Withdrawal of drugs
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Drug Withdrawal: Patterns, Causes, and Management
Post-Marketing Drug Withdrawal Due to Adverse Reactions
Patterns of Drug Withdrawal
The withdrawal of medicinal products post-marketing is a significant issue in pharmacovigilance. A systematic review identified 462 medicinal products withdrawn between 1953 and 2013, primarily due to adverse drug reactions (ADRs) such as hepatotoxicity. The evidence supporting these withdrawals was often anecdotal, with 72% of cases relying on such reports. Similarly, another review found that out of 353 medicinal products withdrawn worldwide, only 40 were withdrawn globally, with hepatic, cardiac, and nervous system toxicity accounting for over 60% of these withdrawals. The median interval between the first reported ADR and the first withdrawal was six years, indicating a lag in response time .
Inconsistencies in Withdrawal Procedures
There are notable discrepancies in the patterns of drug withdrawals across different countries. For instance, withdrawal was significantly less likely in Africa compared to other continents. This inconsistency highlights the need for greater coordination among drug regulatory authorities and increased transparency in reporting suspected ADRs . A uniform method for establishing worldwide withdrawal procedures when ADRs are suspected could facilitate more timely and consistent global withdrawals.
Management of Drug Withdrawal Syndromes
Withdrawal from Psychotropic Medications
Withdrawal syndromes are common following the discontinuation of psychotropic medications, including antidepressants, antipsychotics, and benzodiazepines. These syndromes can include new withdrawal symptoms, rebound symptoms, and persistent post-withdrawal disorders. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are particularly associated with persistent post-withdrawal disorders and severe symptoms. The management of these syndromes often involves reintroducing the original medication or switching to another, although this may sometimes aggravate the condition.
Behavioral and Pharmacologic Withdrawal
Withdrawal from addictive drugs such as alcohol, opioids, and stimulants involves complex changes over time, including negative affect and urges that are highly predictive of relapse. The negative emotional state during withdrawal, termed hyperkatifeia, is a major motivational factor driving compulsive drug-seeking behavior. Effective management strategies include both pharmacologic interventions and behavioral therapies to mitigate these symptoms and reduce the risk of relapse .
Conclusion
The withdrawal of drugs post-marketing due to adverse reactions is a complex and inconsistent process that varies significantly across different regions. Improved coordination among regulatory authorities and standardized global procedures are essential for timely and effective drug withdrawals. Additionally, managing withdrawal syndromes, particularly from psychotropic and addictive drugs, requires a comprehensive approach that includes both pharmacologic and behavioral strategies to address the multifaceted nature of withdrawal symptoms and prevent relapse.
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