Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.
Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk).
Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
Source: http://www.fda.gov/medwatch/safety/2007/CellCept_dearhcpoct07.pdf
Tuesday, October 30, 2007
Friday, October 26, 2007
Intramuscular Methotrexate-Induced Aseptic Meningitis
A case of a 62-year-old male presenting on 3 separate occasions with symptoms consistent with aseptic meningitis: 2 requiring hospitalization and 1 noted during a subsequent ambulatory care visit, has been published in the latest issue of Annals of Pharmacotherapy.
Methotrexate-induced aseptic meningitis has been reported in the literature; however, in those cases, the effect occurred only when methotrexate was given via the intrathecal route. The Naranjo probability scale indicates a probable relationship between the development of the condition and the methotrexate use in this patient.
Source: The Annals of Pharmacotherapy 2007;41(11):1906-1911.
http://www.theannals.com/cgi/content/abstract/41/11/1906
Methotrexate-induced aseptic meningitis has been reported in the literature; however, in those cases, the effect occurred only when methotrexate was given via the intrathecal route. The Naranjo probability scale indicates a probable relationship between the development of the condition and the methotrexate use in this patient.
Source: The Annals of Pharmacotherapy 2007;41(11):1906-1911.
http://www.theannals.com/cgi/content/abstract/41/11/1906
Wednesday, October 24, 2007
FDA Advisory Committees Recommend Against Cough and Cold Medications in Children Under 6
Citing a lack of proven effectiveness and a need for clinical trials in children, the FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended the ingredients in cough and cold medications not be used in children younger than 6.
The agency convened a two-day meeting in response to a citizen petition requesting the FDA not allow the drugs to be marketed for children younger than 6. The petition was filed by the Baltimore City Health Department on behalf of several hospitals and universities. Although the petitioners’ request applies to children younger than 6, the agency told the committees any actions it takes could apply to children younger than 12.
The FDA is not required to accept advisory committee recommendations but usually does. Petitioners testifying to the committees argued, based on review of published studies, that cough and cold products intended for use in children have not been proven effective. Therefore, any adverse events associated with their use in the respective patient populations are not appropriate, and use of the drugs in children should be limited.The FDA agreed that the drugs have not been shown to be effective but said it was important to consider the studies were not well designed. If the agency were to act on the advisory committees’ recommendations, it would have to start the rulemaking process.
The panel voted unanimously that the products should not be used in children younger than 2 and voted 13-9 against use in those between the ages of 2 and 6. The committees did not recommend against use of the drugs in children between the ages of 6 and 12, with seven members voting to ban it and 15 not to. However, the members voted unanimously that cough and cold medicines have not been shown effective in children younger than 12.
Source: http://news.google.co.in/news?hl=en&ned=in&q=FDA
The agency convened a two-day meeting in response to a citizen petition requesting the FDA not allow the drugs to be marketed for children younger than 6. The petition was filed by the Baltimore City Health Department on behalf of several hospitals and universities. Although the petitioners’ request applies to children younger than 6, the agency told the committees any actions it takes could apply to children younger than 12.
The FDA is not required to accept advisory committee recommendations but usually does. Petitioners testifying to the committees argued, based on review of published studies, that cough and cold products intended for use in children have not been proven effective. Therefore, any adverse events associated with their use in the respective patient populations are not appropriate, and use of the drugs in children should be limited.The FDA agreed that the drugs have not been shown to be effective but said it was important to consider the studies were not well designed. If the agency were to act on the advisory committees’ recommendations, it would have to start the rulemaking process.
The panel voted unanimously that the products should not be used in children younger than 2 and voted 13-9 against use in those between the ages of 2 and 6. The committees did not recommend against use of the drugs in children between the ages of 6 and 12, with seven members voting to ban it and 15 not to. However, the members voted unanimously that cough and cold medicines have not been shown effective in children younger than 12.
Source: http://news.google.co.in/news?hl=en&ned=in&q=FDA
Monday, October 22, 2007
Sildenafil, Tadalafil and Vardenafil.
FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra (Sildenafil), Levitra (Vardenafil), Cialis (Tadalafil) for the treatment of erectile dysfunction, and Revatio (Sildenafil) for the treatment of pulmonary arterial hypertension.
In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors.
The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm
In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors.
The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm
Thursday, October 18, 2007
Acute Pancreatitis Associated with Exenatide
FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking exenatide, a drug used to treat adults with type 2 diabetes. An association between Exenatide and acute pancreatitis is suspected in some of these cases.
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Exenatide to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Exenatide should be discontinued. If pancreatitis is confirmed, Exenatide should not be restarted unless an alternative etiology is identified.
Source: http://www.fda.gov/cder/drug/infopage/exenatide/default.htm
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Exenatide to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Exenatide should be discontinued. If pancreatitis is confirmed, Exenatide should not be restarted unless an alternative etiology is identified.
Source: http://www.fda.gov/cder/drug/infopage/exenatide/default.htm
Wednesday, October 3, 2007
Atrial Fibrillation associated with Bisphosphonates
FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer. FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation.
In addition, as part of the data review for the recent approval of once-yearly Reclast (Zoledronic Acid) for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
Source: http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm
In addition, as part of the data review for the recent approval of once-yearly Reclast (Zoledronic Acid) for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
Source: http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm
Monday, October 1, 2007
FDA Takes Action To Stop Marketing Of Unapproved Hydrocodone Products
FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a coughsuppressant and to treat pain.
The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death,if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills andjudgment. The FDA has received reports of medication errors associated withformulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency isparticularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.
No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 yearsof age. Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31,2007.
Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007,and must cease further shipment in interstate commerce on or beforeMarch 31, 2008. Further legal action could be taken against those failing to meet these deadlines. There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult ahealthcare professional for detailed guidance on treatment options.
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Hydrocodone
The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death,if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills andjudgment. The FDA has received reports of medication errors associated withformulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. Most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency isparticularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.
No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 yearsof age. Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31,2007.
Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007,and must cease further shipment in interstate commerce on or beforeMarch 31, 2008. Further legal action could be taken against those failing to meet these deadlines. There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. Consumers should consult ahealthcare professional for detailed guidance on treatment options.
Source: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Hydrocodone
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