Recalls and warnings
A recall by Unichem Pharmaceuticals (USA), Inc. of hydrochlorothiazide tablets, 25-mg 1,000-count bottle, because of potential presence of foreign tablets. This recall was initiated as a precautionary measure, as a clopidogrel tablet was found in a bottle of the product. The risk associated with mistakenly taking a clopidogrel tablet instead of a hydrochlorothiazide tablet is the increased probability of experiencing side effects such as bleeding and/or bruising. Patients with active bleeding or who are allergic to clopidogrel may experience more serious adverse health consequences. There have been no reports of adverse events.
A warning about confusion between the antidepressant vortioxetine (Brintellix) and anti-blood-clotting medication ticagrelor (Brilinta) resulting in the wrong medication being prescribed or dispensed, due to the similarity of their brand names. Clinicians can reduce the risk of name confusion by including the generic name of the medication, in addition to the brand name, and the indication for use when prescribing these medications, the FDA said.
A recall of 3 lots of prolotherapy with phenol injection by Hartley Medical because of concerns regarding sterility. There have been no reports of product contamination and/or adverse events related to this recall. This product is used for neurolysis and is packaged in clear 5-mL and 100-mL sterile vials.
A warning that fingolimod (Gilenya) has resulted in cases of rare brain infection. A case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking the drug for multiple sclerosis (MS). These are the first cases reported in patients taking the immunomodulator who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. Information about these recent cases is being added to the drug label.
A recall of human and veterinary sterile compounded drugs by Moses Lake Professional because of lack of sterility assurance upon recent inspection.
Flibanserin (Addyi) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. This 100-mg, once-nightly medication has a potentially serious interaction with alcohol; therefore, treatment will only be available through certified health care professionals and pharmacies, and alcohol use is contraindicated.
In 3 randomized, double-blind, placebo-controlled trials, the drug increased the number of satisfying sexual events by 0.5 to 1 additional event per month, increased sexual desire score by 0.3 to 0.4, and decreased the distress score related to sexual desire by 0.3 to 0.4.
The most common adverse reactions are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. The drug can cause hypotension and syncope, and these risks are increased and more severe when patients drink alcohol or take it with moderate or strong CYP3A4 inhibitors.
Daclatasvir (Daklinza) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. This is the first drug that has demonstrated safety and efficacy to treat genotype 3 without the need for co-administration of interferon or ribavirin. In a trial, 98% of treatment-naive participants with no cirrhosis and 58% of those with cirrhosis achieved sustained virologic response taking daclatasvir, 60 mg, plus sofosbuvir, 400 mg, once daily.
Among treatment-experienced patients, 92% of those with no cirrhosis and 69% of those with cirrhosis were successfully treated. The most common side effects were fatigue and headache. The drug carries a warning that serious symptomatic bradycardia sometimes requiring pacemaker intervention has been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir.
Alirocumab (Praluent) injection to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in addition to diet and maximally tolerated statin therapy. It is the first in a new class, PCSK9 inhibitors.
In trials of 2,476 participants, those taking the drug had an average reduction in LDL cholesterol ranging from 36% to 59% compared to placebo. The most common side effects include itching, swelling, pain, or bruising where injection is given, nasopharyngitis, and flu. Allergic reactions, such as hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization, have been reported.
Combined ombitasvir, paritaprevir, and ritonavir (Technivie) for use in combination with ribavirin for the treatment of HCV genotype 4 infections in patients without scarring and cirrhosis. This is the first approved drug for genotype 4 HCV infections without the need for co-administration of interferon. In a trial, 100% of those who received the combination with ribavirin achieved a sustained virologic response, as did 91% of those who received it without ribavirin.
The most common side effects with ribavirin were fatigue, asthenia, nausea, insomnia, pruritus, and other skin reactions. The drug carries a warning about elevations of liver enzymes to greater than 5 times the upper limit of normal, which occurred in approximately 1% of trial participants, more frequently in females taking contraceptives containing ethinyl estradiol. Such contraceptives must be discontinued prior to starting the drug.
A notice that the FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents for MRI. Studies have reported that deposits of these agents remain in the brains of some patients who undergo 4 or more contrast MRI scans, long after the last administration. It is unknown whether these deposits are harmful or can lead to adverse health effects.