Orlando Personal Injury Lawyer - Drug Products

FDA Issues Warning on Use of Tussionex

Sandy Grinnell — Wed, 12 Mar 2008 05:11:32 GMT

Tussionex Pennkinetic Extended-Release Suspension is an often prescribed childrens cough suppressant that contains hydrocodone and the extened release antihistamine chlorpheniramine. The Food and Drug Administration has issued this warning because the medication is improperly being used on patients younger than 6 years old, and is being prescribed and administered more frequently than the allowed dosage.

Administering the dosage more frequently than approved, prescibing to children under the age of 6 or improper measuring of the medicine can lead to death or life-threatening breathing problems. The FDA has issued the following recommendations:

Do not give to children less than 6 years old. FDA has received reports of death due to respiratory depression with use of Tussionex in patients less than 6 years old.

Healthcare professionals should not prescribe and patients should not take Tussionex more often than every 12 hours. Taking this cough medicine more often than every 12 hours may result in a narcotic overdose. Too much hydrocodone can cause life-threatening breathing problems and death. If the cough is not controlled when taking Tussionex every 12 hours, talk to your doctor before taking more.

Healthcare professionals who prescribe and patients who use Tussionex should be aware of the signs of hydrocodone overdose including the following: trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients, parents, or caregivers should get medical attention right away.

Patients and parents should use a device designed to accurately measure Tussionex. Household teaspoons or tablespoons vary in size and can result in giving too much of the medicine. Use a syringe or spoon specifically designed to measure liquid medicine.

The FDA also indicated that overdoses with life-threatening breathing conditions have been seen in children older than 6, adolescents and young adults. The dosage and frequency should be followed exactly as prescribed to avoid any of these danderous side effects.

Originally posted at InjuryBoard by Sandy Grinnell

Heparin Recalled by Baxter Healthcare

Ed Normand — Fri, 07 Mar 2008 18:24:39 GMT

Heparin sodium is medication used to thin the blood. It is often administered intravenously. It is used with patients that need kidney dialysis, many types of cardiac surgery, and many other conditions often those involving risk of blood clots. Severe injuries have been reported with this drug recently. The adverse events usually started within minutes of the administration of the heparin initiation but there may also be a delayed reaction. In the short time since December 2007 there has been about 350 known problems with this drug according to the FDA. Other reports indicate there may have been as many as 800 adverse reactions from the drug. Sadly as many as forty percent of the incidents are considered to be serious with 46 patients that may have died from the drug.

The heparin products at issue were all distributed by Baxter Healthcare Corporation. The recall began on January 17, 2008.

According to the United States Food and Drug Administration, the FDA, the cause of this huge number of adverse events from the heparin from this distributor is not yet known to the FDA. A recent article in the NY Times suggests that Baxter Healthcare and its supplier Scientific Protein Laboratories are providing conflicting stories about who is at fault and why. We will keep you informed.

Originally posted at InjuryBoard by Ed Normand

FDA Warning - Internet Sales of Bogus STD Preventatives

Sandy Grinnell — Thu, 06 Mar 2008 17:28:19 GMT

The FDA issued an emergency alert today warning consumers of drugs being sold on the Internet falsely claiming that they can prevent or treat sexually transmitted diseases. The products are sold under the names of Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus and make claims such as:

"Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).

Since these drugs have not been submitted to the FDA, they are in violation of FDA rules and should not be taken as they have not been tested for the safety or effectiveness and may pose a health threat to consumers. The FDA regards these drugs as "mislabeled" and/or "misleading" and states they do not include sufficient instructions for consumers.

Consumers should stop taking these drugs immediately and should report any adverse effects to the FDA's MedWatch group at 800-FDA-1088.

Originally posted at InjuryBoard by Sandy Grinnell

FDA Early Communication Regarding Botox and Botox Cosmetic

Sandy Grinnell — Sat, 09 Feb 2008 07:14:09 GMT

The FDA reported today it is performing a "safety review" of Botox and Botox Cosmetic. The review is a result of adverse reactions reported when both A and B types of botulinum toxins were used for injections approved by the FDA and one that has not been approved by the FDA.

