Patent Law

Tendinitis and Tendon Rupture Lead to Black Box Warning
An increased risk of tendinitis and tendon rupture has lead the FDA to seek a black box warning for fluoroquinolone antimicrobial drugs. The manufacturers of the drugs must also create a medication guide for patients, regarding the possible side effects...

FDA notifies fluoroquinolone manufacturers of Boxed Warning detailing drug risks
--> FDA notifies fluoroquinolone manufacturers of Boxed Warning detailing drug risks New analysis finds increased risk of tendinitis, tendon rupture Related Pages: Bayer AG Depomed, Inc...

Cipro Warning An Overreaction
I read an interesting article in The Brownsville Herald that says physicians aren't worrying so much about the proposed label warning and still plan on prescribing them. They say that if used both properly and sparingly, Cipro and other fluoroquinolones are safe for most patients...

FDA Seeks New Warning for Epilepsy Drugs
Roughly 2.7 million Americans have epilepsy, according to government estimates and many forms of epilepsy are caused by a traumatic brain injury. The Food and Drug Administration is recommending a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of an advisory panel meeting...

Dep't of Silly Warnings
At the VC, Eugene notes a recent Travel Channel warning: "This program contains indigenous nudity. Parental discretion is advised." Not bad. But my ongoing, flabbergasting favorite is still the warning that the MPAA now uses in some cases, warning that a movie contains "thematic elements...

Note to self: Heed the warning labels
I’m one of those people who takes warning labels with a grain of salt, figuring they are over-blowing things due to fear of litigation. Apparently this is not the case with the Cymbalta warning: “Do NOT drink alcohol while on this medication...

Cipro
The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin. The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...

FDA Issues Safety Warning About Valproic Acid and Divalproex Sodium
Valproic Acid and Divalproex Sodium FDA Issues Safety Warning About Risk for Birth Defects

FDA Issues Warning Regarding Topical Ibuprofen Drug Products
Topical Ibuprofen Drug Products FDA Issues Warning Letters

FDA Issues Warning about Promethazine Hydrochloride Injection
Promethazine Hydrochloride Injection FDA issues warning

FDA Review of Prostate Cancer Treatment Prompts Warning of Risk for Diabetes
Prostate Cancer Treatment FDA Review Prompts Warning of Risk for Diabetes

Venom HYPERDRIVE 3.0
FDA Issues Warning