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2008 | 2007 | 2006 | 2005
December 2005
Accidental Childhood Acetaminophen Overdoses
The Institute for Safe Medication Practices (ISMP) is issuing a warning concerning the potential confusion of acetaminophen (APAP) dosing to children. The overdose of APAP, although rare, is a very real risk. There are some potential sources of confusion in acetaminophen dosing.
The infant’s formulation is about three times more potent than the children’s formulation, yet the labeling on these two different formulations appears very similar (160mg per two droppersful and 160mg per 5ml). Parents often confuse the two different formulations and administer too much of the concentrated infant’s drops.
In addition, parent’s need to ensure that they are using an accurate instrument of measurement, because items such as household teaspoons and the measuring cups supplied with children’s Tylenol® liquid are inexact. An oral syringe may be more accurate than the dosing cups provided by the manufacturer. As for the infant drops, keep in mind that the term “dropperful” does not mean a full dropper, as the maximum fill line (1.6ml) is only one half of the way up the dropper and often difficult to see. Parents need to be cautioned against using multiple products containing acetaminophen at the same time.
Common signs of APAP toxicity are anorexia, nausea, vomiting, malaise, right upper-quadrant pain, and jaundice. Practitioners should educate parents about the different APAP formulations and make it clear how the concentrations of these formulations are labeled on the product. They should also emphasize the serious consequences of an overdose, how to recognize a dosing error, and when to call a poison control center for advice.
For more information on this topic, please refer to www.ismp.org.
Important Prescribing Information: Paxil® and Paxil CR®
On December 8, 2005, the Food and Drug Administration (FDA) issued a Public Health Advisory regarding early results of new studies on paroxetine. The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
The FDA is awaiting the final results of recent studies and gathering additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine. In the interim, the FDA recommends the following:
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.
Novoseven Labeling Update
Novo Nordisk and the Food and Drug Administration recently notified health care professionals of a labeling revision for their coagulation product, Novoseven (coagulation factor VIIa recombinant). The labeling update was in the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for the product based on post-marketing surveillance. The updated information included adverse effect potential, including thrombotic and thromboembolic events. This updated information was based on a study that included elderly, non-hemophiliac, intracerebral hemorrhage patients. The adverse events in the study included arterial throboembolic events, myocardial ischemia, myocardial infarction, and cerebral ischemia and/or infarction with the use of Novoseven.
For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
Information received from http://www.fda.gov/
Aranesp, Epogen, and Procrit Labeling Update
The manufacturers of Aranesp (Amgen), Epogen (Amgen), and Procrit (Ortho Biotech), along with the Food and Drug Administration, recently notifed health care professionals of a labeling revision for their products. The revision was made to the WARNINGS, PRECAUTIONS, ADVERSE REACTION, and DOSAGE AND ADMINISTRATION sections of the prescribing information. The updated information includes reports, mainly in chronic renal failure patients, of pure red cell aplasia and severe anemia, with or without cytopenias, associated with neutralizing antibodies to erythropoietin in patients using these products. Treatment and evaluation recommendations can be obtained in the prescribing information of these products.
For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
Information received from http://www.fda.gov/
FDA Alert- Clarithromycin
The Food and Drug Administration issued an alert in December 2005 regarding the antibiotic clarithromycin (Biaxin). This alert was based on a recently published study in the British Medical Journal (CLARICOR study) citing increased mortality in patients receiving a two-week course of therapy with clarithromycin compared with patients who received placebo. The details of this effect are not clear at this time. Previous trials to show if antibacterials prevent heart disease or increase mortality have not had statistically significant results. The FDA is not currently recommending any changes in the use of clarithromycin and is attempting to gather additional information.
