It is unwise to expect that cosmetic surgery can create the face of a celebrity (with the hope of acquiring a celebrity lifestyle) or restore the lost youth of decades past.

4. Am I emotionally prepared for cosmetic surgery?

There are certain circumstances under which cosmetic surgery may be inappropriate. These include a crisis or an emotional upheaval such as divorce, death of a spouse, or loss of a job. Also, surgeons are reluctant to consider cosmetic surgery on patients who are depressed, have significant mental illness, are impossible to please, or are obsessed with perfection.

5. Is now the best time for cosmetic surgery?

Even if you are emotionally prepared for cosmetic surgery, you may want to delay it if you are under external pressure or preoccupied with other matters. Plan your surgery when you are relaxed and can afford the time to convalesce and heal afterwards. Otherwise, you may face longer and more difficult recovery periods.

6. How will I adjust to the change in my body image?

It may take some time for you to adjust to your new body image. This is especially true for procedures that create a major change to your face, such as nose surgery (rhinoplasty). Procedures such as Botox injections, which merely create a younger looking you, are easier to accept.

7. Am I prepared to handle unexpected results?

Cosmetic surgeons, like all surgeons, cannot offer you guaranteed results. Unexpected results occur rarely, but when they do occur they create emotional distress for both the patient and the surgeon. You must be prepared for the worst case scenario and realize that it will require time, patience, and a mutual trust between you and your surgeon to work toward improvement.

8. Do I have a support network?

It’s important to have someone to support you physically and emotionally during your recovery. Realize that you may have days when you feel depressed as you go through the healing period. Beware of negative comments from friends or family members who may have issues with your decision to change your appearance. Graciously decline offers of help from those who may be critical of your decision.

9. Have I considered and accepted the risks?

There is risk involved with any surgery. In addition to the general risks related to anesthesia, blood loss, and infection, specific risks for cosmetic surgery include skin loss, asymmetry, slow healing, numbness and minor dimples and puckers. You must consider and accept all of the risks for each procedure before making your decision to have cosmetic surgery.

10. Can I afford cosmetic surgery?

Cosmetic surgery is usually not covered by health insurance. You are choosing to accept the costs in exchange for surgery that will help you feel better about yourself. If you can’t afford the cost, in addition to a second procedure should one be needed, the added financial stress could actually make you feel worse about yourself.

 

© 2009 WebMD, LLC. All rights reserved.

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