Diabetes treatment Januvia and Janumet ( sitagliptin / metformin ) could be linked to occurrences of acute pancreatitis, According to the FDA.
This is the same problem that sunk sales of Amylin Pharmaceuticals Inc.’s Byetta.
88 cases of acute pancreatitis were reported to the fda in Januvia patients between 10/06 and 02/09.
The agency is working with Merck to include new warning information on the drug’s label.
“It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases,” the agency said, in a statement.
Patients who take these drugs are advised by the FDA to discuss this news with thier doctor and advice that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.
Still, the agency said it is unknown whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.
“Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event,” the agency said.
What is sitagliptin?
Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.
Sitagliptin is for people with type 2 diabetes (non-insulin-dependent) diabetes. Sitagliptin is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.
If you or someone you care about has taken a medication and suffered adverse side effects, we urge you to contact our law offices today. You may have actually injected or ingested a defective drug; if so, you could be entitled to monetary compensation for any pain and suffering that resulted from your experiences with the product.
Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.
Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.
Authorities called Pfizer a repeat offender, noting it is the company’s fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.
As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.
“They were entertained with golf, massages, and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.
Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.
To prevent backsliding this time, Pfizer’s conduct will be specially monitored by the Health and Human Service Department inspector general for five years.
In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.
Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can help the American public at a time when budgets are tight and health care costs are rising.”
Perrelli announced the settlement terms at a news conference with federal prosecutors and FBI, and Health and Human Services Department officials.
The settlement ends an investigation that also resulted in guilty pleas from two former Pfizer sales managers.
Officials said the U.S. industry has paid out more than $11 billion in such settlements over the past decade, but one consumer advocate voiced hope that Wednesday’s penalty was so big it would curb the abuses.
“There’s so much money in selling pills, that there’s a tremendous temptation to cheat,” said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.
“There’s a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship.”
The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.
Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.
Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.
A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.
The $1 billion in civil penalties was related to Bextra and a number of other medicines.
A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.
Pfizer’s top lawyer, Amy Schulman, said the settlements “bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines.”
In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures.”
In financial filings in January, the company had indicated that it would pay $2.3 billion over the allegations.
The civil settlement announced Wednesday covered Pfizer’s promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.
The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.
The allegations came to light thanks largely to five Pfizer employees and one Pennsylvania doctor, who will now share $102 million of the settlement money.
FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to “speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”
Stabilet Infant Warmer Draeger: Class 1 recall due to the reasonable probability that use of these products will cause serious injury or death.
The FDA issued a Class 1 recall models of the Stabilet infant warmer because they may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire.
On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen — widely known under the brand name Tylenol — and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.
Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.
History of Acetaminophen Liver Failure
In the late 1990s, research began to show that acetaminophen was a major cause of acute liver failure in the United States, with up to half of the cases due to accidental overdose. Responding to these concerns, FDA took a number of steps to reduce the incidence of liver injury related to acetaminophen.
In 1998, FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning in labeling.
The warning stated: Acetaminophen. ‘‘Alcohol Warning’’: ‘‘If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.’’
In 2002, FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.7 The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified. FDA and manufacturers were also advised to educate consumers and health professionals about the risk of liver injury from acetaminophen.
In early 2004, FDA launched a public education campaign to help consumers use acetaminophen more safely. By most standards, the campaign would be considered small, due to budgetary constraints. It was also limited by reluctance on the part of some commercial outlets to provide a venue for FDA’s message about acetaminophen toxicity as the product was sold or promoted in those outlets. Nonetheless, FDA has continued to expand efforts to improve public education about acetaminophen overdosing and liver injury and has recently updated the acetaminophen information on FDA’s Web site.
In 2004, FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that: (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs patients to avoid drinking alcohol during prescription use.8 FDA was informed by the National Association of Boards of Pharmacy that, as of February 2008, no states had implemented regulations related to the request.
In December 2006, FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container and outer carton identify acetaminophen when it is an ingredient.9 The final version of the regulation is currently under review.
In 2007, the Director of FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working group in CDER to continue to evaluate the issues associated with acetaminophen-related liver injury and consider additional steps FDA could take to decrease the number of cases of acetaminophen-related liver injury. The working group considered detailed reviews of the issues from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products as part of its deliberations.
Acetaminophen /Tylenol – Black Box Warning Recommended by the FDA
The FDA has recommends that the a black box warning is added to the labels of prescription pain and cold products that contain acetaminophen wich is widely known under the brand name Tylenol.
The FDA states that there is a signifigant health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products.
Because acetaminophen is important for the use of treating pain and fever they do not want to remove it from the market.
Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
Acetaminophen is the active ingredient in Tylenol.