For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
To read the complete article from the British Medical Journal
http://bmj.bmjjounrals.com/chi/rapidpdf/bmj.38666.653600.55v1
Information received from http://www.fda.gov/
November 2005
Flomax
The FDA and Boehringer Ingelheim recently notified health care professionals regarding labeling updates for Flomax (tamsulosin). Flomax, an alpha-1 blocker, is indicated for treating the signs and symptoms of benign prostatic hyperplasia. There have been observations of a surgical condition called Intraoperative Floppy Iris Syndrome (IFIS) when a patient is taking Flomax and undergoing phacoemulsification cataract surgery. This surgical condition was also observed in patients who had discontinued their alpha-1 blocker prior to the cataract surgery. The labeling recommends that male patients being considered for surgery have a complete medical history taken that includes specific questions about their past or current use of alpha-1 blockers. If the patient does have a medical history that includes Flomax or other alpha-1 blockers, the recommendation from the FDA is that the ophthalmologist should be prepared for modifications during surgery if IFIS occurs.
Long-Acting Beta Agonists
The FDA recently requested that the manufacturers of the products Advair Diskus, Foradil Aerolizer, and Servent Diskus update their current product labels to reflect new warnings associated with these agents. The FDA has also requested a medication guide to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, sometimes resulting in death. These products all contain long-acting beta 2-adrenergic agonists (LABA), which are long-acting bronchodilator medications. These products often decrease the frequency of asthma episodes, but they may make asthma episodes more severe when they do occur. The FDA has requested that this information be placed in the updated product labeling. Patients will also receive a medication guide when a prescription for an LABA is filled or refilled.
To read additional information about this warning and FDA recommendations for your patients, please go to http://www.fda.gov/cder/drug/advisory/LABA.htm.
Avinza Labeling
Ligand Pharmaceuticals Inc., the manufacturer of Avinza, and the FDA recently notified health care professionals of a labeling revision for Avinza. This revision highlights and strengthens the warnings that patients taking Avinza should not drink alcohol or use medications that may contain alcohol.
For more information about this labeling update, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
Medication Errors
The FDA and AstraZeneca recently notified health care professionals about the potential for dispensing errors related to confusion between Toprol XL, an AstraZeneca product, and Topamax, an Ortho-McNeil Neurologics, Inc. product. The indications for Toprol XL include the treatment of hypertension, long-term treatment of angina pectoris, and treatment of heart failure NYHA Class II or III, while the indications for Topamax include epilepsy and migraine prophylaxis. There have also been reports regarding medication errors involving the Novartis Pharmaceuticals Corporation products Toprol XL and Tegretol or Tegretol-XR. Tegretol is indicated for the treatment of complex partial seizures, generalized tonic- clonic seizures, and trigeminal neuralgia. These medication errors may potentially lead to adverse effects.
For more information about these potential medication errors, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
Ortho Evra
The FDA recently alerted health care professionals and patients regarding revisions to the labeling of Ortho Evra, a transdermal birth control agent. This update includes a boldface warning about the higher estrogen exposure of women using the transdermal patch compared with women using a daily birth control pill containing 35 micrograms of estrogen. Ortho Evra usage may expose a woman to approximately 60 percent more estrogen than a birth control pill containing 35 micrograms of estrogen. Estrogen use has been associated with blood clots and other clotting problems. It remains unknown whether women using Ortho Evra have a higher risk of serious adverse events than women taking the oral birth control pills with 35 micrograms of estrogen.
For more information on this warning, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
Amevive Labeling
The FDA and Biogen Idec recently made a revision to the contraindications labeling for the medication Amevive, which is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The labeling update includes the information that Amevive should not be administered to patients infected with HIV. Because this medication reduces the CD4+ T lymphocyte counts, the disease progression may be accelerated or the potential for complications of the disease may be increased.
For more information on this warning, please refer to http://www.fda.gov/medwatch/safety/2005/safety05.htm.
October 2005
Cymbalta (duloxetine) Warning Issued
On October 18, 2005, Eli Lilly and the Food and Drug Administration notified health care professionals of a revision to the Precautions/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride). Cymbalta is indicated for the treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with pre-existing liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the “precaution” against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.
August 2005
Accutane iPledge Program
The FDA is initiating a strengthened risk-management program called iPledge for Accutane and generic isotretinoin prescriptions. Wholesalers, prescribers, pharmacies, and patients will be required to register as part of this updated program. Registering includes an agreement to accept specific responsibilities designed to minimize pregnancy exposures. The FDA has also approved changes to the existing warnings, patient information, and informed consent documents to assist with identifying and managing the risks of psychiatric symptoms and depression associated with isotretinoin therapy.
