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Product Alert

A box of Xeljanz (tofacitinib) tablets over a background of thumbs down icons

JAK Inhibitor Misses Endpoint in Safety Study. Now What?

Major blow to popular class of oral rheumatology drugs

A RECALL ALERT stamp over a bottle of Metformin Extended Release tablets

Metformin Recalls Ballooned in 2020

Last addition to the list in November brought number to 254 products recalled

HFSA over a computer rendering of an EKG over a transparent figure clutching their glowing heart

Virtual Heart Failure Care No Substitute for the Face-to-Face Visit?

Reduced GDMT titration suggests a dip in quality of care

A red magic marker draws an X over a black box warning

FDA Drops Boxed Warning From Invokana Label

Amputation risk "lower than previously described"

A blue-gloved hand holds a box of Hydroxychloroquine tablets

HCQ No Longer Approved Even a Little for COVID-19

Study after study showed no benefit, and now the FDA has had enough

METFORMIN over a photo of a glucose meter and test strips above FDA RECALL

NDMA Prompts Metformin Recall

FDA finds certain products with excessive levels of potential carcinogen

SOLD OUT over a bottle of Midazolam

COVID-19 Puts ICU Sedatives Into Shortage

Manufacturers caught short by soaring demand

The packaging of Singulair

Montelukast Warning Upgraded

Existing risk information not prominent enough and needs a black box, FDA decides

Lorcaserin (BELVIQ) over a photo of a man measuring his large belly above FDA RECALL

Diet Drug Yanked Over Cancer Risk

Patients should stop taking lorcaserin

The box, bottle, and pill of the drug Addyi above 鈥淔DA WARNING鈥�.

FDA Loosens Alcohol Warning for Addyi

But refuses drugmaker's demand to remove black box

FDA Issues 'Clean' List for Sartan Drugs

Nitrosamine-free ARBs do exist, agency stresses

Potentially Fatal Immune Reactions to Lamotrigine Draw FDA Warning

Eight serious events including one death since drug was approved in 1994

FDA Warns on Bulk Caffeine

Illegal to sell directly to consumers, agency says

Device May Ease Fistula Creation

Catheter-based, ultrasound-guided device had good long-term patency

Largest AED Maker to Halt Most Operations as FDA Cites Problems

Quality controls have not been up to FDA standards

FDA Warns on MRI in Patients with Implantable Pumps

Medication, mechanical issues may follow exposure

FDA Warns on Cardiac Surgery Heater-Cooler Device

Cites mycobacterial contamination risk

FDA Warns of Heart Risk with Imodium

Permanent and fatal arrhythmias tied to misuse of loperamide

Use of Expired Auto-Injectors OK'd by FDA

WASHINGTON -- The FDA cautioned emergency medical staff to retain recently expired auto-injectors by Meridian Medical Technologies and to use them in emergencies if no other product is available.

FDA Adds GI Warning to Benicar Label

WASHINGTON -- The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about risk of the intestinal condition known as sprue-like enteropathy to the drug's label.

CDC: Cut Back on Doxycycline Use

A continuing shortage of doxycycline means the drug should be used only for conditions that have no alternative treatments, the CDC advised this week.

NuPathe's Patch for Migraine Wins FDA Approval

WASHINGTON -- Adults with migraine will soon have a new treatment option -- Zecuity, a transdermal, battery-powered sumatriptan patch.

'Rugby' Iron Pills Pulled Due to Drug Mix-Up

锘縒ASHINGTON -- The manufacturer of an iron supplement has recalled one lot of the product due to bottles of the affected lot potentially containing anti-nausea tablets instead.

FDA: Booze and Xyrem Are Dangerous Mix

WASHINGTON -- The FDA is warning healthcare professionals that patients taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem) should not consume alcohol or use central nervous system depressants.

Suboxone Maker Pulls Pills in Favor of Film

The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough.

Brain-Eating Amoeba Came From Faucet

The recent cases of primary amoebic meningoencephalitis represent the first reported instances of U.S. tap water harboring the amoeba that causes the fatal disease, according to CDC researchers.

Oxygen Devices Recalled

WASHINGTON -- The FDA has issued a class I recall of several models of oxygen concentrators because of a potential fire hazard.

New Drug for ED Wins FDA Approval

WASHINGTON -- The PDE-5 inhibitor class of drugs for erectile dysfunction gained its first new member in a decade with the FDA approval of avanafil (Stendra).

FDA Warns of Clot Risk with Yaz, Other OCs

Labels for oral contraceptives that contain drospirenone will now note that studies have shown up to a threefold increased risk of blood clots compared with other birth control pills.

Shire Quits on Fabry Drug

Shire PLC has withdrawn its U.S. application to market an enzyme replacement therapy for Fabry disease, citing an expected FDA demand for controlled clinical trials.

FDA Issues Warning on Acid Reflux Drugs

The FDA warned today that use of proton pump inhibitors -- including popular brands such as Nexium, Prilosec, and Prevacid -- may increase the risk of Clostridium difficile-associated diarrhea.

'Brain-Eating' Amoeba Kills Second Neti Pot User

Louisiana state health officials are warning patients about potential dangers of using tap water for sinus irrigation after two patients died of Naegleria fowleri infection.

FDA Issues Second Contact Lens Recall

WASHINGTON -- The FDA has issued a class I recall 芒鈧€� the agency芒鈧劉s most serious 芒鈧€� for a second brand of CooperVision芒鈧劉s AVAIRA Aquaform contact lenses that may cause serious eye injury.

Low-Dose Zolpidem Gets FDA Okay for Wee-Hours Awakening

A new formulation of the insomnia drug zolpidem tartrate (Ambien) has been approved to treat middle-of-the-night awakenings followed by difficulty returning to sleep, the FDA said.

Tampon Recall Stems from Bacterial Contamination

Kimberly-Clark has announced the recall of a number of Kotex brand tampon lots because of contamination with potentially life-threatening Enterobacter sakazakii.

Linezolid Toxic With Prozac, Other SSRIs, FDA Warns

The FDA has issued an updated statement on the potential for serious central nervous system toxicity when patients taking serotonergic psychiatric drugs are treated with the antibacterial agent linezolid (Zyvox).

FDA Okays ED Drug for Enlarged Prostate

Tadalafil (Cialis), currently marketed for erectile dysfunction, also may be used to treat benign prostatic hyperplasia, the FDA said.

FDA Blocks Sale of Supplements for Parkinson's and Alzheimer's

WASHINGTON -- The FDA filed a permanent injunction against two Minnesota companies that distributed amino acid products marketed as treatments for Parkinson's disease, Alzheimer's disease, and a number of other neurological disorders.

Medtronic Infusion Pump Recalled

Battery problems with two of Medtronic's SynchroMed II implantable infusion pumps have forced the company to recall them, according to the FDA, although the recall only affects products not yet implanted.

FDA Warns Against High-Dose Citalopram

Citing increased risk of cardiac arrhythmias and a lack of therapeutic benefit associated with high doses of the SSRI citalopram hydrobromide (Celexa), the FDA has reduced the recommended maximum to 40 mg/day.

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