Darvon Side Effects Lawsuit

              Darvon, propoxyphene hydrochloride capsules, is used to relieve mild to moderate pain. It is a white crystalline, odorless powder wit h a bitter tasted.  The drug is soluble freely in water and has a molecular weight of 375.94. Darvon is chemically 2S,3R)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride.

              Darvon capsules are supplied as 65mg, opaque pink capsules with “Darvon” imprinted in edible black ink on the body. They are provided in bottles of 100. Each capsule contains 65 mg (172.9 µmol) propoxyphene hydrochloride as well as other inactive ingredients such as D & C Red No. 33, F D & C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide.

              The recommended dose of Darvon is 65mg,  or one capsule, every 4 hours. The recommended maximum dose of the drug is 390mg/day. Patients with hepatic or renal impairment should consider a reduced total daily dose of Daevon.

              Poison Control Center should be called to obtain the most up-to-date information about the treatment of overdose if one were to ever occur. If a propoxyphene overdose were to occur, attention should first be focused on establishing a patent airway and restoring ventilation. Ventilation assisted mechanically, with or without oxygen, may be required and if pulmonary edema is present, positive pressure respiration may be desirable. Antagonist nalxone, the narcotic, will reduce the degree of respiratory depression. 0.4mg to 2mg should be administered, preferably intravenously, promptly.

Darvon Side Effects Lawsuit

             Darvon Side Effects Lawsuit For treatment of propoxyphene overdosage in pediatric patients a naloxone initial dose of 0.01mg/kg of child’s body weight may be given intravenously but if the desired degree of clinical improvement does not result, a subsequent increased dose may be administered of 0.1 mg/kg body weight.  If administration is not available through an IV route, naloxone may be administered IM or subcutaneously in separated doses. Naloxone can be diluted with sterile water for injection if necessary. Blood gases, pH, and electrolytes should be monitored so that acidosis and any electrolyte disturbance in attendance may be corrected without delay. Electrocardiographic monitoring is vital as well as general supportive measures , in addition to oxygen. General supportive measures include intravenous fluids when necessary, vasopressor-inotropic compounds, and anti-infective agents when infection is likely. Gastric lavage may also be of use in these situations as well as activated charcoal as it can absorb a great amount of ingested propoxyphene. Since agent such as alcohol, barbiturates, tranquilizers, or other CNS depressants can increase CNS depression as well as cause specific toxic effects, efforts should be made to establish whether other agents were also ingested.

              The symptoms of acute propoxyphene over dosage are the same as narcotic over dosage symptoms. A patient suffering from an overdose usually is somnolent but may be comatose and convulsing. The ventilatory rate is decreased, which results in cyanosis and hypoxia and pupils may become dilated as hypoxia increases. Unless the respiratory depression is corrected and adequate ventilation is restored promptly, blood pressure falls and cardiac performance deteriorates ultimately resulting in pulmonary edema and circulatory collapse. If large amounts of salicylates have also been ingested acidosis may be severe. Death may occur.

              Some adverse reactions and side effect associated with propoxyphene hydrochloride are:

·       Constipation

·       abdominal pain

·       skin rashes

·       lightheadedness

·       headache

·       weakness

·       euphoria

·       dysphoria

·       hallucinations and minor visual disturbances

·       dizziness

·       sedation

·       nausea and vomiting

·       abnormal liver function tests

·       instances of reversible jaundice

Earlier this year the consumer advocacy group petitioned for Darvon to be removed from the market. The request was rejected by the FDA but but are now requiring the makers of Darvon, Darvocet and other painkillers that contain propoxyphene to strengthen the drugs’ labels, including their boxed warning, to emphasize the potential for overdose.

Darvon Side Effects Lawsuit