Antituberculosis Drug-Induced Fixed Drug Eruption: A Case Report
Jitendra H Vaghela1, Vivek Nimbark2, Manish Barvaliya3
1Department of Pharmacology, Government Medical College, 1st Floor, Bhavnagar, Gujarat, 364001, India. drjitendravaghela@gmail.com.
Drug Safety - Case Reports
|May 23, 2018
Summary
Fixed-dose combination (FDC) antituberculosis drugs caused a fixed drug eruption (FDE) in a patient with a history of drug allergy. FDCs should be avoided in such patients to prevent complex adverse drug reactions.
Area of Science:
- Pharmacology
- Dermatology
- Infectious Diseases
Background:
- Fixed drug eruption (FDE) is a type of adverse drug reaction characterized by recurrent skin lesions at the same site upon re-exposure to a causative agent.
- Antituberculosis therapy often involves fixed-dose combinations (FDCs) for patient convenience and adherence.
- Patients with a history of drug allergies may be at increased risk for adverse drug reactions.
Purpose of the Study:
- To report a case of fixed drug eruption caused by a fixed-dose combination of antituberculosis drugs.
- To highlight the potential risks associated with using FDCs in patients with a history of drug allergies.
- To emphasize the importance of identifying individual drug components in FDCs for accurate diagnosis and management of adverse reactions.
Main Methods:
- A case study of a 40-year-old male patient diagnosed with pulmonary tuberculosis.
- The patient developed a fixed drug eruption after initiating treatment with tablet Forecox®, an FDC containing rifampicin, isoniazid, pyrazinamide, and ethambutol.
- Causality assessment was performed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and the Naranjo scale. Severity was assessed using the Modified Hartwig and Siegel scale.
Main Results:
- The patient developed FDE after the third dose of the FDC antituberculosis medication.
- The reaction resolved within 15 days after discontinuation of the FDC and appropriate treatment for FDE.
- Causality assessment indicated a possible and probable association between the FDC and the FDE, respectively. The reaction was classified as moderately severe.
Conclusions:
- Fixed-dose combinations of antituberculosis drugs can cause fixed drug eruptions, particularly in patients with a history of drug allergies.
- The use of FDCs complicates the identification of the specific culprit drug in cases of adverse drug reactions.
- It is recommended to avoid FDCs in patients with a history of drug allergies to prevent complex allergic reactions and facilitate accurate diagnosis.
Related Concept Videos
01:25Pharmacokinetics: Drug–Drug Interactions
462
Drug interactions occur when the pharmacological effect of one drug is altered by another substance, either enhancing or diminishing its activity. The drug whose activity is altered is known as the object drug, and the substance causing the alteration is called the agent drug or the precipitant. The net effects of these interactions are mostly undesirable, leading to decreased effectiveness or increased adverse effects. In rare cases, interactions can be beneficial, such as the enhanced...
462
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
163
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
163
01:26FDA Approved Drugs: Changes to Approved Drugs
273
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
273
01:26Pharmacokinetics: Drug–Food and Drug–Viral Interactions
262
A drug interaction occurs when the concurrent use of another drug, food, or an external substance alters the pharmacological activity of a drug. This interaction can modify the action of the original drug, affecting its effectiveness and safety.Drug–food interactions are significant as they impact drug absorption, metabolism, and excretion. For example, grapefruit juice is a well-known disruptor of drug metabolism. It inhibits the cytochrome P450 3A4 enzyme, crucial for the metabolism of...
262
01:27Factors Influencing Drug Absorption: Drug Dissolution
1.2K
The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
1.2K
01:18Factors Affecting Protein-Drug Binding: Drug-Related Factors
490
Drug binding to proteins is a complex phenomenon influenced by various drug-related factors, each playing a significant role in the interaction between drugs and proteins within the body.
One crucial factor in drug-protein binding is the drug's lipophilicity or its affinity for fat. More lipophilic drugs tend to have higher binding extents. For example, highly lipophilic drugs like cloxacillin exhibit substantial protein binding, with as much as 95% of the drug binding to proteins. In...
One crucial factor in drug-protein binding is the drug's lipophilicity or its affinity for fat. More lipophilic drugs tend to have higher binding extents. For example, highly lipophilic drugs like cloxacillin exhibit substantial protein binding, with as much as 95% of the drug binding to proteins. In...
490