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Product Alert

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 “FDA WARNING”.

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

WASHINGTON -- 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 â€” the agencyâ€™s most serious â€” for a second brand of CooperVisionâ€™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.

Consumer Group Urges Boxed Warning for PPIs

Citing research showing that withdrawal of proton pump inhibitors (PPIs) leads to severe rebound acid secretion -- potentially leaving patients permanently dependent on the drugs -- the consumer group Public Citizen has told the FDA that it should require black-box warnings with the drugs.

Pill Mix-Ups Force Acetaminophen Product Recalls

Two drug manufacturers have recalled a number of products that contain acetaminophen because of mislabeling that could result in overdoses.

New Warning on Valproate Drugs in Pregnancy

Labels for valproate sodium and related drugs for epilepsy will carry new language warning that children exposed to these agents during gestation may suffer cognitive deficits, the FDA said.

OTC Wart Remover Yanked Because of Burn Risk

An OTC wart remover product has been recalled by its manufacturer after the company learned that its active ingredient -- calcium oxide -- can cause severe chemical burns, the FDA announced.

Cordis to Stop Making Cypher, Nevo Stents

Cypher, the first drug-eluting coronary stent to receive FDA approval, will be discontinued at the end of the year, according to manufacturer Cordis.

Cancer Risk Forces Actos Off French, German Markets

Drug regulators in Germany and France have ordered doctors to stop prescribing the type 2 diabetes drug pioglitazone (Actos), following a French study suggesting a heightened risk of bladder cancer.

FDA Warns Against Use of High-Dose Simvastatin

The highest approved dose of simvastatin -- 80 mg -- should be used only in those patients who have already been taking it for at least 12 months without signs of myopathy, the FDA announced Wednesday.

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