The FDA has approved Botox to treat spasms in the neck or eyelids and to reduce excess sweating; Botox Cosmetic to treat fine lines or wrinkles. Apparently there is information out in the medical community that the bolulinum toxins can also be used to treat severe muslce spasms in children and adults, primarily in cerebral palsy patients.

The FDA has not approved the toxins for any child under the age of 12 and has received adverse reaction reports of the toxin being used on children 16 and under. The adverse reactions range from a difficulty in swallowing or breathing which required breathing tubes or being placed on a ventilator to even death of the patient. There were similar adverse reports in adults; some were hospitalized, but there were no deaths reported.

Since the FDA has not finished its review of the adverse reaction reports, manufacturer safety data, medical literature and clinical studies, the FDA is not advising physicians to suspend use of the botulinum toxins. However, there are recommendations that should be followed:

Understand that potency determinations expressed in "Units" or "U" are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
Understand that these effects have been reported as early as one day and as late as several weeks after treatment
Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

There will be more communications on this subject as the FDA progresses with its studies.

Originally posted at InjuryBoard by Sandy Grinnell

Little Recourse for Patients Injured in Drug Trials

Mike Damaso — Wed, 06 Feb 2008 05:08:19 GMT

There was an interesting article in the Wall Street Journal this weekend regarding the problem of patients injured by new drugs during clinical trials having little to no recourse. The article blames the problem on several factors including: 1. Confusing and vague consent forms; 2. Lack of clarity as to which research entity is responsible for subsequent care; 3. Uncertainty as to how much that entity will pay and under what circumstances it is obligated to pay; and 4. Difficulty in trying to separate what was directly caused by the trial from the natural progression of the participant's disease. The article also blames the lack of legal, regulatory, and governmental oversight. It reports that Federal Law does not require researchers to compensate participants injured in clinical trials. It only requires that the consent forms set out whether compensation exists for research related injuries in trials that involve more than a "minimal risk."

The article notes two case specific examples. In one, an 18 year old died when involved in a gene-therapy trial at the University of Pennsylvania. The attorney who represented the family of the boy was able to obtain a settlement in the case for an undisclosed amount. That attorney is quoted in the article as saying many lawyers are reluctant to get involved in clinical trial injury cases because they worry that the consent forms protect drug companies and research institutions from liability. But, the attorney from the Penn case shows that it is possible to find flaws in the informed consent process and has handled 13 clinical trial cases since, with 11 partial or full settlments.

The other case noted in the article involved a 71 year old retired kindagarten teacher who suffered from Parkinson's and was talked into a clinical trial by a treating neulologist at UCLA. The trial involved surgically implanting an experimental drug called Spheramine into her brain. Prior to the surgery, she could drive, cook, and care for herself. Immediately following the surgery, she was unable to sit up straight in a chair. Following the surgery, her balance decreased and she was restrained to a seatbelted wheelchair. she hallucinated frequently, and her cognitive skills diminished considerably, according to her family.

Who was the proper party to be financially responsible? The clinical trial was initiated by the treating neurologist at UCLA. The drug Spheramine was originally developed by Titan Pharmaceuticals, Inc. But, Titan entered into a partnership to develope the drug with a company called Berlax, Inc, which is the U.S. division of the German drug company, Scherring AG. Pre-operative testing was done at UCLA. The procedure was to be performed at Stanford University's medical center. But, the surgery was actually perfrormed at Tampa General Hospital by University of South Florida doctors. USF, Tampa General, and Berlex, Inc. all provided consent forms for the patient to sign. These consent forms were not consistent as to who would be responsible for future medical care in the event of an injury.

The Institute of Medicine has recommended a "no-fault compensation system" for individuals injured during clinical trials. Of course, the article reports the goal of a no fault system would be to resolve claims quickly without having to resort to lawsuits.

