MedWatch Program Research Articles

Doxycycline and Intracranial Hypertension; Anorgasmia with a “Good”Antidepressant; Fluoroquinolones Should be Avoided in Myasthenia Gravis; Antipsychotics and Risk of Sudden Cardiac Death; Sotalol-Induced Depression; Methemoglobinemia Associated with Benzocaine Products; Allergic to Generics?; Call for ADR Reports

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's MEDWATCH program (800-FDA-1088). If you have reported an interesting preventable ADR to MEDWATCH, please consider sharing the account with our readers. In 2004, ISMP is celebrating the 10th anniversary of its incorporation as a nonprofit organization. The Institute represents more than 20 years of experience in helping health care practitioners keep patients safe, and continues to lead efforts to improve the medication use process.

Montelukast-Induced Urticaria; Acute Ischemic Colitis Caused by Anaphylactic Reaction; Pulmonary Edema Associated with a COX-2 Inhibitor; Hepatotoxicity with Citalopram; CNS Disturbances with Alendronate; Long QT Syndrome and QT Prolongation with Famotidine; Two Recommended Reviews

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's MEDWATCH program (800-FDA-1088). If you have reported an interesting preventable ADR to MEDWATCH, please consider sharing the account with our readers. In 2004, ISMP is celebrating the 10th anniversary of its incorporation as a nonprofit organization. The Institute represents more than 20 years of experience in helping health care practitioners keep patients safe, and continues to lead efforts to improve the medication use process.

Clarifying Adverse Drug Event Terminology; Thiazolidinedione-Induced Congestive Heart Failure; Riluzole-Induced Neutropenia; Possible Pancreatitis Linked to Quetiapine Use; Clopidogrel-Induced Thrombotic, Thrombocytopenic Purpura

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's MEDWATCH program (800-FDA-1088). If you have reported an interesting preventable ADR to MEDWATCH, please consider sharing the account with our readers. In 2004, ISMP is celebrating the 10th anniversary of its incorporation as a nonprofit organization. The Institute represents more than 20 years of experience in helping health care practitioners keep patients safe, and continues to lead efforts to improve the medication use process.

Montelukast-Induced Hepatitis; Dobutamine-Induced Eosinophilia; Ezetimibe and Statin-Associated Myopathy; Valproic Acid and Hypersensitivity Syndrome; Ribavirin-Induced Hemoglobinuria; Fingernail Clubbing and Discoloration Associated with Angiotensin II Receptor Blockers

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Cardiovascular implications of thiazolidinedione therapy.

The incidence of obesity and type 2 diabetes mellitus (DM2) in the United States has been increasing dramatically over the past 15 years, and is now at epidemic proportions. DM2 is the clinical manifestation of a long-term metabolic process that is initiated by cells' decreased sensitivity to the actions of insulin. Many outcome studies have identified DM2 as a strong and independent risk factor for the development of cardiovascular complications such as hypertension, arteriosclerosis, and heart failure. The goals of therapy in treating DM2 are to improve the long-term outlook for these patients. However, in selecting a therapeutic regimen for patients, clinicians should be aware that potentially severe adverse events may occur at a rate not previously identified in phase 3 studies. Certain therapies used to treat DM2, by effectively increasing the sensitivity of insulin, have also been reported to cause adverse effects, which can precipitate symptomatic heart failure. The purpose of this column is to discuss the therapeutic options available for treating patients with DM2, the potential pathophysiology of the adverse events of symptomatic heart failure, encouragement of use of the US Food and Drug Administration MedWatch program for reporting adverse events associated with medication therapy, and review of newer treatment guidelines for use of insulin-sensitizing agents in patients with chronic heart failure.

Myopathy Due to Inhaled Corticosteroid TIA Associated with SSRI Tenofovir Nephrotoxicity Linezolid-Induced Neuropathy Adverse Events Related to Transferring between Acute Care and Long-Term Care Facilities ADRs with Anthelmintics

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Incidence, Cause, and Severity of Anaphylaxis; Quinine and Quinidine Thrombocytopenia; Ephedra-Associated Cardiomyopathy; Seizures Caused by Hydrocortisone; Paroxetine-Induced Hyponatremia; Heparin-Induced Hyponatremia

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Enoxapirin-Induced Thrombocytopenia in a Child; Warfarin-Induced Skin Necrosis and Gangrene during HIT; Possible Seizure Due to Fluoroquinolone; Amifostine-Induced Fever; Neuroleptic Malignant Syndrome with Paroxetine and Olanzapine

