Orlando Personal Injury Lawyer - FDA & Prescription Drugs

Zicam Warning Issued by FDA

Diego Madrigal — Wed, 17 Jun 2009 10:46:49 GMT

Zicam nasal gel can destroy or severely damage your sense of smell according to a warning issued by the Food and Drug Administration. The warning only applies to the nasal products, which I actually use. The warning was based on 130 complaints received by the FDA from people and their doctors stating that following use of those products people suffered a condition called "ansomia," which is a loss of the sense of smell.

Since 1999, the maker of Zicam has payed $12 million to settle over 300 lawsuits. However, they have never recalled the drug. In fact, even after this FDA warning, the maker of Zicam refuses to recall the drug. Nevertheless, before Zicam markets their drug again they will have to gain FDA approval.

Like I have said, I used this exact product and have not noticed any problems- but then again, I have not been looking. I wonder how many people have not noticed and are suffering from loss of smell. Hopefully the makers of Zicam recall their product and find a way to issue it again in a safe form.

Originally posted at InjuryBoard by Diego Madrigal

Raptiva Voluntarily Recalled

Diego Madrigal — Tue, 21 Apr 2009 11:16:27 GMT

The makers of the drug Raptiva announced a volutary, phased in recall of the drug. The safety of the drug (which is used to treat psoriasis) has been called into question for years because it is linked to a rare, but sometimes fatal, neurological disorder. Just last month, Genentech, the maker of the drug had changed the FDA label to show an increased risk of the neurological disease, progressive multifocal leukoencephalopathy (PML).

In a statement, the makers of the drug said:

"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," Hal Barron, Genentech's senior vice president, development, and chief medical officer, said in a statement. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."

Hopefully, next time the commitment to patient safety includes putting a safe drug out in the marketplace. I understand that people will say that the drug's benefit outweighed the cost. However, I am one person who believes that no price can be put on a human life. In fact, this nation has also had that belief. For example, yearly we scrap shuttle launches at the cost of millions of dollars because of the chance of death. Likewise, only 2,000 people nationwide were taking Raptiva, according to the manufacterer's own numbers so the fact that there have been multiple deaths and others affected is stunning.

Originally posted at InjuryBoard by Diego Madrigal

Personal Injury Lawsuit Filed Against Makers of Byetta(R)

Sandy Grinnell — Mon, 08 Sep 2008 16:58:27 GMT

A Virginia man has filed a personal injury lawsuit in San Diego Superior Court against Amylin Pharmaceuticals, the manufacturer, and Eli Lilly and Company, the co-marketer, of the injectable diabetes drug Byetta(R). This personal injury lawsuit may be the first of its kind against the manufacturer of a pharmaceutical company.

In 2007 Amylin negotiated with the FDA to inform patients of the risk of acute pancreatitis by adding it to the "precautions" on the ByrettaR warning label provided to physicians and patients . This addition to the warning label was a direct result of 30 cases of acute pancreatitus from using the drug.

The personal injury lawsuit alleges the manufacturer "failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk."

The plaintiff, who was prescribed ByettaR for his diabetes, was hospitalized in December, 2007 for pancreatitis, or inflammation of the pancreas. Pancreatitis can cause bleeding and even death. The plaintiff's attorney, Thomas M. Moore of Moore Labriola LLP, states "it is pretty obvious that the label change in 2007 was not adequate."

Coincidently, two days after the lawsuit was filed, the FDA reported that six cases of hermorrhagic or necrotizing pancreatitis in patients who were prescribed ByettaR and two of those six victims died. And just yesterday Amylin and Lilly reported that four more people have died from taking ByettaR.

Originally posted at InjuryBoard by Sandy Grinnell

Report Recommends Eliminating Free Gifts for Doctors at Medical Colleges

Sandy Grinnell — Mon, 28 Apr 2008 12:15:43 GMT

According to the New York Times, for years pharmaceutical companies have courted medical schools, professors, residents and students with free meals, trips and gifts. Reportedly, these expenditures range in the billions of dollars, far exceeding their expenditures on research and consumer marketing.

They also provide talking points and slide shows for physicians' speeches on pharmaceuticals or medical devices for which the physcian may be paid a substantial fee. Doctors have even published articles which were actually authored by an employee of the pharmaceutical company, which is known as "ghost writing."

Do these gifts, speeches and ghost writing create a conflict of interest for the medical schools and physicians? The Association of American Medical Colleges (AAMC) thinks that they do. In a report by the AAMC Task Force on Industry Funding of Medical Eduation, it recognizes that there has been an ever-increasing reliance on the health industy for its funding. It states that -

"This reliance raises concerns because such support, including gifts, can influence the objectivity and integrity of academic teaching, learning and practice, thereby, calling into question the commitment of academia and industry together to promote the public's interest by fostering the most cost-effective, evidence-based medical care possible."

I find it interesting that whenever the significant increases in the health costs in this country, particularly prescription medications, are discussed, the pharmaceutical companies usually bring up the huge costs of research as the main reason for the increases. Nowhere have I ever heard them say that they spend more on wooing the medical schools and physicians than they do on research.

This report by the AAMC recommends that medical schools implement strict conflict of interest rules for their faculty, staff and students to eliminate this undue influence. Of course, while the schools are not necessarily required to heed this advice, it is concluded that many of them probably will. Let's hope that independent physicians follow their lead. As reported by the president of the Institute on Medicine, Dr. David Rothman at Columbia University, "We're hoping the example set by academic colleges will be contagious."

Originally posted at InjuryBoard by Sandy Grinnell

FDA Condemned for Lack of Inspections

Sandy Grinnell — Thu, 24 Apr 2008 05:16:00 GMT

Food and Drug Administration (FDA) officials were raked over the coals this week for the administration's lack of inspections of foreign drug manufacturing plants. Both Republicans and Democrats expressed their concern that U.S. plants are inspected every two years, while some foreign manufacturers haven't seen a U.S. inspector for up to 10 years, and some maybe never. In fact, 81 deaths in the U.S. have been attributed to reactions from contaminated heparin that came from a factory in China that had never been inspected.

FDA Commissioner Andrew C. von Eschenback responded that he agreed more foreign inspections need to be made, but not every two years like the House Energy and Commerce Commission was suggesting. Rep. John Shimkus, R-Illinois, answered back that he felt the balance of inspections in the U.S. to those of foreign companies did not match the "risk priorities."

Originally posted at InjuryBoard by Sandy Grinnell

1 out of 15 Hospitalized Children May Be Harmed by Drug Mistakes

Diego Madrigal — Mon, 07 Apr 2008 11:34:57 GMT

A new detection mechanism for harmful or incorrect use of medicines in hospitals has shown that 1 in 15 hospitalized children are the victims of mix-ups, overdoses, and harmful reactions to drugs prescribed during hospital stays. This translates to 540,000 kids afflicted every year. The report also indicates:

Patient safety experts said the problem is likely even bigger than the study suggests because it involved only a review of selected charts.Also, the study didn't include general community hospitals, where most U.S. children requiring hospitalization are treated.

Luckily, most of the reactions are not severe and cause no damage. But, there is always the potential that something tragic could occur. When children are admitted to a hospital it is definitely a worrisome and troubling time for parents. This news will surely make that time even more stressful, however the best way to ensure something like this is prevented is to ask caregivers what they are giving your child and why when they treat your child.

Originally posted at InjuryBoard by Diego Madrigal

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