It is also found in many other over-the-counter medications you can buy at the drug store and in prescription drugs your doctor prescribes:
Common names include:
Actifed
Alka-Seltzer Plus
Benadryl, Butalbital
Co-Gesic
Contac
Darvocet
Excedrin
Fioricet
Lortab
Midrin
Norco
Percocet
Robitussin
Sedapap
Sinutab
Sudafed
TheraFlu
Unisom With Pain
Vick’s Nyquil
Vick’s DayQuil
Vicodin,
Wygesic
Zydone
Acetaminophen in overdose can seriously damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.
Accordning to Research, hundreds of people each year are diagnosed with acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.
Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.
Inferior Vena Cava (IVC) filters are Medical devices which are meant to help prevent blood clots from getting to the lungs.They are placed in patients who are at high risk for blood clots in the lungs.
Defective IVC Filters:
The two defective products are:
Bard Peripheral Vascular Recovery (Recovery TM)
G2 Filter (G2TM).
Why are they considered defective?
The IVC filters are said to have caused severe injuries and side effects including:
Filter Movement
Fracture of the Filter
Lung and Heart Puncture
A few cases resulting in death
Reports by the FDA and Bard indicate that Bard IVC filtershigher incidents of these injuries than any other IVC filters.
Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions againstdrug companies than the Bush administration did.
The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.
In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.
Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”
The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.
“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”
Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.
The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.
But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.
An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.
Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.
“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”
Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.
June 3, 2009 – FDA Alert: Propylthiouracil -Induced Liver Failure
According to the FDA Propylthiouracil (PTU) can cause serious liver injury, including liver failure and death.
PTU is used to manage hyperthyroidism associated with Grave’s disease. It is also used to decrease symptoms of hyperthyroidism in preparation for surgically removing the thyroid gland or before inactivating the thyroid gland with radioactive iodine therapy
Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared with methimazole (MMI).
The FDA has identified 32 AERS cases (22 adult and 10 paediatric) of serious liver injury associated with PTU use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the paediatric patients, 1 case resulted in death and 6 in liver transplants.
In contrast, for MMI only 5 AERS cases of serious liver injury were identified. All five cases were in adult patients and 3 resulted in death.
Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. PTU may also be used when it is not advisable to remove the thyroid gland.
Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first 6 months after initiation of therapy (fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising or yellowing of the eyes or skin).
In general, PTU is considered second-line drug therapy except in patients who are allergic to or intolerant of methimazole. Rare cases of embryopathy, including aplasia cutis, have been reported with use of MMI during pregnancy, while no such cases have been reported with PTU use. Thus, PTU may be more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.
Agranulocytosis is potentially the most serious side effect of Propylthiouracil therapy. Patients should be instructed to report any symptoms of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. The drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis. The patient’s bone marrow function should be monitored. Propylthiouracil can cause fetal harm when administered to a pregnant woman.
Because the drug readily crosses placental membranes and can induce goiter and even cretinism in the developing fetus, it is important that a sufficient, but not excessive, dose be given. In many pregnant women, the thyroid dysfunction diminishes as the pregnancy proceeds; consequently a reduction of dosage may be possible. In some instances, Propylthiouracil can be withdrawn 2 or 3 weeks before delivery.
On April 18, 2009, the FDA held a public workshop with the American Thyroid Association (ATA) to discuss PTU-related hepatotoxicity. The FDA is continuing to monitor these serious reported adverse events and working to make changes to the PTU prescribing information, particularly for use in paediatric patients. Also, the ATA plans to update its treatment guidelines for Graves’ disease in the upcoming months.
Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU and MMI were approved in 1947 and 1950, respectively.
Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.
The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.
Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.
Consumers with the recalled product should return these products to their pharmacy or place of purchase.
According to the FDA, sharing insulin pens can put patients at risk of transmitting hepatitis viruses, HIV, and other blood-borne pathogens.
Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user.
The FDA is working with the Centers for Disease Control and Prevention, professional societies and health care organizations to reinforce patient and health care provider education about proper and safe use of insulin pens.
The FDA alerted healthcare officials that makers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.
Metoclopramide usage of a long period of time has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body. Even if you have not taken the drug for a while it sometimes can still occour.
The symptoms are often if not almost never reversible and there is no known treatment.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections.
The Makers will be required to use a risk evaluation and mitigation strategy [REMS] to make sure that patients are provided with a medication guide that discusses this risk.
Makers include Baxter International Inc (BAX.N) and several generic drug companies.
More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.
Tardive tourettism is a tic disorder that can closely mimic Tourette Syndrome, sometimes to the point where the two can only be distinguished by the details of their onsets.
Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.
The legislation would expand FDA access to food company records and tests, give it authority to order mandatory food recalls, and increase funding.
Lawmakers and critics say this bill is a step in the right direction, but a step that should have been taken years ago.
Industry is open to change, said Scott Faber, a top lobbyist for the Grocery Manufacturers Association, which represents large food and beverage companies.
“The food industry recognizes that we need to give FDA new powers and new resources to address new challenges,” Faber said.
Businesses are concerned about reorganizing the entire system. The priority should be strengthening the current agencies before rearranging them, he said.
