Last week, the U.S. Food and Drug Administration approved the long-awaited drug Praxbind, which works in most patients to reverse the effects of the powerful blood thinning medication Pradaxa.
The antidote, developed by German drug maker Boehringer Ingelheim, who also makes Pradaxa, was granted fast-track approval by the FDA due to its usefulness in emergency settings for patients afflicted with internal bleeding.
Earlier this year, the FDA disclosed it had received more than 1,000 side effect complaints from the often-used antibiotics known as fluoroquinolones - Avelox, Levaquin and Cipro.
These side effects range from psychiatric problems to tendon and nerve damage.
In April, DrugNews reported on an FDA report that noted an increasing number of reported side effects among women fitted with the permanent birth control device Essure.
Last week, a panel of independent doctors questioned both the maker of the device, Bayer, and the FDA, on why and how the device was approved for use and why side effects have spiked. They also laid out a plan for further testing to determine the risk to patients.
Two new reports out this month have shed light on the hot-button topic of risking drug prices, offering unchallenged proof that we as Americans are getting ripped off and subsidizing treatment for the rest of the world.
As it stands, the prescription drug and medical device lobbying efforts are the largest in the United States, spending more than $250 million each year to try to persuade our lawmakers. And what these companies repeatedly ask for is less legal rights for patients and less regulation on prices.
According to recent court filings, the FDA has ordered Pfizer to add new warnings to its popular antidepressant Zoloft that the drug may cause certain birth defects when taken during pregnancy.
The move comes as Pfizer continues to deny their drug poses any risk to fetuses, although they now face hundreds of lawsuits from families alleging birth defects.
Among the three new generation oral anticoagulants – Pradaxa, Eliquis and Xarelto – released in the past few years to replace the traditional standby warfarin, Eliquis has made the boldest claims about decreasing the risks of stroke, internal bleeding and death.
However, a new report out last month indicates the data relied upon by Pfizer and Bristol-Myers Squibb in making claims about Eliquis’ safety may be flawed. And, at least one FDA reviewer has called for changes to the drug’s label to reflect this.
For the past decade, diabetes drugs have been among the best-selling pharmaceuticals in the United States. However, they have also been the subject of frequent safety debates and FDA warnings about patient side effects.
In just the past five years, warnings have surfaced over heart risks for Avandia, bladder cancer for Actos, pancreatitis for Januvia and joint pain for Onglyza and Janumet.
They rank among the most-prescribed drugs in the United States each year with over 20 million prescriptions. However, popular type 2 diabetes meds known as DPP-4 inhibitors now carry a new risk according to the FDA.
Last week, the agency issued a safety announcement advising that dipeptidyl peptidase-4 (DPP- 4) inhibitors can cause severe joint pain, and ordered that new products carry an additional warning on their label.
DrugNews reported in May on the growing concern about permanent nerve damage caused by modern synthetic antibiotics. Now, a report shows that with the rising number of lawsuits from those patients affected, a judicial panel has created a multidistrict court to handle the volume.
The drugs Cipro, Avelox and Levaquin are all part of a class of man-made antibiotics called fluoroquinolones. Originally developed in the 1970s, quinolones have been updated several times in recent decades to maintain effectiveness.
Rheumatoid arthritis is a chronic disease of the immune system that affects nearly 1% of all adults with painful joints. Since its effects are best managed with medication, this has netted a multi-billion dollar segment for drug manufacturers.
However, a new report shows the growth of these drugs may present a whole new risk of side effects, including blood disorders and tuberculosis.
August 11, 2015 - For several years now, the popular atrial fibrillation drug Eliquis has enjoyed safe status from litigation, while its chief rivals Pradaxa and Xarelto faced over 10,000 claims alleging patients were hospitalized or killed from internal bleeding.
Much of the calm around Eliquis stemmed from clinical studies reportedly showing it was the safest of the three, less likely to cause patient injury or death, and much safer than the traditional alternative warfarin.
July 7, 2015 - The FDA announced last week it will take a new look at the safety of the permanent birth control implant Essure, after a dramatic rise in the number of side effects reported by patients.
Essure is a small flexible metal coil that is implanted in the fallopian tubes through the cervix and uterus in a non-surgical procedure called hysteroscopic sterilization. Within three months, scar tissue grows around the device, blocking the production of new eggs.