A federal drug advisory committee voted overwhelmingly on Monday to recommend that the diabetes drug Avandia remain on the market, even after finding that it raised the risks of heart attacks.
Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.
Source: http://www.nytimes.com/2007/07/31/health/31drug.html?hp
Tuesday, July 31, 2007
Saturday, July 28, 2007
Bisphosphonate induced Osteonecrosis of the Jaw [BONJ]
Bisphosphonate associated osteonecrosis of the jaws (BONJ) has been well documented recently in relation to intravenous preparations of the drug. These are most commonly used as part of the management of hypercalcaemia of malignancy and metastatic bone disease but BONJ can also occur in association with oral bisphosphonate use. The oral preparations can also be prescribed in the management of metastatic bone disease but are more commonly used for the prevention and treatment of osteoporosis.
Three case reports have been published in the British Dental Journal in which alendronate, risedronate and ibandronate have been associated with osteonecrosis of the jaws.The authors conclude, in agreement with other published authors, that prevention and early detection could be improved to reduce the occurrence and severity of this condition. However when BONJ is diagnosed, the early application of a closely monitored conservative regimen, with consideration given to discontinuation of the bisphosphonate, may give the best chance of containing or resolving the condition.
Source: British Dental Journal 2007;203:93-97.
http://www.nature.com/bdj/journal/v203/n2/full/bdj.2007.636.html
Three case reports have been published in the British Dental Journal in which alendronate, risedronate and ibandronate have been associated with osteonecrosis of the jaws.The authors conclude, in agreement with other published authors, that prevention and early detection could be improved to reduce the occurrence and severity of this condition. However when BONJ is diagnosed, the early application of a closely monitored conservative regimen, with consideration given to discontinuation of the bisphosphonate, may give the best chance of containing or resolving the condition.
Source: British Dental Journal 2007;203:93-97.
http://www.nature.com/bdj/journal/v203/n2/full/bdj.2007.636.html
Friday, July 27, 2007
Antidepressant induced Liver injury
Antidepressant-induced liver injury described in published cases were of the idiopathic type and, by definition, cannot be predicted based on dose or specific risk factors. Paroxetine had the largest number of cases within the selective serotonin-reuptake inhibitor class. Nefazodone, a serotonin-norepinephrine reuptake inhibitor, appeared to have the most serious cases and is the only antidepressant agent that carries a Food and Drug Administration Black Box Warning regarding hepatotoxicity. The tricyclic antidepressants and monoamine oxidase inhibitors are capable of producing hepatotoxicity, but fewer cases with these agents have been reported in the past 15 years, possibly due to a decline in their use. Causality has not been well established in all reports due to the concurrent use of other drugs and/or underlying liver disease.
Most antidepressant agents have the potential to produce idiopathic liver injury. There is no way to prevent idiopathic DILI, but the severity of the reaction may be minimized with prompt recognition and early withdrawal of the agent. The clinician must be careful to provide ongoing therapy of the underlying depressive disorder and be aware of possible drug discontinuation syndromes should potential hepatotoxicity be suspected.
Source: The Annals of Pharmacotherapy 2007;41(7):1201-1211.
http://www.theannals.com/cgi/content/abstract/41/7/1201
Most antidepressant agents have the potential to produce idiopathic liver injury. There is no way to prevent idiopathic DILI, but the severity of the reaction may be minimized with prompt recognition and early withdrawal of the agent. The clinician must be careful to provide ongoing therapy of the underlying depressive disorder and be aware of possible drug discontinuation syndromes should potential hepatotoxicity be suspected.
Source: The Annals of Pharmacotherapy 2007;41(7):1201-1211.
http://www.theannals.com/cgi/content/abstract/41/7/1201
Tuesday, July 24, 2007
Rabeprazole induced Neuropsychiatric Symptoms
A case of a patient who developed marked anxiety associated with episodes of panic attacks after starting rabeprazole therapy has been reported in The Annals of Pharmacotherapy.
An otherwise healthy 55-year-old woman was prescribed rabeprazole 20 mg/day administered in the morning for persistent symptoms of dyspepsia. Ten days later, she presented with a 7 day history of marked anxiety associated with panic attacks, night terror (pavor nocturnus), episodic mental confusion, and attention deficit. Within 2 days of discontinuing rabeprazole, the patient recovered completely from the neuropsychiatric manifestations. Subsequent esomeprazole therapy did not cause psychiatric symptoms.
Source: http://www.theannals.com/cgi/content/abstract/41/7/1315
An otherwise healthy 55-year-old woman was prescribed rabeprazole 20 mg/day administered in the morning for persistent symptoms of dyspepsia. Ten days later, she presented with a 7 day history of marked anxiety associated with panic attacks, night terror (pavor nocturnus), episodic mental confusion, and attention deficit. Within 2 days of discontinuing rabeprazole, the patient recovered completely from the neuropsychiatric manifestations. Subsequent esomeprazole therapy did not cause psychiatric symptoms.
