An Alaska courtroom is revealing some interesting facts about Eli Lilly’s marketing practices concerning it’s schizophrenia drug, Zyprexa. What we’re learning is something we’ve suspected and been able to infer for years about the big drug companies. They are always looking to expand their market, often beyond what the FDA has approved. Now we’re beginning to see the actual inner workings of a large pharmaceutical company in their ruthless efforts to expand usage of their drugs. We’ve known that Lilly has aggressively campaigned to expand the approved market for Zyprexa since 2000. What we didn’t know is that a top official at Eli Lilly intimated (the language is couched and careful) that Zyprexa should be marketed for off-label use. The NY Times is reporting that an email sent by John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators. The email message is part of testimony in the state of Alaska’s case against Eli Lilly in which the state is seeking reimbursement for medicaid patients who used the drug and developed diabetes as a result.
As a result of finding contaminants in 20 of the 28 lots of heparin in a Chinese factory, the FDA will now inspect all heparing entering the United States. The contaminant remain unknown but it mimics the actual heparin and is known to have been linked to 19 deaths in the US as well as 80 allergic reactions in Germany. While this is a positive step in the right direction, the question must be asked, why does it take a crisis for the FDA to take proper steps and precautions to ensure the public safety? We all know the FDA is understaffed and underfunded but when it comes to public safety, the federal government shouldn’t tolerate such a breach in safety. When the nation’s drug supply or food supply is exposed to danger the federal government should have practices and procedures to make sure the public is kept safe from the threat. That’s just common sense. Heparin Recall Lawyer Class Action Lawsuit Attorney
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Agency gives new safety information on proper use of Tussionex as a cough suppressant
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events–including death–associated with the misuse and inappropriate use of this potent cough medication.
Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).
“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA’s Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”
Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.
Highlights of the FDA’s recommendations to health care professionals include:
Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.
Highlights of the FDA’s recommendations to patients include:
One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.
For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.
If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor.
The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.
This month, Ford Motor Co. issued another truck recall because the weld connecting a bracket and the front seat could potentially crack. This particular recall covers F-250 through F-550 Super Duty trucks. These trucks were manufactured in Ford’s Louisville plant. Ford trucks have been plagued by manufacturing defects and product recalls for the past few years making both investors and consumers jittery about the quality of the Ford products. Some of the recalls in the past included cracked fuel tanks, ignition switch defects, brake problems, drivetrain, and steering issues. This isn’t good for the industry and particularly troublesome for one of America’s best known manufacturing companies.
Heparin blood thinner video, from YouTube related to Baxter outsourcing.
Discussion on China and Germany related to Heparin recall.
Baxter Heparin Recall Lawyer Class Action Lawsuit Attorney
From The FDA:
FDA Public Health Update
Recall of Heparin Sodium Injection and Heparin Lock Flush Solution (Baxter)
The Food and Drug Administration is issuing this update to inform the public that
Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.
As a precautionary measure Baxter is also recalling its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection.
Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.
Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity. With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials. FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.
The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags. No adverse events have been reported in relation to the large volume solution. The heparin source manufacturer for the large volume solution is different from that of the products being recalled.
On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation. A description of the clinical settings and characteristics of the cases of serious adverse events that resulted in the public health advisory can be found at FDA Heparin Information Page
The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation. FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events. Heparin Recall Lawyer Class Action Attorney
I know I blogged about this just a day or so ago but I can’t let this one go. Bishop Gianfranco Girotti actually said that the first task of the bishops was to protect the reputation of the Catholic Church! I couldn’t believe what I was reading! This bishop actually admitted that the priority of the hierarchy was to protect its own reputation, the hell with the victims and their welfare. Once again, they betray themselves as men who have one mission and that is to protect and defend the church which they understand to be the bishops and the priests. The people are only accidental. The fact that such an important official would say such a thing in public belies a greater truth: the Church (understood as the bishops and priests) are only interested in one thing, and that is self-preservation. Victims of priest abuse are obstacles to that end. To say the church is in need of reform is indeed an understatement! Clergy Abuse Lawyer Sexual Abuse Attorney
While we’ve all heard of Medtronic’s problems with their Sprint Fidelis leads breaking and causing faulty electrical signals to the heart, this is a new one: pacemaker patients could be subject to a hacker remotely jolting their heart. According to a story published in the Wall St. Journal, it’s possible for someone to transmit radio signals and interrupt, stop, or otherwise alter the instructions that the doctor has programmed into the defibrillator. Presently, only doctors can buy a defibrillator from one of the major manufacturers such as Medtronic, Boston Scientific, or St. Jude Medical. However, this safety precaution does not prevent someone with the technological skill to hack into a defibrillator system because that system receives instructions via radio waves. As the Journal article mentions, this is a theoretical risk and not an actual risk since no one has reported such behavior.
In an effort to revive the practice of regular confession among Catholics, a bishop of the Apostolic Penitentiary, Bishop Gianfranco Girotti, has updated a list of sins to include those affecting the modern world. The Apostolic Penitentiary is a church court which oversees the sacrament of Penance or confession in the Catholic Church. The list includes drug pushers and users as well as the obscenely rich, manipulative genetic engineers and polluters. While Girotti spoke briefly of pedophilia he was quick to point out that the mass media has “blown up the issue to discredit the Church.” When I read his quote I was taken aback. Here’s a bishop of the Catholic Church blaming the sex abuse crisis on the media. I thought that that tactic had been discarded after it didn’t work for Cardinal Law in Boston. Even Cardinal Mahony hasn’t stooped to blaming the media for the sex abuse crisis. These types of reckless, irresponsible, and hypocritical comments lead me to believe that the church still doesn’t understand or appreciate its role in the crisis. Bishop Girotti should add another group to his “deadly sins” list that includes bishops, archbishops, and cardinals who willfully disregarded the welfare of minors by hiding, transferring, and covering up for sexually abusive priests. How can you have any credibility as a moral authority when your own house isn’t in order? If Bishop Girotti, who is speaking for the church as a whole, can’t appreciate the fact that the hierarchy of bishops and cardinals played a huge role in the sex abuse crisis, then he has no business lecturing the rest of us about “new sins”. Clergy Abuse Lawyer Clergy Physical and Sexual Abuse Lawyer
German Heparin Manufacturer Rotexmedica recalled heparin after allergic reactions were reported in Germany. Apparently, the ingredients from the German heparin came from Chinese plants. Baxter International in the U.S.A. also recalled heparin because of possibly contaminated or counterfeit ingredients from China. Currently, both U.S. and German authorities are investigating what might be counterfeit ingredients in heparin from China. Rotexmedica exports most of its heparin outside of Germany. Heparin is an injectable blood thinner. It is frequently used in kidney dialysis and open heart surgery. It can also be used to treat blood clots. Persons sickened or killed by counterfeit or contaminated heparin made by Baxter International may have legal claims in the U.S. It is unclear what rights Europeans may have against the German Manufacturer.