In 2004, the FDA warned the public that antidepressant use could increase the risk of suicidal thoughts or actions in adolescents--and it required all makers of antidepressant drugs to add to the drugs a dreaded "black box" warning. Now a group of researchers from Harvard is presenting rather compelling evidence that the FDA's action might have been a mistake.
Execs at India's Dr. Reddy's Laboratories recently highlighted how investments in plant upgrades had taken much of the human involvement out of drug production, but the improvements don't make production fool-proof. The drugmaker is voluntarily recalling a lot of generic Toprol XL as well as an unknown amount of an acid reflux drug it manufactured for someone else.
Last year Alabama-based Medaus Pharmacy withdrew 11 sterile drug products after the FDA raised questions about the lab it was using to test for sterility. The FDA now says the compounder has sterility issues in its own facility which raise questions about the safety of its products.
The FDA has announced it will vote this week on whether a class of drugs that treat opioid-induced constipation needs more clinical testing in light of a side effect: heart attack. The class of drugs includes recently approved products from Salix Pharmaceuticals and Cubist Pharmaceuticals but also one that AstraZeneca is developing with Nektar Theraputics.
Lawsuits have been piling up against Abbott Laboratories and its recent spinoff, AbbVie, maker of one of the top-selling testosterone supplements, AndroGel. A panel of judges has now decided that those suits will be consolidated in Chicago, where both companies are based.
While Victoza brought in more than $2 billion last year, it has been dogged by concerns that it raises the risk of pancreatitis--and despite it and other similar drugs being cleared by reviews by both the FDA and EU regulators this year, some keep pushing the FDA to consider pulling it off the market.
Europe has been pushing the U.S. in trade negotiations to accept their inspections of European drugmakers in lieu of doing their own, and vice versa, but the approach the FDA and European regulators have taken to problems at a Ranbaxy Laboratories plant illustrate why this has become a contentious issue.
Regulators in Vietnam have banned drug imports from dozens of companies, saying they are substandard.
FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.
In the wake of a lawsuit brought by two California counties against five manufacturers of prescription painkillers, the city of Chicago has filed a suit of its own. Chicago is suing the same five pharma companies--alleging, much like California does, that they overstated the benefits of opioid painkillers while deceiving the public about the risks.