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Cognitive Impairment with Statins?; Premature Ejaculation after Discontinuing an SSRI; Adverse Reactions to Trimethoprim/Sulfamethoxazole in Patient with AIDS; Neutropenia Associated with Piperacillin-Tazobactam; Hypertensive Crisis with Antidepressant Imatinib-Associated Pulmonary Alveolar Proteinosis

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Small Vessel Vasculitis: A Complication of Tumor Necrosis Factor-α Blocking Agents

Small vessel vasculitis (SVV) of the skin usually manifests histologically as leukocytoclastic vasculitis (LCV). Vasculitis may be caused by drugs or other ingestants and may complicate a variety of disorders associated with immune-complex formation. Tumor necrosis factor-α (TNF-α) antagonists are relatively safe agents that are approved for treating many diseases. These authors describe complications of TNF-α therapy reported to the Food and Drug Administration's MedWatch program, a …

Acute Delirium after Hepatitis a Vaccine Ocular Side Effects with Topiramate Omeprazole-Induced Intractable Cough Levetiracetam Behavioral Side Effects: Another Large Review Atorvastatin-Induced Polyneuropathy Prolonged Thrombocytopenia in a Patient Using Isotretinoin

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Retroperitoneal Hematoma Caused by Low-Molecular-Weight Heparin Retroperitoneal Hemorrhage Due to Warfarin Thromboembolism and Clozapine Therapy Neutropenia Caused by Valproic Acid Amoxicillin Crystalluria as a Cause of Acute Renal Failure Facial Hyperpigmentation Associated with Imipramine Readers Address Psychiatric Problems Related to Opiates

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Shock-Like Sensations Associated with Antidepressant Withdrawal Acute Tumor Lysis Syndrome Caused by Hydroxyurea Zolpidem-Induced Visual Hallucinations Tooth Discoloration with Linezolid Sleepwalking Caused by SSRI ADR-Related Reports from the Archives of Internal Medicine

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Psychotic Behavior Associated with Opioids in Elderly Patients Montelukast-Induced Hepatotoxicity Neuroleptic Malignant Syndrome and Low-Dose Olanzapine Visual Hallucinations with Zonisamide Thrombotic Complications Associated with IV Immunoglobulin Therapy

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Case reports of heart failure after therapy with a tumor necrosis factor antagonist.

Etanercept and infliximab are U.S. Food and Drug Administration-approved tumor necrosis factor (TNF) antagonists. To describe adverse event reports of heart failure after TNF antagonist therapy. Case series. The U.S. Food and Drug Administration's MedWatch program. 47 patients who developed new or worsening heart failure during TNF antagonist therapy. Clinical and laboratory reports. After TNF antagonist therapy, 38 patients developed new-onset heart failure and 9 patients experienced heart failure exacerbation. Of the 38 patients with new-onset heart failure, 19 (50%) had no identifiable risk factors. Ten patients younger than 50 years of age developed new-onset heart failure after receiving TNF antagonists. After TNF antagonist therapy was discontinued and heart failure therapy was started in these 10 patients, 3 had complete resolution of heart failure, 6 improved, and 1 died. In a fraction of patients, TNF antagonists might induce new-onset heart failure or exacerbate existing disease.

Another Major Study on Adverse Events in the Ambulatory Setting Hepatotoxicity Caused by Angiotensin II Receptor Blockers Interferon Alfa Therapy and Psychosis Priapism with an Atypical Antipsychotic Update on Drug-Induced Thrombocytopenia

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Adverse Drug Reactions outside the Hospital Two Separate Adverse Events Caused by Clopidogrel Hepatic Failure Due to Propylthiouracil Newer Antipsychotic Agent Reported to Cause Priapism

