Serious Watch on 13 Drugs by FDA – Big Question Will Some Be Banned Soon?

Drugs are introduced in the market only after vigorous clinical testing. However, some adverse effects appear only after they are used in the general population.  Serious adverse effects regarding 13 drugs have been reported to the FDA between July and September 2010.  The FDA is currently keeping a careful watch to see if these drugs actually result in the reported side effects, and whether further regulatory changes like restricting their use may be needed.   These drugs are mentioned below:

1. Benzonatate (Tessalon):  Benzonatate is a local anesthetic used to control cough.  Accidental ingestion has resulted in death in some children less than 10 years of age.

2. Dronedarone hydrochloride (Multaq): Dronedarone is a drug used to treat arrhythmias or abnormal heart rhythms.  It has been reported to increase the anticoagulant effect of warfarin when the two drugs were used together.

3. Epoetin alfa (Epogen/Procrit): Epoetin alfa is human recombinant erythropoietin that stimulates the production of red blood cells.  The formulation of epoetin alfa was reported to be contaminated with small glass flakes called lamellae.  The lamellae could cause adverse effects like increased blood clotting and local reactions.  The manufacturing company Amgen has recalled certain lots of the drug due to this contamination.

4. Gemcitabine hydrochloride (Gemzar):  Gemcitabine is an anticancer drug.  It has been reported to cause veno-occlusive liver disease or blockage of small hepatic veins.

5. Lanreotide acetate (Somatuline depot):  Lanreotide is a drug similar to a hormone found in the body called somatostatin.  It is used to treat adult patients suffering from excess growth hormone, a condition called acromegaly.  It has caused severe cases of pancreatitis.

6. Lanthanum carbonate (Fosrenol): Lanthanum carbonate is used to reduce phosphate levels in the blood in patients with kidney failure.  However, it has caused swallowing complications and obstruction in the digestive tract due to hardness of the tablet

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7. Levetiracetam (Keppra):   Levetiracetam is a drug used in the treatment of seizures.  It has caused severe skin reactions like Stevens-Johnson’s Syndrome and Toxic Epidermal Necrolysis.

8. Lithium citrate:  Lithium citrate is used for a psychiatric condition called manic depressive psychosis.  It has been found to increase the risk of certain patients manifesting a condition called Brugada Syndrome.  Brugada Syndrome is a hereditary condition in which the patient suffers from ECG changes and sudden cardiac death.

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9. Lopinavir/Ritonavir oral solution (Kaletra):  This antiHIV formulation has been reported to cause serious adverse effects in neonates.

10. Octagam 5%, Immune Globulin Intravenous (Human):  This formulation has been reported to cause increased cases of thromboembolism or blood clots.  This formulation has been voluntarily withdrawn from the US market by its manufacturer.

11. Pioglitazone HCl (Actos):  Pioglitazone is an anti-diabetes drug that could be associated with severe muscle damage, a condition called rhabdomyolysis.  The condition often progresses to kidney failure.

12. Ranolazine (Ranexa): Ranolazine is a drug used to treat angina or chest pain due to reduced blood supply to the heart.  It has been found to increase the risk of rhabdomyolysis in patients taking cholesterol lowering drugs from the statin group.

13. Sodium oxybate (Xyrem): Sodium oxybate is a central nervous system depressant that has been reported to cause death in some patients.

Though the FDA is closely monitoring these drugs for their side effects, it has advised patients and physicians to continue to use the drugs, till these adverse effects are established and further regulations are in place.

Reference:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Surveillance/AdverseDrugEffects/ucm237585.htm

Source-Medindia