Source | FDA

Agency Working with Product Manufacturers

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments.

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of a nationwide Class I recall of
RF Denervation probes used with the Smith & Nephew Electrothermal 20S
Spine System in RF heat lesion procedures for the relief of pain. The
product was mislabeled. The device is a non-sterile (not germ free)
device but it was labeled incorrectly as sterile (germ-free). It is a
reusable item that is intended to be sterilized (made germ-free) by the
medical facility prior to each use, including initial use. This error
may result in infections with associated risks including, organ failure
and/or death.

Read the complete MedWatch 2007 Safety summary, including a link to the
FDA recall notice and firm press release, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes

Source | FDA

FOR IMMEDIATE RELEASE — Andover, MA — March 26, 2007 — Smith & Nephew Inc. is initiating a nationwide recall of 539 RF Denervation probes for the part numbers and models listed in the table below.

The Smith & Nephew RF Denervation probes are indicated for use exclusively with the Smith & Nephew ELECTROTHERMAL(TM) 20S SPINE SYSTEM in RF heat lesion procedures for the relief of pain. The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.

Customers who have product that is being recalled should return it to Smith & Nephew per the recall instructions. The recall includes the following products and lot numbers:

Part #

Description

Lot numbers

7210270

RF Denervation Probe

602549, 602550, 602846, 602847

7210271

RF Denervation Probe

602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999

7210272

RF Denervation Probe

602543, 602570, 602571, 602850, 603000

The company voluntarily recalled the products after learning of the labeling error. FDA has been apprised of this action. No injuries have been reported to date associated with this issue.

Product was distributed to 134 domestic and international customers. It can be identified by the product number, name, and lot numbers identified above. Smith & Nephew has notified its distributors and customers and is arranging for return and replacement of all recalled products.

Denervation Probe Investigation

If you or a loved one have used the Smith & Nephew probe and received a serious infection; we would like to speak with you. Please contact us by using the form at the bottom of this page or by dialing (866) 588-0600.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of new emerging safety concerns
about Zyvox (linezolid) from a recent clinical study. This open-label,
randomized trial compared linezolid to vancomycin, oxacillin, or
dicloxacillin in the treatment of seriously ill patients with
intravascular catheter-related bloodstream infections including those
with catheter-site infections. Patients treated with linezolid had a
higher chance of death than did patients treated with any comparator
antibiotic, and the chance of death was related to the type of organism
causing the infection. Patients with Gram positive infections had no
difference in mortality according to their antibiotic treatment. In
contrast, mortality was higher in patients treated with linezolid who
were infected with Gram negative organisms alone, with both Gram
positive and Gram negative organisms, or who had no infection when they
entered the study.

Linezolid is not approved for the treatment of catheter-related
bloodstream infections, catheter-site infections, or for the treatment
of infections caused by Gram negative bacteria. If infection with Gram
negative bacteria is known or suspected, appropriate therapy should be
started immediately.

Source | FDA

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion

*This recall notice was updated on January 24, 2007, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued (see all recall announcements). The expanded list below includes all recalled product codes and lot numbers.*

Extra Large Oval, 8.7” x 10.7”
All Lot Numbers manufactured before January 2006
Product Code: 0010206 

Extra Large Oval, 10.8” x 13.7”
All Lot Numbers manufactured before January 2006
Product Code: 0010206

Extra Large Oval, 7.7” x 9.7”
All Lot Numbers manufactured before January 2006
Product Code: 0010206

Oval, 6.3” x 12.3”
All Lot Numbers manufactured before January 2006
Product Code: 0010206

Large Oval, 5.4” x 7.0”
All Lot Numbers manufactured before January 2006
Product Code: 0010206

Large Circle, 4.5”
All Lot Numbers manufactured before January 2006
Product Code: 0010206

Use:

The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Reason for the Recall:

The “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

FDA Comments:

• On January 10, 2007, Davol, Inc. (a subsidiary of C.R. Bard) sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.
   
• Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
   
• It should be noted that product codes 0010202 and 0010204 were involved in both recall expansions. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March expansion, Davol received 4 confirmed complaints of recoil ring breakage from product code 0010202 manufactured between January 2004 and September 2005. There were no complaints for product code 0010204 . Davol is recalling the following lotsfor product codes 0010202 and 0010204:
  • All lots with the letter “O” in the fourth position
  • All lots with the letter “P” in the fourth position and the letters “A” through “I” in the third position.

  For instance, an example of a recalled lot number is “43IPD###.”

  • Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm’s removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA. Davol is withdrawing the following lots:
  • All lots with the letter “P” in the fourth position and the letters “J” through “L” in the third position
  • All lots with the letter “Q” in the fourth position and the letters “A” through “I” in the third position

  For instance, an example of a withdrawn lot number is “43IQD###.”

  • An upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity.” If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.
  • Davol notified U.S. customers of the initial recall by letter on 12/27/05 via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information. Copies of current product IFUs to be used for both Open Placement and Laparoscopic Placement for the Large Bard® Composix® Kugel® Mesh Patches are available from Davol Customer Service by calling 1-800-531-4124.

  Do I Have a Kugel Mesh Patch Lawsuit?

  If you or a loved one has suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel Mesh Patch, you should contact us immediately. You may be entitled to compensation and we can help.

  Kugel Mesh Patch Lawsuit

   

Source | FDA

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch

*This recall notice was updated on March 31, 2006, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued (see previous announcement) . The expanded list below includes all recalled product codes and lot numbers.*

Use:

The Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Reason for the Recall:

The “memory recoil ring” that opens the Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Do I Have a Kugel Mesh Patch Lawsuit?

If you or a loved one has suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel Mesh Patch, you should contact us immediately. You may be entitled to compensation and we can help.

Kugel Mesh Patch Lawsuit

Source | FDA 

Class 1 Recall: Bard® Composix® Kugel® Mesh X-Large Patch

Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:

• 41XMXXXX – M = 2002
• 41XNXXXX – N = 2003
• 43XMXXXX – M = 2002
• 43XNXXXX – N = 2003
• 43XOXXXX – O = 2004
• 43XPXXXX – P = 2005

(If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.)

Use:

The Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Reason for the Recall:

The “memory recoil ring” that opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Do I Have a Kugel Mesh Patch Lawsuit?

If you or a loved one has suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel Mesh Patch, you should contact us immediately. You may be entitled to compensation and we can help.

Kugel Mesh Patch Lawsuit

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

For more information on the sedative hypnotic products and sleep disorders, visit http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.

####

The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the naturally occurring human protein, erythropoietin. Natural erythropoietin is made by the kidney and increases the number of red blood cells).

FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.

Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.

“The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies,” said Steven Galson, MD, MPH, director of FDA’s Center for Drug Evaluation and Research. “The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”

Safety concerns from earlier ESA studies were discussed during a 2004 meeting of the ODAC. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia – including fatigue – in cancer patients, surgical patients, or those with HIV.

All three drugs are manufactured by Amgen Inc. of Thousand Oaks, California. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of new safety information for
erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa),
Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in
patients with cancer found a higher chance of serious and
life-threatening side effects or death with the use of ESAs. These
research studies were evaluating an unapproved dosing regimen, a patient
population for which ESAs are not approved, or a new unapproved ESA. FDA
believes these new concerns apply to all ESAs and is re-evaluating how
to safely use this product class. FDA and Amgen, the manufacturer of
Aranesp, Epogen and Procrit, have changed the full prescribing
information for these drugs to include a new boxed warning, updated
warnings, and a change to the dosage and administration sections for all
ESAs.