Dallas Personal Injury Lawyer - Defective Drugs

Actavis Recalling Remaining Lots of Fentanol Pain Patches

RLF Staff — Mon, 03 Mar 2008 15:38:28 GMT

Actavis Inc has recalled all remaining lots of Fentanyl Pain Patches. As with the previous recalls, there may be a defect that could cause fentanyl to leak directly to the skin of the patient or caregiver and cause an Fentanyl overdose. Fentanyl overdose could cause difficulty breating or even death. Actavis recalled 14 lots of the Fentanyl Pain Patches a few weeks ago and now are recalling all remaining lots of their fentanyl transdermal system patches. They say this additional recall is as a precautionary measure.

Fentanyl patches that are leaking or damaged in any way should not be used. Direct exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

Originally posted at InjuryBoard by RLF Staff

More Fentanyl Pain Patches Recalled

RLF Staff — Wed, 20 Feb 2008 09:31:17 GMT

Another Fentanyl pain patch has been recalled today due to the risk of accidental Fentanyl overdose. Activis Inc. has recalled 14 lots of its Fentanyl transdermal system CII patches as a cautionary measure. Fentanyl transdermal patches (sold as Duragesic) are prescribed to treat severe chronic pain that requires constant medication for extended periods.

This is the second fentanyl pain patch recall this month. The first recall was due to defective Duragesic patches. The Duragesic patches had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking and cause a Fentanyl overdose.

According to the FDA, the Fentanyl transdermal patches being recalled may have a defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl directly can cause breathing problems and overdose, which can be fatal.

The fentanyl patch included in ths recall are:
27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09)

The fentanyl pain patches have an Abrika Pharmaceuticals label, and the outer carton has the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-08.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-08.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-08.

Originally posted at InjuryBoard by RLF Staff

Adverse Reactions Spur Recall of Baxter Heparin Vials

RLF Staff — Tue, 29 Jan 2008 15:39:59 GMT

Heparin Sodium Injection Vials were recalled due to an increase in adverse Heparin reactions. Baxter has received 100 reports of reactions and is looking into one death that may be linked to the Baxter Heparin recall.

A variety of Heparin-caused reactions have been reported such as burning sensation, chest pain, abdominal pain, lowered blood pressure, diarrhea, dizziness, flushing, headache, hypotension, loss of consciousness, nausea, restlessness, vomiting, and stomach discomfort among others.

Nine lots of Heparin Sodium 1000 unit/mL for injection are included in the recall:

NDC# 0641244045, Lot #107054, Heparin 1000units/mL 10mL vial, expiration date 10/2009
NDC# 0641244045, Lot #117085, Heparin 1000units/mL 10mL vial, expiration date 11/2009
NDC# 0641245045, Lot #047056, Heparin 1000units/mL 30mL vial, expiration date 10/2008
NDC# 0641245045, Lot #097081, Heparin 1000units/mL 30mL vial, expiration date 09/2009
NDC# 0641245045, Lot #107024, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107064, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107066, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107074, Heparin 1000units/mL 30mL vial, expiration date 10/2009
NDC# 0641245045, Lot #107111, Heparin 1000units/mL 30mL vial, expiration date 10/2009

The Baxter recall notice states no deaths have been connected to the recalled Heparin vials, however, a Florida TV station reported that one patient had died, and four others had suffered reactions that could be linked to the recalled products. State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility to discover if the patient's death and the other reactions were linked to the recalled Heparin.

Originally posted at InjuryBoard by RLF Staff

Aranesp , Epogen, and Procrit Linked to Increased Tumor Growth

RLF Staff — Fri, 04 Jan 2008 06:58:20 GMT

The FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study, and the National Cancer Institute Gynecologic Oncology Group, showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an Erythropoiesis-Stimulating Agent (ESA). Both the PREPARE study in breast cancer and the COG-19 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA. FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival in patients with cancer before starting or continuing ESA therapy.

On November 8th, the FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and other serious conditions. The new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

Additionally, the new boxed warnings clarify that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Further, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

for more information: http://www.fda.gov/cder/drug/early_comm/ESA.htm

Please see our section on FDA Prescription Drugs.

Originally posted at InjuryBoard by RLF Staff

Adderall, Ritalin, ADHD Drugs Linked to Heart Issues

RLF Staff — Wed, 12 Dec 2007 08:13:55 GMT

Adderall, Ritalin and other ADHD treatments have been linked to hundreds of yearly ER visits with heart related symptoms, a new study says. This latest study of ADHD drugs was the first to look at potential heart problems linked to the medications since the Food & Drug Administration (FDA) updated their labels last year to include heart warnings.