The GAO, the investigative arm of Congress, recommended two years ago that Congress re-examine the system. It said 76 million people are sickened by food-borne illness each year, and 5,000 die.
But few changes have been made. And despite the salmonella outbreak, even the lawmakers urging changes say a streamlined new agency is unlikely any time soon.
In related News, a study suggests that the FDA should have more oversight on supliments. More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the Food and Drug Administration does not have enough authority to ensure that the products are safe, and it should seek more oversight power, according to a government audit released Tuesday.
In January, the Food and Drug Administration issued a warning on 69 weight-loss products. The agency, however, cannot require manufacturers to remove supplements from shelves.
The new report from the federal Government Accountability Office acknowledged that the F.D.A. had taken some steps in the last few years to supervise the supplement industry more closely — but the report said those steps did not go far enough.
In the first 10 months of last year, for example, the audit said the F.D.A. received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations.
Congress requested the evaluation of how the FDA regulates these popular products. The Nutrition Business Journal reports that 79% of adult Americans take dietary supplements.
The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don’t have to tell the FDA what products they sell or ingredients they use.
The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died.
All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.
The FDA is reviewing this latest information. The agency will take appropriate steps to:
ensure that the risks of Raptiva do not outweigh its benefits;
that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
that health care professionals carefully monitor patients for the possible development of PML.
The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system.
These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.
Since the approval of Raptiva (efalizumab) in October 2003, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.
Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years. None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.
PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.
Raptiva works by affecting T-cells in the immune system. The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.
Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva. At the time of approval, a total of 2,764 patients had been treated with Raptiva. Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.
Healthcare providers should, in the interim, be aware of the following information and advice:
Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.
Inform patients using Raptiva of the potential risk of developing PML.
There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
Monitor patients being treated with Raptiva for the onset of neurologic symptoms. Discontinue Raptiva if PML is suspected.
Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks. Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.
Patients using Raptiva should:
Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
Contact their healthcare provider immediately if they experience these symptoms.
Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.
According to Reuters, Genentech Inc (DNA.N) is developing plans to minimize the risks of a deadly infection reported in patients who took the company’s Raptiva psoriasis drug, a company spokeswoman said on Thursday.
The European Medicines Agency recommended suspension of Raptiva’s marketing approval after three confirmed reports of progressive multifocal leukoencephalopathy, or PML. U.S. regulators said they were reviewing the cases.
“We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan,” Genentech spokeswoman Tara Cooper said.
Genentech markets Raptiva in the United States. Merck Serono, a unit of Merck KGaA (MRCG.DE), holds marketing rights to Raptiva in Europe. (Reporting by Lisa Richwine, editing by Lisa Von Ahn)
Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with RAPTIVA . These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with RAPTIVA. If a patient develops a serious infection, RAPTIVA should be discontinued and appropriate therapy instituted.
Progressive Multifocal Leukoencephalopathy PML) resulting from JC virus infection has occurred during therapy with RAPTIVA.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html
Update for February 9, 2009 (next web update will be available Thursday, February 12)
Today’s Highlights
Case count is 600 in 44 states with latest confirmed, most recent reported illness beginning on January 23, 2009
Major national brands of jarred peanut butter found in grocery stores are NOT affected by the Peanut Corporation of America (PCA) recall.
Consumers may use FDA’s online database* to see if foods are on the recall list. Those without Internet access may call 1-800-CDC-INFO (available 24 hours a day, seven days a week) for product recall information.
The Centers for Disease Control and Prevention (CDC) has been receiving reports, from many states, of illnesses caused by a type of Salmonella called Salmonella Typhimurium. Several deaths may also be associated with this outbreak. Tests indicate that the people who became sick may have eaten the same contaminated food, because they were infected with the same strain of Salmonella Typhimurium (i.e., the strain of Salmonella shared the same genetic “fingerprint”). Additional information on the numbers of illness and the states in which they occurred can be found at www.cdc.gov/salmonella/typhimurium/.
Is the salmonellosis outbreak definitely linked to peanut butter?
A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and CDC enabled FDA to confirm that the sources of the outbreak were peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia, processing plant. Peanut paste is a concentrated product consisting of ground, roasted peanuts that is distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream.
12/15/07 – Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.
The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.
“The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals.”
CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.
“We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution,” said Woodcock.
In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study’s findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.
If you or someone you love was injured by the severe side effects of Defective Drugs you may be entitled to pursue financial compensation for your pain and suffering, but if you wait too long laws called statutes of limitations could prevent you from pressing your case. Let a dedicated and experienced defective drug attorney help you get you the restitution you deserve.
Digitek – A condition known as digitalis toxicity, symptoms of this condition include nausea, vomiting, dizziness, and bradycardia, which is a dangerously low resting heart rate.
Heparin FDA Recall -The Heparin recall was initiated because the multiple-dose injections allegedly lead to serious and almost immediate side effects
Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. PTU may also be used when it is not advisable to remove the thyroid gland.
FDA MedWatch – 2009 Safety Alerts for Human Medical Products