Source: http://www.theannals.com/cgi/content/abstract/41/7/1315
Elevation of LDL cholesterol concentration with Over the Counter Fish oil preparation
A case of elevated low-density lipoprotein cholesterol (LDL-C) concentration in a patient taking fish oil supplements for hypertriglyceridemia has been reported in the Annals of Pharmacotherapy.
A 63-year-old white woman had been taking 2.7 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily in 9 g of over-the-counter (OTC) fish oil capsules for triglyceride lowering. Prior to the adverse event, she had baseline fasting triglyceride (TG) and LDL-C concentrations of 278 mg/dL and 106 mg/dL, respectively. After 6 weeks of treatment with fish oil, fasting TG levels decreased by 47.5% (-132 mg/dL) and the LDL-C increased by 75% (+80 mg/dL). Discontinuation of therapy for 6 weeks resulted in TG returning to high concentrations (334 mg/dL; +56 mg/dL change from baseline) and LDL-C decreasing toward baseline (143 mg/dL; +37 mg/dL change from baseline).
This case documents a much higher LDL-C elevation associated with OTC fish oil supplementation than has been previously identified in the literature. Healthcare providers should be advised that LDL-C levels may increase with use of OTC fish oil and should monitor patients periodically for such elevations. The significance of this increase on clinical outcomes is not known.
Source: http://www.theannals.com/cgi/content/abstract/41/7/1296
A 63-year-old white woman had been taking 2.7 g of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily in 9 g of over-the-counter (OTC) fish oil capsules for triglyceride lowering. Prior to the adverse event, she had baseline fasting triglyceride (TG) and LDL-C concentrations of 278 mg/dL and 106 mg/dL, respectively. After 6 weeks of treatment with fish oil, fasting TG levels decreased by 47.5% (-132 mg/dL) and the LDL-C increased by 75% (+80 mg/dL). Discontinuation of therapy for 6 weeks resulted in TG returning to high concentrations (334 mg/dL; +56 mg/dL change from baseline) and LDL-C decreasing toward baseline (143 mg/dL; +37 mg/dL change from baseline).
This case documents a much higher LDL-C elevation associated with OTC fish oil supplementation than has been previously identified in the literature. Healthcare providers should be advised that LDL-C levels may increase with use of OTC fish oil and should monitor patients periodically for such elevations. The significance of this increase on clinical outcomes is not known.
Source: http://www.theannals.com/cgi/content/abstract/41/7/1296
Monday, July 9, 2007
China stops sale of Methotrexate
China's drug safety agency has suspended sales of Methotrexate, a drug used to treat acute leukemia and rheumatoid arthritis.
Sales of methotrexate produced by Shanghai Hualian Pharmaceutical Co. Ltd. have been suspended because it caused an adverse reaction in several child leukemia patients in three hospitals in Shanghai and the southern province of Guangxi.
Some children felt pain in their legs while others experienced difficulty in walking after being injected with methotrexate numbered 070403A and 070403B.
Source: Reuters
http://www.reuters.com/article/healthNews/idUSPEK1476920070707
Sales of methotrexate produced by Shanghai Hualian Pharmaceutical Co. Ltd. have been suspended because it caused an adverse reaction in several child leukemia patients in three hospitals in Shanghai and the southern province of Guangxi.
Some children felt pain in their legs while others experienced difficulty in walking after being injected with methotrexate numbered 070403A and 070403B.
Source: Reuters
http://www.reuters.com/article/healthNews/idUSPEK1476920070707
Friday, July 6, 2007
Ceftriaxone Sodium
Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.
Source: FDA MedWatch July 5th 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin
Source: FDA MedWatch July 5th 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin
Wednesday, July 4, 2007
Unusual side effects with Acamprosate
A case report of a subject reporting with Extra Pyramidal Symptoms after adminstration of Acamprosate for treatment of Alcohol dependence has been reported.
Source: Indian J Psychiatry 2007;49:143.
http://www.indianjpsychiatry.org/article.asp?issn=0019-5545;year=2007;volume=49;issue=2;spage=143;epage=143;aulast=Sidana
Source: Indian J Psychiatry 2007;49:143.
http://www.indianjpsychiatry.org/article.asp?issn=0019-5545;year=2007;volume=49;issue=2;spage=143;epage=143;aulast=Sidana
Escitalopram induced Mania
A report of a case of recurrent depression with hypertension, ischemic heart disease and diabetes mellitus which switched to mania while on escitalopram. Escitalopram, one of the newer selective serotonin reuptake inhibitors (SSRIs), is considered to have fewer adverse effects and a lower propensity for drug interactions. However, escitalopram may induce mania at a maximum dose of 20 mg especially when given with Alprazolam which is known to boost efficacy of SSRIs.