Originally posted at InjuryBoard by Mike Damaso

Birth Control Patch Warning Label to be Revised

Sandy Grinnell — Thu, 24 Jan 2008 05:47:34 GMT

The FDA has approved changes to the warning labels on the Ortho Evra Contraceptive Transdermal (Skin) Patch. The label will now include a warning that

users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

The warning comes from a study completed by the Boston Collaborative Drug Surveillance Program at the request of Johnson and Johnson, manufacturers of the Birth Control Patch. The results of the study of women between the ages of 15 and 44 corroborated an earlier study that there was a greater risk of VTE indicated for the women in the age bracket.

As a result of the warning, it is extremely important for women who are using or considering to use the birth control patch to discuss their own personal risks of having serious blood clots and the increased risk they have if using the patch.

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

Originally posted at InjuryBoard by Sandy Grinnell

Immediate Heparin Recall by Baxter Healthcare

Sandy Grinnell — Wed, 23 Jan 2008 10:35:29 GMT

Baxter Healthcare is voluntarily recalling nine lots of Heparin because of the reports of serious adverse reactions to the injections.

Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality

Baxter has not yet learned the cause of the reactions but is asking all healthcare propfessionals to discontinue using the affected lots immediately. A complete list is of the lots is available in the recall notice.

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

Originally posted at InjuryBoard by Sandy Grinnell

Popular Cholesterol Drug May Not Work

Diego Madrigal — Thu, 17 Jan 2008 06:18:02 GMT

The results of a 2 year clinical study revealed that the popular Cholesterol drug Zetia and the Zetia-containing pill Vytorin may be ineffective. Another interesting aspect of the study was that the pharmaceutical companies that produce the drugs kept missing deadlines to release the findings. The company originally blamed the complex data for the delay, but after news articles and Congress inquired as to the reason, the report was soon released. Millions continued taking the drug during that delay. In a press release the companies said that Zetia may actually contribute to plaque formation in arteries rather than reduce it. Cardiologists called the results "shocking." One prominent doctor said:

"This is as bad a result for the drug as anybody could have feared," said Dr. Nissen, a widely published researcher and senior consulting editor to the Journal of the American College of Cardiology. Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects, he said. Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed, he said.

Because of the results, many believe the drug company intentionally delayed releasing the findings from the study completed in April of 2006. This seems like a highly unethical move especially considering that the study indicated that the plaque in arteries grew nearly twice as fast as those who did not use Zetia.

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

Originally posted at InjuryBoard by Diego Madrigal

Vioxx Settlement Announced

Ed Normand — Wed, 14 Nov 2007 21:48:55 GMT

All over the United States consumers have sued for heart attacks and other serious injuries sustaned from using the drug Vioxx. This drug, heavily advertised as safe and effective, has been implicated in thousands of cases includiing allegations that it has caused widespread cases of death and permanent injury. The manufacturer of the drug vowed to fight all of the lawsuits in court. After winning some and losing some cases the drug maker has finally agreed to a global settlement to compensate consumers injured by the product. If you have sustained a heart attack or other injury while using Vioxx consult with a Board Certified Civil Trial Lawyer. Your injuries may have been caused by Vioxx and you and your family deserve the compensation for injuires caused by this drug.

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

Originally posted at InjuryBoard by Ed Normand

Trasylol Sales Stopped by Manufacturer

Ed Normand — Mon, 05 Nov 2007 13:01:19 GMT

Bayer has stopped sales of the anti-bleeding drug Trasylol. The sales ban is in response to a recent Canadian study documenting the risks of death in using Trasylol. The FDA could not advocate continued use of the product where the use of it is not outweighed by the risks. Product liability actions can be considered against drug manufacturers that sell a defective or dangerous drug. If you or a loved one sustained an injury or death while using Trasylol it may be beneficial to protect your family's rights by consulting with a lawyer. Find a lawyer experienced in product liability actions and one that will give you a free consultation. The information may help your peace of mind.

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

Originally posted at InjuryBoard by Ed Normand