Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

Premium Edge Cat Food Recalled

If you have a furry little friend who eats Premium Edge cat food, you’ll want to read this:

On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the company’s posted announcement of September 23 when the initial recall information was provided.

Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. At the first stage the cat may show decreased appetite, salivation, vomiting, and weight loss. Later, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. These ultimately may result in the death of the animal if left untreated. If your cat has consumed the recalled product and has these symptoms, please contact your veterinarian.

The affected products were distributed in Maine, New Hampshire, Vermont, Massachusetts, Connecticut, Rhode Island, New Jersey, Maryland, Delaware, New York, Pennsylvania, Virginia, Alabama, Tennessee, North Carolina, South Carolina, Georgia, Florida.

The affected date codes were RAF0501A22X 18lb. (BB28NOV10), RAF0501A2X 6 lb. (BB28NOV10), RAF0802B12X 18lb (BB30FEB11), RAH0501A22X 18 lb. (BB28NOV10), RAH0501A2X 6lb. (BB28NOV10, BB30NOV10, BB08DEC10)

To date, 21 cases of thiamine deficiency in cats have been reported and confirmed by Diamond. The reports have been confined to the New York and Pennsylvania areas and none have been received since October 19.

Diamond has tested the product and found the cat foods were deficient in thiamine. Samples taken by the FDA indicated that there were additional lots with insufficient levels of thiamine. No other complaints have been reported on any other product manufactured by Diamond Pet Foods.

Consumers who have purchased the affected lots are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-977-8797, Monday-Friday, 8:00 am to 5:00 pm Central Time.

Source: Diamond Pet Foods Announces Recall of Premium Edge Adult Cat and Premium Edge Hairball Cat Food

More on the link between Meridia and cardiovascular events

As always, consult your doctor before you even think about taking yourself off a drug.

WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety review of the weight-loss drug Meridia, which is made by Abbott Laboratories (ABT).

The FDA siad it was reviewing preliminary data from a recent study that suggests patients using the drug have a higher number of cardiovascular events such as heart attacks and strokes compared to patients not on the drug.

Source: FDA Reviewing Safety Of Weight-Loss Drug Meridia

New Warning for Users of Meridia

This is fresh from the FDA.  If you’re using Meridia (Sibutramine) you may want to bring this up with your doctor:

FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m², or BMI ≥ 27 kg/m² with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.

Read the MedWatch safety summary, including a link to the FDA Early Communication about an Ongoing Safety Review, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm

Notice I said to bring it up with your doctor: N E V E R stop using medication without first talking it over with your doctor.

New Information About Drugs Used In Shoulder Pain Pumps

One area I haven’t written much about yet is the association of chrondrolysis with drugs used in certain shoulder pain pumps.  Here’s some fresh information on that topic from the FDA:

FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm

Some Lots of Vicks Sinex Nasal Spray Recalled

If you have any Sinex Nasal Spray, you should check to make sure it’s not one of the recalled bottles:

Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Consumers should simply discard the affected product as they would any over the counter medicine. Customers who have the affected lots can call P&G for a replacement coupon or refund.

Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191413.htm

Do you take Plavix and Prevacid? Then read this warning.

Fresh from the FDA a few minutes ago…

[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid.  New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. 

Recommendations for healthcare professionals are provided in the "Information for Healthcare Professionals" sheet.

Read the MedWatch safety summary, including links to the FDA Information for Healthcare Professionals sheet, Public Health Advisory, and Follow-up to the January 26, 2009 Early Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm

NO - You Can NOT Eat a Fentanyl Patch

People keep finding my blogs by searching for things like "Can you eat a fentanyl patch?" 

NO!

Eating a fentanyl patch has a VERY good chance of killing you.  The patches are designed to deliver fentanyl at a constant amount over a period of three days.  Eating it will give you the full dose all at once. 

I have personally seen autopsy reports and death certificates from people who have eaten fentanyl patches.  One poor guy was only 18 years old and experimenting with friends.  He died within hours of eating the patch.

Please, if you're considering eating a fentanyl patch, or considering injecting the fentanyl gel - DON'T.

News about link between Byetta and acute renal failure

Just got this in my email from the FDA:

Byetta (exenatide) - Renal Failure

Audience: Endocrine and nephrology healthcare professionals

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

• Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
• Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
• Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
• Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm

Rituxan and progressive multifocal leukoencephalopathy

From the FDA:

Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.

Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

More at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm

FDA Issues Warning on Progressive Multifocal Leukoencephalopathy (PML) and Tysabri

Do you subscribe to FDA warning alerts?  Well, if not, you should.  Because if you did you’d get informative emails like this one:

Audience: Neurological healthcare professionals, patients

[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.  Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.  From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.

Read the MedWatch safety summary, including a link to the "Information for Healthcare Professionals" page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182667.htm

Black Box Warning for Amputation Finally Ordered

It came a little late for Diana Levine, but at least it finally came.