Source: Indian J Psychiatry 2007;49:121-122.
http://www.indianjpsychiatry.org/article.asp?issn=0019-5545;year=2007;volume=49;issue=2;spage=121;epage=122;aulast=Parker
Source: Indian J Psychiatry 2007;49:121-122.
http://www.indianjpsychiatry.org/article.asp?issn=0019-5545;year=2007;volume=49;issue=2;spage=121;epage=122;aulast=Parker
Tuesday, July 3, 2007
Sanofi-Aventis Withdraws New Drug Application for Rimonabant
Sanofi-aventis announced it would withdraw its new drug application for Zimulti (Rimonabant) after an FDA advisory committee recommended against approving the drug over concerns it increased the risk of suicide.
The agency’s Endocrinological and Metabolic Drugs Advisory Committee voted unanimously that available safety data was insufficient to evaluate Zimulti’s (rimonabant) risk profile. The committee held the meeting over concerns of potential safety signals for psychiatric adverse events and suicidality.
Sanofi-aventis also said it plans to submit an update of rimonabant’s safety data to the European Medicine’s Agency (EMEA) Committee for Medicinal Products for Human Use. The agency announced it will review data on psychiatric events as part of its continuous monitoring of the drug’s safety. The EMEA announced it would re-examine the drug after the FDA advisory committee voted against its approval.
Source: American College of Clinical Pharmacology eNews group dated 3rd July 2007.
The agency’s Endocrinological and Metabolic Drugs Advisory Committee voted unanimously that available safety data was insufficient to evaluate Zimulti’s (rimonabant) risk profile. The committee held the meeting over concerns of potential safety signals for psychiatric adverse events and suicidality.
Sanofi-aventis also said it plans to submit an update of rimonabant’s safety data to the European Medicine’s Agency (EMEA) Committee for Medicinal Products for Human Use. The agency announced it will review data on psychiatric events as part of its continuous monitoring of the drug’s safety. The EMEA announced it would re-examine the drug after the FDA advisory committee voted against its approval.
Source: American College of Clinical Pharmacology eNews group dated 3rd July 2007.
Piroxicam
The European Medicines Agency (EMEA) has recommended restrictions on the use of piroxicam containing medicinal products because of the risk of gastrointestinal side effects and serious skin reactions.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions. Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. However it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions.
Prescription of piroxicam should always be initiated by a physician experienced in the treatment of patients with inflammatory or degenerative rheumatic diseases and treatment should be used in the lowest dose (no more than 20 mg per day) and for the shortest duration possible. In any case, the treatment should be reviewed after the first 14 days of starting.
Source: EMEA Press release: http://www.emea.europa.eu/pdfs/human/press/pr/26514407en.pdf
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions. Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. However it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions.
Prescription of piroxicam should always be initiated by a physician experienced in the treatment of patients with inflammatory or degenerative rheumatic diseases and treatment should be used in the lowest dose (no more than 20 mg per day) and for the shortest duration possible. In any case, the treatment should be reviewed after the first 14 days of starting.
Source: EMEA Press release: http://www.emea.europa.eu/pdfs/human/press/pr/26514407en.pdf
Omalizumab
Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for Xolair (Omalizumab) was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for Xolair is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, Xolair should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each Xolair injection.
Source: FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
Source: FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
Sunday, July 1, 2007
Hypopigmentation associated with Imatinib Mesylate
Three cases of hypopigmentation in patients of CML (Chronic Myelogenous Leukemia) being treated with Imatinib have been reported in Journal of Association of Physicians of India JAPI.
Source and Detailed Report: JAPI 2007;55:527.
http://www.japi.org/july2007/Corr1.pdf
Source and Detailed Report: JAPI 2007;55:527.
http://www.japi.org/july2007/Corr1.pdf
Colistimethate
FDA notified healthcare professionals and cystic fibrosis patients that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF). Colistimethate is FDA approved for intravenous or intramuscular injection for the treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli, particularly sensitive strains of Pseudomonas aeruginosa which are a significant problem for patients with CF and for patients with neutropenia, and/or immune system compromise. The product is not FDA approved for use as a liquid to be inhaled via nebulizer. In this case, the drug was prepared by a pharmacy and dispensed as prescribed in premixed unit dose ready-to-use vials. Once Colistimethate is mixed into a liquid form, the product breaks down into other chemicals that can damage lung tissue.
Healthcare professionals who choose to prescribe Colistimethate to treat patients with CF should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of the product. Patients should discard any unused pre-mixed liquid forms of Colistimethate.
Source: FDA Medwatch
http://www.fda.gov/cder/drug/InfoSheets/HCP/colistimethateHCP.htm
Healthcare professionals who choose to prescribe Colistimethate to treat patients with CF should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of the product. Patients should discard any unused pre-mixed liquid forms of Colistimethate.
Source: FDA Medwatch
http://www.fda.gov/cder/drug/InfoSheets/HCP/colistimethateHCP.htm
Propofol
FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation.
To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.
Source: FDA Medwatch
http://www.fda.gov/cder/drug/infopage/propofol/default.htm
To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.
Source: FDA Medwatch
http://www.fda.gov/cder/drug/infopage/propofol/default.htm
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