Archive for the ‘FDA’ Category

Import ban of 30+ generic drugs from India & melamine-contaminated milk from China

September 17, 2008

More than thirty (30) drugs which include acyclovir, cirprofloxacin and simvastatin, manufactured in two Ranbaxy Laboratories (Dewas and Poenta Sahib plants) in India will not be permitted into the US. Without asking for recall of drugs already on the shelf, the Food Drug Administration (FDA,) the decision is based on the lack of compliance to safety and manufacturing standards by the Indian drug company.

The Food Drug Administration says no report of harm has been so far reported.

List of Drugs with Stop Order

acyclovir, cefprozil, cefuroxime axetil, cephalexin, ciprofloxacin HCl, clarithromycin, fenofibrate, fluconazole, fosinopril sodium, fosinopril sodium and hydrochlorothiazide, gabapentin, glimepiride, isotrentinoin, lamivudine, loratadine OTC, metformin HCl, nefazodone HCl, nitrofurantoin, nitrofurantoin and macrocystalline, ofloxacin, pravastatin sodium, ranitidine, simvastatin, terazozin HCl, valacyclovir HCl, and zidovudine (PEPFAR).” Medical News Today (09/16/08, Agus, Z, MD)

In a similar vein, in a growing scare after imported milk laced with melamine, a chemical substance used to “increase protein content” of milk has been reported to have killed undetermined number of babies and sickened at least 1,253 babies in China. It’s the same chemical that killed pet dogs in USA and Europe afte being fed imported Chinese milk reported earlier.

Melamine, an industrial chemical used to make plastics such as plates and saucers, is known to cause urinary malfunction, stones and failure of the kidneys when ingested.

Toxic History of China’s Products

— Half of all dangerous goods seized in Europe in 2007 came from China
— Last year China found two companies guilty of intentionally exporting contaminated pet food
— US authorities last year gave warning that monkfish imported from China may be puffer fish, containing a potentially deadly toxin
— In 2005 Sudan 1, a carcinogenic food colouring, was found in Chinese branches of KFC
— In January a survey found almost two thirds of Chinese people were worried about food safety
Sources: European Commission, Times archives /TimesOnline(09/15/08)/ChinaDaily/Reuters

Produced by Sanlu, China’s biggest milk power-maker halted its milk production. Ninetten (19) people were arrested in connection with the scandal of greed and lack of concern for people’s lives. The investigation of the scandal was delayed by a ban of news of this nature during the Beijing Olympics.

These two reports have practical implications in the Philippines who partly rely on India for its imports of medicines. They have more resonance with the passage of the Cheap Drug Legislation of 2008 signed into law of Pres. Gloria M. Macapagal. China also sells products to the Philippines which need tighter watch for adulteration and toxic contamination. =0=

UPDATE: On September 25, 2008, the PDI reported that 2 million kilos of milk was imported by the Philippines from China from Jan. to Aug. 2008. As the scandal of the melamine-contaminated milk widens worldwide, about 53,000 children, mostly in China, have been reported to have been sickened and several babies died. The DOH is monitoring hospitals for reports of children getting sick as result of ingesting milk and milk products.

For safety, FDA monitors 20 drugs in the market

September 8, 2008

A 2007 federal law requires the Food and Drug Administration (FDA) to disclose reports from doctors, patients, hospitals, nurses and pharmaceutical companies problems surrounding a particular drug—from simple drug labelling concerns to serious side effects. The list doesn’t automatically imply that the drugs are unsafe and patients don’t necessarily have to stop their medications.

Product Name:
Active Ingredient (Trade)
or Product Class—————————-Potential Serious Risk/New Safety Info.

Arginine Hydrochloride Injection (R-Gene 10)—-Pediatric overdose due to labeling
Desflurane (Suprane)—————————-Cardiac arrest (heart stops working)
Duloxetine (Cymbalta)—————————Urinary retention
Etravirine (Intelence)—————————–Hemarthrosis (blood in a joint)
Fluorouracil Cream (Carac)
and Ketoconazole Cream (Kuric)—————Adverse events due to name confusion
Heparin ————————————-anaphylactic-type allergic reactions

Icodextrin (Extraneal)—————————Hypoglycemia (low blood sugar)
Insulin U-500 (Humulin R)———————-Dosing confusion
Ivermectin (Stromectol) and Warfarin———Drug interaction
Lapatinib (Tykerb)——————————-Hepatotoxicity (liver toxicity)
Lenalidomide (Revlimid)————————–Stevens-Johnson syndrome
Natalizumab (Tysabri)—————————-Skin melanomas (deadly skin cancer)

Nitroglycerin (Nitrostat)————————–Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR)—-Ileus (bowels not moving)
Oxycodone Hydrochloride
Controlled-Release (OxyContin)——————-Drug misuse, abuse, and overdose
Perflutren Lipid Microsphere (Definity)———-Cardiopulmonary reactions
Phenytoin Injection (Dilantin)———————-Purple glove syndrome
Quetiapine (Seroquel)——————————Overdose due to labeling confusion
Tebivudine (Tyzeka)———————————Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers———-Pediatric cancers

For the first time, a quarterly report covering January 1 to March 31 2008 is issued scrutinizing certain medicines for their safety. Once the result of the drug evaluation is out, whether the drug has adverse effects or is confirmed safe, it will be reported in the Adverse Event Reporting System (ARES)to alert the public. Part of a drug safety initiative, the report evaluates the seriousness of a side-effect or if there is something unknown for a particular medicine which can pose a health problem. Source: WebHealthNews (09/05/08, DeNoon, DJ/Chang,L)=0=


Supreme Court Courage Needed

Intelligence can be inherited, education can be bought, expertise can be trained but courage is one thing that cannot be taught. And it is courage that is utterly lacking in our Supreme Court for a long time now. It a virtue Senators Diokno and Joker Arroyo had in abundance.”—MyTy, Philippines