#LegallySpeaking: A Serious Complication of Nitrofurantoin
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Tip: "Guidance for monitoring should be followed while prescribing an unfamiliar drug."

• Facts of the case:

~ A 70-year-old woman struggled with recurrent urinary tract infections for many years so her Urologists advised her to take antibiotics in the long term as a prophylactic measure and advised alternating between trimethoprim and nitrofurantoin.

~ 16 months after commencing nitrofurantoin, the patient began to feel short of breath so she visited her doctor, GP. He conducted a thorough examination and organized a CXR which reported patchy peribronchial wall thickening and suggested a degree of heart failure. The doctor advised a trial of diuretics, which made no difference.

~ 4 Months Later: The patient was admitted to the hospital in respiratory failure. A high-resolution CT scan showed pulmonary fibrosis, with the likely diagnosis being subacute pneumonitis secondary to treatment with nitrofurantoin.

• Patient's Allegation:

She alleged that her doctor had failed to consider that the long-term use of nitrofurantoin may have caused her symptoms.

• Expert opinion:

~ Medical Protection sought expert opinion from a clinical pharmacologist and a GP, who referred to guidance that stated on nitrofurantoin: “Cautions: on long-term therapy, monitor liver function and monitor for pulmonary symptoms especially in the elderly (discontinue if the deterioration in lung function).”

~ The exact definition of “periodically” is not given. An expert's view, it should have been every six months.

~ The case against the doctor was dropped, since the doctor had documented a very thorough history and examination, and made a reasonable initial management plan.

~ However, the practice partners faced a claim regarding the alleged lack of a practice system for monitoring for lung and liver complications in patients on long-term nitrofurantoin.

• Learning point: Expert opinion sought on these claims advises that guidance for monitoring should be followed.

Source: https://www.medicalprotection.org/
N●●●●i V●●s and 15 others like this9 shares
Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
What a serious headache. In a country where even high class Azithromicin is available as an OTC,such a thorough knowledge of a gazillion antibiotics presents the need for consulting every single medical note before prescribing every patient. Indeed,it is a matter of serious concern. Unless some level of conter compensation of every aggreeived party is not demanded for,the patients will feel emboldened instead of backing down and coming to the negotiations table. The path to Court must be discouraged to the patients as much as possible. Certainly such patients need to be blacklisted and a common list prepared and distributed among local IMA chapters. Discouragement of discounts,non acceptance and referrals,must now be started on our side to prevent further erosion of public confidence. Stricter consents are needed. I welcome further discussion in these matters. When court cases begin coming even for rare side effects spread over more than 6months for antibiotics whose quality in India origin has been regularly slammed by US FDA, the invisible Line Of Control has been crossed.... Read more
Jun 3, 2020Like3
Dr. S●●●●●●r K●●●●i
Dr. S●●●●●●r K●●●●i Ear, Nose and Throat disorders
True. Unless the drug controller passes an order to limit sales of antibiotics to only prescribed by registered modern medicine ( allopathic ) doctors and high end antibiotics to only specialists, this problem is not getting resolved. Even MSRs of reputed medical companies depend on “RMPs” for sales. With this even spurious drugs also will come down as the limited sales will allow only big reliable industries to survive... Read more
Jun 4, 2020Like