July 2005
New Labeling and Distribution Program for Iressa
The Federal Drug Administration (FDA) approved new labeling for Iressa that limits the indication to cancer patients who are currently benefiting or who have previously benefited from Iressa treatment. These changes resulted from two clinical trials that showed Iressa did not increase the survival benefit in patients with non-small-cell lung cancer.
For more information, visit the following websites:
www.fda.gov/cder/drug/advisory/iressa.htm
www.fda.gov/cder/drug/InfoSheets/HCP/gefitinibHCP.htm
Eli Lilly announces removal of four insulin products from the market
Due to declining use, Eli Lilly is discontinuing Humulin U Ultralente and Humulin L Lente and Regular Ilentin II and NHP Iletin II Pork Insulins. Based on current patient demand, Lilly anticipates that these products will be available through December 31, 2005.
Lilly recommends that health care providers consider switching patients currently using Humulin L, Humulin U, and NPH Iletin II Pork Insulin to NPH human insulin or a basal insulin analog. Providers should consider switching those patients taking Regular Iletin II Pork Insulin to regular human insulin or a rapid-acting insulin analog.
For more information, physicians can visit www.LillyConnect.com. Patients should be directed to www.lillydiabetes.com. Contact Lilly at 1-800-LillyRX (1-800-545-5979) with questions.
Sales of Palladone Suspended
Purdue Pharmaceuticals, the manufacturer of Palladone (hydromorphone HCl extended-release capsules), has suspended sales and marketing of Palladone because of the potential for serious adverse events if Palladone is taken with alcohol. Consuming alcohol while taking Palladone can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone.
Please follow this link for more information
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Palladone
June 2005
FDA Recalls Certain Children’s Tylenol Lots
The Federal Drug Administration (FDA) has announced a nationwide recall of all lots and flavors of Children's Tylenol Meltaways 80 mg, Children's Tylenol SoftChews 80 mg, and Junior Tylenol Meltaways 160 mg.
This recall stems from issues regarding the design of the blister package and information on the package that may be confusing and lead to improper dosing, including over dosage. The Institute for Safe Medication Practices (ISMP) has issued an alert describing this medication safety concern.
For more information, visit the following websites:
Warning Added to NSAIDs Label
The Federal Drug Administration (FDA) has requested that the labels of Celebrex and all non-steroidal anti-inflammatory drugs (NSAIDs) include a boxed warning that highlights the potential for increased cardiovascular events and serious gastrointestinal bleeding associated with the use of these drugs.
This warning includes prescription and over-the-counter medications including, but not limited to, celecoxib (Celebrex), ibuprofen (Motrin, Advil), naproxen (Alleve, Naprosyn), diclofenac (Voltaren, Cataflam), and ketoprofen (Orudis).
For more information, call 1-888-INFO-FDA (automated) or 301-827-4570.
Opioid Addiction Treatment Outlined
The FDA has approved two sublingual formulations of the Schedule III opioid partial agonist medication buprenorphine for the treatment of opioid addiction. These medications, Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone), are the only medications to have received such FDA approval.
Prescription use of buprenorphine in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence. Providers are limited to treating up to 30 patients at any one time.
To qualify for a waiver under the Drug Addiction Treatment Act of 2000 (DATA) a licensed physician (MD or DO) must meet any one or more of the following criteria:
- The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties
- The physician holds an addiction certification from the American Society of Addiction Medicine
- The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association
- The physician has, with respect to the treatment and management of opioid-addicted patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.
- The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug
- The physician has such other training or experience as the State medical licensing board (of the State in which the physician will provide maintenance or detoxification treatment) considers to demonstrate the ability of the physician to treat and manage opioid-addicted patientsThe physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opioid-addicted patients
For more information, visit the following websites:
March 2005
Abbott discontinuing sales of Cylert
Abbott Laboratories Inc., says it is halting sales of the attention deficit drug Cylert because of declining sales.
Abbot declined to comment on previous charges from a consumer group that the drug had caused 21 cases of liver failure, including 13 that were fatal or required transplants.
Generic companies sell versions of the drug under the name pemoline.
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