Medical Study Links Fosamax to Femur Bone Fracture

A medical study in the Journal of Orthopedic Trauma links Fosamax to a rare type of fracture in the femur. The small, observational study looked at 70 patients who experienced low-energy femur fractures, which occur when someone falls from a standing height or less. Twenty-five patients (36%) were taking Fosamax on average for four years or more. The Fosamax patients’ fractures had some distinct characteristics: nineteen (76%) of the 25 patients had a simple fracture with a straight line across the bone and a beak-like overhang on one side. Also, the patients’ bones didn’t look like typical osteoporotic bone; they looked strong.

Merck Disagrees with Fosamax Fracture Femur Medical Study

Merck pointed out that Fosamax and other bisphosphonate medications have been shown to decrease the risk of a type of femur fractures common in patients with osteoporosis. In a statement on the new study, Merck said that “a causal association with bisphosphonates and either the fracture pattern or the frequency of these fractures has not been established by the authors.”

Speak to a Fosamax Lawyer

If you took Fosamax and suffered osteonecrosis of the jaw (ONJ), a broken leg, or femur fracture, we encourage you to contact a Fosamax attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Fosamax. Contact our law firm and learn more about your legal rights and the options available to you and your family.

Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:

• DonJoy Cold Therapy Machines
• PolarCare Cold Therapy Machines
• EBIce Cold Therapy Machines

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

Cold Therapy Attorney

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.

Cold Therapy Side Effects

Cold therapy side effects may include one or more of the following:

• Skin damage
• Nerve damage
• Wrist, ankle, shoulder or back injury
• Hand amputation
• Foot amputation
• Loss of a limb
• Arm amputation
• Leg amputation
• Complex Regional Pain Syndrome (CRPS)
• CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury)
• CRPS 2 (caused by an injury to the nerve)
• Reflex Sympathetic Dystrophy (RSD)
• Reflex Sympathetic Dystrophy Syndrome (RSDS)
• Complex Regional Pain Syndrome
• Shoulder-Hand Syndrome
• Causalgia
• Sudeck’s Atrophy

Cold Therapy Machines Under Investigation

Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:

• DonJoy Cold Therapy Machines
• PolarCare Cold Therapy Machines
• EBIce Cold Therapy Machines

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

For more information regarding cold therpy lawsuits, please fill out our form on the right side of this page or give our law firm a call at our toll free number (located in the top right corner).

Cold Therapy Attorney

Poorly designed cold therapy machines may cause permanent skin damage (frost bite), nerve damage, and numerious other serious side effects. Seek immidiate medical attention if you are suffering an emergency situation.

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.

Depakote Side Effects

Severe Depakote side effects may include:

• Malformations
• Intrauterine growth retardation
• Neural tube closure defects
• Coarctation of the aorta
• Atrial septal defects
• Pulmonary stenosis
• Hypoplastic right heart
• Dysplastic ribs
• Cleft palate
• Hand malformations
• Hydronephrosis (distention and dilation of the renal pelvis)
• Undescended testes
• Hypospadias (male birth defect that involves the urethral opening occurring in the wrong place)
• Skeletal defects
• Spina bifida
• Spina bifida occulta
• Spina bifida closed neural tube defects
• Spina bifida meningocele
• Spina bifida myelomeningocele (cystica)
• Anencephaly
• Rachischisis
• Death of the newborn

Speak to a Depakote Lawyer

If your child was born with severe birth defects that may have resulted from taking Depakote during pregnancy, contact our law firm immediately to discuss your legal options. Speak to a lawyer about your child’s skeletal defects, spina bifida, growth retardation or other injuries and learn about what legal options are available to your family. Our law firm has represented thousands of clients over the last twenty five years and thoroughly understands drug litigation. Contact an attorney today for a free and confidential Depakote lawsuit evaluation.

Byetta Information

Byetta is made by Amylin Pharmaceuticals Inc, and marketed jointly by Amylin and Eli Lilly & Co. The drug was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. While Byetta may lower blood glucose levels on its own, it can also be combined with other medications such as pioglitazone, metformin, sulfonylureas, and/or insulin (not FDA approved yet) to improve glucose control. The approved use of exenatide is with either sulfonylureas, metformin and thiazolinediones. Byetta is injected subcutaneously twice per day using a pre-filled pen device.

Byetta Lawyer

If you or a loved one were prescribed Byetta and have been diagnosed with serious side effects including acute pancreatitis, necrotizing pancreatitis or hemorrhagic pancreatitis, then you may have a legal right to file a Byetta pancreatitis lawsuit. Please contact our law firm to discuss your legal options. Your initial consultation with a Byetta lawyer about your potential case is free and confidential.

Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

• NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
• NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.

Unomedical notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.

Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF- 2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: www.fda.gov/medwatch.

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP’s public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The webpage is: www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at: www.fda.gov/medwatch.