TRENTON, N.J. — Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

Wyeth had appealed the case up to the Supreme Court after a Vermont woman named Diana Levine, who once played the guitar and piano professionally, sued because she had to have her right arm amputated after being injected with Phenergan. Levine's lawsuit, which claimed she wasn't sufficiently warned of the risks of using Phenergan, won her a $6.7 million jury award.

Source: The Associated Press: FDA requires strong amputation warning on sedative

Duragesic / Fentanyl patients should stay away from grapefruit, heat

In February, the FDA approved changes to the warning label for the Duragesic (Fentanyl) pain patch, including adding warning patients using the patch not to drink grapefruit juice or expose the patch to a direct heat source.

Dose increases should be approached with caution, and patients should avoid grapefruit or grapefruit juice... (Emphasis added.)

. . . .

Patients and caregivers should also be advised to avoid exposure of the patch application site to direct external heat sources because of the potential for temperature-dependent increases in fentanyl release that may result in overdose and death. (Emphasis added.)

Heat sources include heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds; sunbathing and hot baths should likewise be avoided. Patients in whom fever or increased core body temperature from strenuous exertion develops should be monitored for opioid adverse events, and fentanyl dosage should be adjusted accordingly.

Source: FDA Safety Changes: Ultram ER, Reyataz, Duragesic

 

Digitek (Digoxin) Recall Information

Safety Alert: Digitek Recalled in April of 2008

On April 25th of 2008, Actavis Totowa, LLC announced a Class I Recall of Digitek tablets.  A Class I Recall occurs when there is an immediate risk of death or injury from a drug or medical device.

In this case, Actavis announced the recall because certain batches of Digitek tablets contained double the dose of the active ingredient Digoxin.  This high dosage can lead to injury or death from Digitalis Toxicity. 

Actavis hired a company called Stericycle to handle the recall.  They can be reached at  1-888-276-6166, Monday through Friday, from 8am to 5pm Eastern Standard Time.  Actavis has not announced which lots have been contaminated, but Stericycle is only issuing refunds to customers who had prescriptions filled from March of 2006 through April of 2008.  You can read the actual recall notice here.

If you still have any Digitek from that time period, it is critically important that you do not take it.  You should contact your doctor, your pharmacy, or Stericycle to determine how to replace the pills.  If possible, you should keep the defective pills in a safe place in case it becomes necessary to file a lawsuit against Actavis.  But make sure they’re locked in a safe place where there is no risk anyone may take them.

How do I know if I’ve been injured by Digitek?

The most serious side-effect of a Digoxin overdose is death.  If a loved one passed away while taking Digitek, it’s possible that the double-dose of Digoxin contributed to the death.  If the death certificate lists “Digitalis Toxicity” as one of the causes of death, the odds are very high that Digitek is at least partially to blame.  There are other signs that Digitek contributed to someone’s death; feel free to contact me if you’re concerned that Digitek caused the death of a loved one.

Other symptoms of a Digitek overdose include:

• Heart problems, such as dysrhythmia and cardiac arrest.
• Severe nausea, diarrhea, vomiting, etc.
• Visual problems, such as blurred vision and seeing “halos.”

People with kidney problems, the elderly, and women are most likely to have suffered an injury or death due to Digitalis Toxicity.  Especially those who were using the 0.250mg dose of Digitek as opposed to the 0.125mg dose, since the 0.250mg dose actually contained 0.500mg of Digioxin.

Should I file a Digitek lawsuit?  Do I need a lawyer?

Whether to file a lawsuit over Digitek is a decision you should make after contacting an attorney familiar with Digitek litigation.  I’m fortunate enough to have good relationships with several attorneys who are qualified to help people injured by Digitek.  If you email me, we can talk about your potential case and I’ll match you with a lawyer who I believe will take good care of you.  Unlike most attorney lead-generation services, I do not get paid by anyone to refer them your case.  And because I’m a law student and not yet an attorney, it would be illegal for me to get a “cut” of any recovery in your case.  All I ask from you is that you contact your elected representatives and tell them you oppose FDA Preemption, which would eliminate most lawsuits over prescription drugs.

Remember, I am not yet a lawyer, so emailing me does not and can not create an attorney-client relationship.  Nor am I going to offer you any legal advice.  Instead, I’m going to listen to your story and give you the names and contact information of attorneys I think can help you and your family get through this difficult time.

Double the dose?  How did this happen?

While the incident is still being investigated by the FDA, all signs point towards poor quality control at the Actavis manufacturing facility.  In August of 2006, and again in February of 2007 the FDA sent warning letters to Actavis explaining that the company was violating FDA rules on the manufacture and inspection of prescription drugs.  In other words, it looks like Actavis was simply being sloppy.

You can read the August letter here, and the February letter here.  Some of what the FDA found would be comical if it weren’t for the deadly result of their sloppiness: One of the precision machines used to make medication was repaired with duct tape.  The letters give the strong impression that Actavis was cutting corners in their manufacturing facility. 

What do the Recalled Digitek Pills Look Like?

The .125mg Digitek pills that were recalled are yellow and are marked with B 145 on the front:

The .250mg Digitek pills that were recalled are white and are marked with B 146 on the front: