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.
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.
A California pistachio processor issued a nationwide voluntary recall on Tuesday of pistachios due to potential salmonella contamination.
The U.S. Food and Drug Administration and the California Dept. of Public Health are investigating the matter. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios, the FDA said.
The recalled nuts were shipped on or after Sept. 1, 2008 by Setton Pistachio of Terra Bella Inc.
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 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
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
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.
The U.S. Food and Drug Administration recently issued Raptiva Side Effects Warning 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).
No illnesses associated with this product have been reported to date however as a precaution QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine.
Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.
The White Rabbit Creamy Candy is sold in 8 or 16 oz packages. All other flavors of White Rabbit Candy, including Assorted (Chocolate, Coconut, and Coffee), Red Bean, Coffee, Corn, Lychee, Mango and Strawberry are sold in 7 oz. packages. All packaging has a logo of a white rabbit on the front with the words “White Rabbit”.
The recall was initiated after it was discovered that product was contaminated with Melamine.
Consumers who have purchased White Rabbit Candy are urged to return it to the place of purchase for a full refund or discard it in their trash.
Consumers with questions may contact the company at (650) 697-6633.
OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.
Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN.
Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range.
New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.
Update Aug. 27 The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who’d been taking the medication.
Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.
The FDA is warning patients taking Byetta that there have been “very rare case reports of pancreatitis with complications or with a fatal outcome.”
Six more reports of patients developing pancreatitis while taking Byetta. Two patients died and 4 were recovering.
Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.
The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.
However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.
Amylin and Eli Lilly said in a statement that patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.
The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.
If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.
Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals”
Byetta Lawyers are available for free consultations for people who have been affected by the side effects of this drug.
The (FDA) anounced to the makers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.
Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
Many people agree that the FDA is simply not doing enough about drugs like this.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.
“The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”
The FDA released an advance Communication regarding an Ongoing Safety Review to inform health care professionals that the Agency is looking into a potential connection between the use of Tumor Necrosis Factor (TNF) blockers and the maturation of lymphoma and other cancers in children and young adults. FDA is investigating around 30 reports. The reports were presented to the FDA’s Adverse Event Reporting System during a ten-year period, starting in 1998 through April 29, 2008.
These reports identify cancer occurring in children and young adults who started taking TNF blockers (and other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), while they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn’s disease or other diseases. Around 1/2 of the cancers were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma.
Long-term studies are required to render conclusive replies about whether TNF blockers increase the happening of cancers in children since cancers could take a long time to arise and may not be observed in short-term studies. Until the evaluation is finished, healthcare providers, parents, and caregivers should be mindful of the conceivable risk of lymphoma and other cancers in children and young adults when choosing how to better treat these patients.
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.
