Name: Mohammed Dlshad Nooralddin
Stage: 5th grade
Pharmacy department
All healthcare sector workers, especially pharmacists, should stay updated on the latest advancements in medications and safety information. Pharmacists play a crucial role as the first point of contact for patients, guiding drug usage, risks, and benefits. With this in mind, here are some significant updates across the pharmaceutical industry, including new drug approvals, newly discovered side effects, surprising drug facts, and recent market withdrawals.
- Newly approved Drugs
Advancements in medicine continue to bring new treatment options to patients. Recent FDA-approved drugs include innovative therapies for pain management and bacterial infections, these new treatments offer hope for improved patient outcomes and better quality of life.
- Suzetrigin (Journavx) 50 mg is a first‐in‐class, non‐opioid analgesic approved on January 30, 2025, for the treatment of moderate to severe pain, it exerts its effect by inhibiting NaV1.8 sodium channels, which are voltage-gated channels found predominantly in peripheral nociceptors that transmit pain signals. The treatment regimen begins with an initial oral dose of 100 mg, administered at least 1 hour before a meal or 2 hours after eating, after 12 hours, the dose is reduced to 50 mg, followed by a maintenance dose of 50 mg every 12 hours, this dosing schedule should not be continued for more than 14 days and dosage adjustments may be necessary for patients with moderate hepatic impairment. Common side effects include muscle pain and itching. If a dose is missed, it should be taken as soon as possible unless the next scheduled dose is due within 6 hours—in which case, the missed dose should be skipped to resume the regular dosing schedule.
- Aztreonam/avibactam (Emblaveo) is a novel, fixed‐dose, intravenous antibiotic combination approved by the U.S. FDA on February 7, 2025, for treating complicated intra‐abdominal infections in adults with limited or no alternative treatment options. Represents a critical advancement in the fight against antimicrobial resistance among Gram‐negative bacteria, offering a new treatment option for patients with few or no alternatives available. It is used in combination with metronidazole and targets serious infections caused by Gram‐negative bacteria such as Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Emblaveo works by combining two complementary agents: aztreonam, a monobactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), and avibactam, a beta-lactamase inhibitor that protects aztreonam from degradation by enzymes including metallo-β-lactamases and serine β-lactamases that would otherwise render it ineffective, this synergy restores the antibacterial activity against pathogens that have developed resistance to many other antibiotics. The drug is administered by intravenous infusion over 3 hours. For adults with normal renal function, the recommended regimen typically consists of a loading dose of 2 g aztreonam/0.67 g avibactam, followed by maintenance doses of 1.5 g aztreonam/0.5 g avibactam every 6 hours. The duration of therapy is generally 5 to 14 days, depending on the severity and site of infection. Dosage adjustments are necessary for patients with renal impairment, and the drug should not be used in individuals with a known hypersensitivity to beta‐lactam antibiotics. Common adverse effects reported with Emblaveo include elevations in liver enzymes, anemia, diarrhea, hypokalemia, and fever.
- Newly discovered side effects in existing Drugs
Ongoing research has uncovered unexpected side effects in widely used drugs. These findings emphasize the importance of monitoring patients for adverse reactions and updating prescribing practices to ensure patient safety.
- Fluoroquinolone antibiotics (ex., Ciprofloxacin, etc.) used to treat bacterial infections, have been associated with an increased risk of psychiatric side effects, such as depression, psychosis, and suicidal ideation or behavior.
- Clozapine and olanzapine, typically classified as second-generation (atypical) antipsychotics, have been associated with agranulocytosis, a severe and potentially dangerous drop in white blood cell count. Consequently, it is recommended that WBC levels are regularly monitored during treatment.
- Astonishing Drug facts you might not know
Certain drugs have unique properties that may not be widely known but have critical implications, for example
Finasteride: commonly prescribed for hair loss and prostate enlargement, can cause severe teratogenic effects if pregnant women come into contact with crushed or broken tablets. Even minimal exposure can interfere with the normal development of male fetuses, leading to congenital disabilities.
- Thalidomide: was once prescribed to alleviate morning sickness in pregnant women, but its severe teratogenic effects, which led to serious congenital disabilities, resulted in its withdrawal from the market. It has since been reapproved for specific cancer treatments under strict conditions.
III. During pregnancy, it’s crucial to monitor vitamin A intake to support fetal development while avoiding potential risks. The recommended daily allowance for pregnant women is 770 micrograms of retinol activity equivalents, with a tolerable upper intake level of 3,000 mcg RAE per day. Exceeding this UL can increase the risk of congenital disabilities. Therefore, pregnant women should avoid high-dose vitamin A supplements and limit consumption of liver products, which are rich in preformed vitamin A.
- Drugs Recently withdrawn from the market
Some drugs have been removed from the market due to safety concerns, such as severe cardiovascular risks, liver toxicity, or inefficacy. These withdrawals highlight the need for continued vigilance and post-market surveillance to protect public health.
- Rofecoxib (Vioxx): Withdrawn due to increased risk of heart attack and stroke associated with long-term, high-dosage use.
- Benfluorex (Mediator): Withdrawn after being linked to heart valve disease and associated fatalities.
III. Phenylpropanolamine (PPA): Removed from the market due to an increased risk of hemorrhagic stroke, particularly in young women.
Staying informed about these developments enables healthcare professionals to provide the highest standard of care and keep patients safe.
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