FDA releases newest list of safety concerns
The U.S. Food and Drug Administration has released its most recent list of probable drug safety issues, referring to Roche’s breast cancer medication Herceptin and Sanofi Aventis’ drug for heart disease Multaq, amid others.
The list that comes out every quarter of the year envelops safety concerns that the FDA wilted between April and June and was propagated on the website of the agency on Friday.
Among the drugs included are Merck & Co Inc’s birth control medication Implanon, Novartis’ Afinitor and Pfizer’s antibiotic Cleocin.
Also associated are Takeda Pharmaceutical’s gout control drug Uloric, AMAG Pharmaceutical’s anemia drug Feraheme and Shire Plc’s phosphate binder Fosrenol were also incorporated, among the drugs involved.
In most of the instances, the FDA presented some clues into what the issues were and plainly stated that the agency is maintaining to weigh up the concern to know if there is a need for any regulatory measures.
The drugs that also listed were a variety of GnRH agonists’ drugs, HIV drug Invirase and Merck’s cholesterol drug Zocor. However, the health agency has presently issued more comprehensive safety alerts on those drugs involved. Moreover, Genentech is a unit of Roche.
Nucynta, a treatment to pain by Johnson & Johnson’s, was also listed as containing a danger of convulsions, hallucinations and syndrome of serotonin.
Furthermore, the health agency also named products such as omeprazole, which is taken to treat patients with ulcer, stating that there is a hazard in talking the drug for it could cause magnesium in the blood to decrease in levels.
However, the drug makers were not instantly available to make any comment for their products. With the coming days, it is expected that representatives from the respective drug manufacturers will going to make a statement for the said safety concerns over their products.
