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.
When was the last time you read the fine print on a prescription drug, much less the two pages of boring clinical data that follows each drug advertisement in magazines? If you’re like most people, you skip right past.
The FDA knows this, and they’re now changing their tune to get manufacturers to focus on less, but more important data information in their drug ads.
A new study out this month suggests that a popular class of drugs known as proton pump inhibitors used by millions of people daily may contribute to heart attacks and cardiovascular death.
The results were released this week in the online journal Public Library of Science, or PLOS One. Researchers based at Stanford University tracked more than 16 million medical records from 2.9 million patients.
A class of antibiotics relied on for years for serious infections are being overused, says a consumer group advocating for tougher warnings from the FDA. And now, with numerous cases surfacing of patients suffering nerve damage, some are filing lawsuits against the drug makers.
Fluoroquinolones are synthetic antibiotics designed to be used in cases of serious infection. The precursor to these, quinolones, have been in use since the late 1970s. Since then, they have undergone at least four generational evolutions to maintain effectiveness and name brand protection against generics.
When the dust settled last May on years of litigation over bleeding risks from the blockbuster anticoagulant Pradaxa, German manufacturer Boehringer Ingelheim had agreed to pay $650 million to compensate around 4,000 patients and surviving family members.
The problem with the settlement, legal experts pointed out, was that Pradaxa was still being prescribed to millions of new patients with little warning of the potential for internal bleeding. And, those hospitalized after May 2014 would not receive compensation.
Not fair, said a group of leading drug injury law firms, who have commenced plans to start new Pradaxa litigation in a different court this year.