ADHD stimulants such as Adderall and Ritalin cause a rise in blood pressure which prompted the FDA to add a warning of cardiovascular risk to many ADHD prescriptio ndrugs. The new warning included sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by RLF Staff

More Reports of Chantix Negative Effects

RLF Staff — Thu, 29 Nov 2007 15:27:35 GMT

The Food and Drug Administration announced last they are finally looking into Chantix, a stop smoking medication, to find out how dangerous it might be.

Since the report of Carter Albrecht's unusual behavior and death while taking Chantix, hundreds of other Chantix patients have spoken up about the effects they've experienced. Over the last two months, Ryann Rathbone said she has received countless e-mails from people thanking her for bringing attention to the possible side effects of Chantix.

The FDA recieved ofer 5,000 complaints from Chantix patients including over 200 reports of suicide or suicidal thoughts, about 500 cases of depression and many others complained of unusual anger, aggression, amnesia, hallucination and homicidal thoughts as early as two days after starting Chantix to help quit smoking.

The FDA said they are looking into 100 specific psychotic incidents in the United States.

Even before Albrecht's death, the FDA said they had planned an investigation based on complaints in Europe where Pfizer sold the drug as Champix since 2006.

The FDA is urging doctors to carefully monitor patients on the drug. People should also report side effects to the FDA.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by RLF Staff

Chantix Linked to Depression, Suicidal Thoughts and Aggressive Behavior

RLF Staff — Wed, 21 Nov 2007 06:30:44 GMT

The US Food and Drug Administraion is reviewing reports of suicidal thoughts and aggressive behavior in people who have taken Chantix, a prescription medication used to quit smoking.

Chantix works on specific areas of the brain, helps people give up smoking by providing some satisfaction that nicotine gives intended to lessen withdrawal symptoms. It also blocks the nicotine from entering the parts of the brain that cause the craving for nicotine which prevents the normal 'pleasure' from smoking.

Chantix has been through several clinical studies which resulted in more than twice the smokers quit smoking compared to Zyban, another quit-smoking drug. Smokers need to be ware though as Chantix has many side effects ranging from 'changes in dreaming' which many have described as "vivid dreams" to suicidal thoughts and aggressive behavior. According to reports from Chantix patients, these side effects seem to increase drastically when Chantix is taken with alcohol although no official studies have been completed to confirm this.

Extreme drowsiness has also been a side effect which can affect patients' ability to drive. A preliminary study shows many cases reflect an onset of depressed mood, suicidal ideation, and changes in emotion and behavior starting sometimes within few days after first taking Chantix.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by RLF Staff

Accutane Linked to Lower Serotonin Levels and Depression

RLF Staff — Mon, 19 Nov 2007 08:21:50 GMT

Accutane is prescribed to treat acne, but has been linked to depression and other psychiatric issues including over 250 suicides in the US. Accutane may cause decreased serotonin levels, which can lead to depression and aggressiveness.

In the late '80s, Accutane went under fire due to the risk of birth defects, kidney, digestive tract, central nervous system, pancreas, cardiovascular, liver, and auto-immune system problems among others.

A study of the cellular effects of Accutane showed the relays between neurons in the brain (which are produced from serotonin) were disrupted.

Serotonin is a hormone found in the brain and other areas of the body and acts as a messenger, transmitting signals between nerve cells. Decrease in the serotonin levels in the brain have been linked to depression, bipolar disorder and anxiety disorders.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by RLF Staff

Viagra, Levitra, Cialis, Revatio Patients Warned of Risk of Hearing Loss

RLF Staff — Thu, 18 Oct 2007 15:30:39 GMT

The Food and Drug Administration (FDA) informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension.

In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The precaution and updated Adverse Reactions Sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.

Read the complete FDA MedWatch Summary and Drug Information Page for Viagra, Levitra, and Cialis regarding this issue at http://www.fda.gov/medwatch/safety/2007/safety07.htm#PDE5

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by RLF Staff

Microwave Popcorn Could Cause Serious Lung Disease

RLF Staff — Tue, 11 Sep 2007 12:12:29 GMT

Major popcorn manufacturers who use Diacetyl in their popcorn have started removing the "buttery smalling" chemical from their products. This comes more than a year (and consumption of more than 750 million pounds of popcorn) after the EPA produced a study warning Diacetyl poses potential health hazards. Diacetyl was identified at the CDC in 2002 as the cause of a debilitating and sometimes fatal lung disease among workers in the plants where it is produced.

Bronchiolitis Obliterans or "popcorn lung" is the disease caused by Diacetyl which is used to make popcorn smell "buttery."

Since Arpil 2006 when the EPA completed their study of the air released from bags of microwave popcorn, there has been at least one report of "significant lung disease whose clinical findings are similar to those described in affected workers."

If you believe you may have been adversely affected by Diacetyl, contact a product liability attorney as you may be entitled to compensation for medical bills, lost wages and pain and suffering.

For more information on this subject matter, please refer to the section on Drugs, Medical devices, and Implants.

Originally posted at InjuryBoard by RLF Staff