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance

ContextEphedra and ephedrine sometimes are used for weight loss or enhanced athletic performance, but the efficacy and safety of these compounds are uncertain.ObjectiveTo assess the efficacy and safety of ephedra and ephedrine used for weight loss and enhanced athletic performance.Data SourcesWe searched 9 databases using the terms ephedra, ephedrine, adverse effect, side effect, efficacy, effective, and toxic. We included unpublished trials and non–English-language documents. Adverse events reported to the US Food and Drug Administration MedWatch program were assessed.Study SelectionEligible studies were controlled trials of ephedra or ephedrine used for weight loss or athletic performance and case reports of adverse events associated with such use. Eligible studies for weight loss were human studies with at least 8 weeks of follow-up; and for athletic performance, those having no minimum follow-up. Eligible case reports documented that ephedra or ephedrine was consumed within 24 hours prior to an adverse event or that ephedrine or an associated product was found in blood or urine, and that other potential causes had been excluded. Of the 530 articles screened, 52 controlled trials and 65 case reports were included in the adverse events analysis. Of more than 18 000 other case reports screened, 284 underwent detailed review.Data ExtractionTwo reviewers independently identified trials of efficacy and safety of ephedra and ephedrine on weight loss or athletic performance; disagreements were resolved by consensus. Case reports were reviewed with explicit and implicit methods.Data SynthesisNo weight loss trials assessed duration of treatment greater than 6 months. Pooled results for trials comparing placebo with ephedrine (n = 5), ephedrine and caffeine (n = 12), ephedra (n = 1), and ephedra and herbs containing caffeine (n = 4) yielded estimates of weight loss (more than placebo) of 0.6 (95% confidence interval, 0.2-1.0), 1.0 (0.7-1.3), 0.8 (0.4-1.2), and 1.0 (0.6-1.3) kg/mo, respectively. Sensitivity analyses did not substantially alter the latter 3 results. No trials of ephedra and athletic performance were found; 7 trials of ephedrine were too heterogeneous to synthesize. Safety data from 50 trials yielded estimates of 2.2- to 3.6-fold increases in odds of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations. Data are insufficient to draw conclusions about adverse events occurring at a rate less than 1.0 per thousand. The majority of case reports are insufficiently documented to allow meaningful assessment.ConclusionsEphedrine and ephedra promote modest short-term weight loss (≈0.9 kg/mo more than placebo) in clinical trials. There are no data regarding long-term weight loss, and evidence to support use of ephedra for athletic performance is insufficient. Use of ephedra or ephedrine and caffeine is associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations.

Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.

Ephedra and ephedrine sometimes are used for weight loss or enhanced athletic performance, but the efficacy and safety of these compounds are uncertain. To assess the efficacy and safety of ephedra and ephedrine used for weight loss and enhanced athletic performance. We searched 9 databases using the terms ephedra, ephedrine, adverse effect, side effect, efficacy, effective, and toxic. We included unpublished trials and non-English-language documents. Adverse events reported to the US Food and Drug Administration MedWatch program were assessed. Eligible studies were controlled trials of ephedra or ephedrine used for weight loss or athletic performance and case reports of adverse events associated with such use. Eligible studies for weight loss were human studies with at least 8 weeks of follow-up; and for athletic performance, those having no minimum follow-up. Eligible case reports documented that ephedra or ephedrine was consumed within 24 hours prior to an adverse event or that ephedrine or an associated product was found in blood or urine, and that other potential causes had been excluded. Of the 530 articles screened, 52 controlled trials and 65 case reports were included in the adverse events analysis. Of more than 18 000 other case reports screened, 284 underwent detailed review. Two reviewers independently identified trials of efficacy and safety of ephedra and ephedrine on weight loss or athletic performance; disagreements were resolved by consensus. Case reports were reviewed with explicit and implicit methods. No weight loss trials assessed duration of treatment greater than 6 months. Pooled results for trials comparing placebo with ephedrine (n = 5), ephedrine and caffeine (n = 12), ephedra (n = 1), and ephedra and herbs containing caffeine (n = 4) yielded estimates of weight loss (more than placebo) of 0.6 (95% confidence interval, 0.2-1.0), 1.0 (0.7-1.3), 0.8 (0.4-1.2), and 1.0 (0.6-1.3) kg/mo, respectively. Sensitivity analyses did not substantially alter the latter 3 results. No trials of ephedra and athletic performance were found; 7 trials of ephedrine were too heterogeneous to synthesize. Safety data from 50 trials yielded estimates of 2.2- to 3.6-fold increases in odds of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations. Data are insufficient to draw conclusions about adverse events occurring at a rate less than 1.0 per thousand. The majority of case reports are insufficiently documented to allow meaningful assessment. Ephedrine and ephedra promote modest short-term weight loss (approximately 0.9 kg/mo more than placebo) in clinical trials. There are no data regarding long-term weight loss, and evidence to support use of ephedra for athletic performance is insufficient. Use of ephedra or ephedrine and caffeine is associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations.

Panhypogammaglobulinemia Associated with Phenytoin Therapy;Status Epilepticus after Abrupt Withdrawal of High-Dose Gabapentin Therapy;Thalidomide-Induced Neuropathy;Ergot Toxicity as a Result of Over-the-Counter Drug Use;Systemic Absorption of Ophthalmic Medication Leads to Child's Overdose;Risperidone-Induced Hyperprolactinemia

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.